Trial Outcomes & Findings for Injection Versus Splinting in Carpal Tunnel Syndrome (NCT NCT02038452)
NCT ID: NCT02038452
Last Updated: 2023-03-21
Results Overview
Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire
COMPLETED
PHASE4
234 participants
6 weeks
2023-03-21
Participant Flow
Patients were recruited from 25 General Practices and community musculoskeletal clinics between 17/04/2014 and 31/12/2016.
Patients with a positive carpal tunnel syndrome (CTS) diagnosis were assessed for eligibility by the GP/clinician based on the inclusion/exclusion criteria. Patients who were interested in trial participation were then seen by appropriate member of the clinical team who explained the trial in full, and were asked to provide written informed consent. 750 patients were assessed for eligibility. 405 were eligible and 234 subsequently consented to randomisation.
Participant milestones
| Measure |
Steroid Injection
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
Overall Study
STARTED
|
116
|
118
|
|
Overall Study
Baseline
|
113
|
117
|
|
Overall Study
6 Weeks Follow-up
|
108
|
109
|
|
Overall Study
6 Months Follow-up
|
96
|
97
|
|
Overall Study
12 Months Follow-up
|
87
|
88
|
|
Overall Study
24 Months Follow-up
|
78
|
81
|
|
Overall Study
COMPLETED
|
78
|
81
|
|
Overall Study
NOT COMPLETED
|
38
|
37
|
Reasons for withdrawal
| Measure |
Steroid Injection
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
9
|
|
Overall Study
Lost to Follow-up
|
31
|
28
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Steroid Injection
n=116 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=118 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
Total
n=234 Participants
Total of all reporting groups
|
|---|---|---|---|
|
My hand or wrist problem has major consequences on my life
Disagree
|
19 Participants
n=116 Participants
|
22 Participants
n=118 Participants
|
41 Participants
n=234 Participants
|
|
Age, Continuous
|
52.6 years
STANDARD_DEVIATION 17.0 • n=116 Participants
|
52.2 years
STANDARD_DEVIATION 14.9 • n=118 Participants
|
52.4 years
STANDARD_DEVIATION 15.9 • n=234 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=116 Participants
|
81 Participants
n=118 Participants
|
154 Participants
n=234 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=116 Participants
|
37 Participants
n=118 Participants
|
80 Participants
n=234 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
116 participants
n=116 Participants
|
118 participants
n=118 Participants
|
234 participants
n=234 Participants
|
|
First time diagnosed with carpal tunnel syndrome
Yes
|
97 Participants
n=116 Participants
|
102 Participants
n=118 Participants
|
199 Participants
n=234 Participants
|
|
First time diagnosed with carpal tunnel syndrome
No
|
16 Participants
n=116 Participants
|
15 Participants
n=118 Participants
|
31 Participants
n=234 Participants
|
|
First time diagnosed with carpal tunnel syndrome
Missing
|
3 Participants
n=116 Participants
|
1 Participants
n=118 Participants
|
4 Participants
n=234 Participants
|
|
Number of times previously had carpal tunnel syndrome
N/A
|
97 Participants
n=116 Participants
|
102 Participants
n=118 Participants
|
199 Participants
n=234 Participants
|
|
Number of times previously had carpal tunnel syndrome
1
|
11 Participants
n=116 Participants
|
8 Participants
n=118 Participants
|
19 Participants
n=234 Participants
|
|
Number of times previously had carpal tunnel syndrome
2
|
1 Participants
n=116 Participants
|
1 Participants
n=118 Participants
|
2 Participants
n=234 Participants
|
|
Number of times previously had carpal tunnel syndrome
3
|
0 Participants
n=116 Participants
|
0 Participants
n=118 Participants
|
0 Participants
n=234 Participants
|
|
Number of times previously had carpal tunnel syndrome
More than 3
|
3 Participants
n=116 Participants
|
4 Participants
n=118 Participants
|
7 Participants
n=234 Participants
|
|
Number of times previously had carpal tunnel syndrome
Missing
|
4 Participants
n=116 Participants
|
3 Participants
n=118 Participants
|
7 Participants
n=234 Participants
|
|
Hand or wrist previously affected by carpal tunnel syndrome
N/A
|
97 Participants
n=116 Participants
|
102 Participants
n=118 Participants
|
199 Participants
n=234 Participants
|
|
Hand or wrist previously affected by carpal tunnel syndrome
Right
|
6 Participants
n=116 Participants
|
3 Participants
n=118 Participants
|
9 Participants
n=234 Participants
|
|
Hand or wrist previously affected by carpal tunnel syndrome
Left
|
1 Participants
n=116 Participants
|
2 Participants
n=118 Participants
|
3 Participants
n=234 Participants
|
|
Hand or wrist previously affected by carpal tunnel syndrome
Both
|
8 Participants
n=116 Participants
|
9 Participants
n=118 Participants
|
17 Participants
n=234 Participants
|
|
Hand or wrist previously affected by carpal tunnel syndrome
Missing
|
4 Participants
n=116 Participants
|
2 Participants
n=118 Participants
|
6 Participants
n=234 Participants
|
|
Treatment for previous carpal tunnel syndrome
N/A
|
97 participants
n=116 Participants
|
102 participants
n=118 Participants
|
199 participants
n=234 Participants
|
|
Treatment for previous carpal tunnel syndrome
Steroid injection
|
3 participants
n=116 Participants
|
4 participants
n=118 Participants
|
7 participants
n=234 Participants
|
|
Treatment for previous carpal tunnel syndrome
Wrist splint
|
7 participants
n=116 Participants
|
4 participants
n=118 Participants
|
11 participants
n=234 Participants
|
|
Treatment for previous carpal tunnel syndrome
Carpal tunnel decompression
|
3 participants
n=116 Participants
|
2 participants
n=118 Participants
|
5 participants
n=234 Participants
|
|
Treatment for previous carpal tunnel syndrome
Ultrasound
|
1 participants
n=116 Participants
|
1 participants
n=118 Participants
|
2 participants
n=234 Participants
|
|
Treatment for previous carpal tunnel syndrome
Exercises
|
0 participants
n=116 Participants
|
0 participants
n=118 Participants
|
0 participants
n=234 Participants
|
|
Treatment for previous carpal tunnel syndrome
Vitamin supplements
|
0 participants
n=116 Participants
|
1 participants
n=118 Participants
|
1 participants
n=234 Participants
|
|
Treatment for previous carpal tunnel syndrome
Changes in workplace
|
0 participants
n=116 Participants
|
0 participants
n=118 Participants
|
0 participants
n=234 Participants
|
|
Treatment for previous carpal tunnel syndrome
Other
|
1 participants
n=116 Participants
|
0 participants
n=118 Participants
|
1 participants
n=234 Participants
|
|
Treatment for previous carpal tunnel syndrome
None
|
5 participants
n=116 Participants
|
8 participants
n=118 Participants
|
13 participants
n=234 Participants
|
|
Steroid injection into a joint other than wrist if previously had carpal tunnel syndrome
N/A
|
97 Participants
n=116 Participants
|
102 Participants
n=118 Participants
|
199 Participants
n=234 Participants
|
|
Steroid injection into a joint other than wrist if previously had carpal tunnel syndrome
Yes
|
9 Participants
n=116 Participants
|
9 Participants
n=118 Participants
|
18 Participants
n=234 Participants
|
|
Steroid injection into a joint other than wrist if previously had carpal tunnel syndrome
No
|
7 Participants
n=116 Participants
|
6 Participants
n=118 Participants
|
13 Participants
n=234 Participants
|
|
Steroid injection into a joint other than wrist if previously had carpal tunnel syndrome
Missing
|
3 Participants
n=116 Participants
|
1 Participants
n=118 Participants
|
4 Participants
n=234 Participants
|
|
Usefulness of injection into other joint if previously had carpal tunnel syndrome
N/A
|
104 Participants
n=116 Participants
|
108 Participants
n=118 Participants
|
212 Participants
n=234 Participants
|
|
Usefulness of injection into other joint if previously had carpal tunnel syndrome
Of great help
|
7 Participants
n=116 Participants
|
7 Participants
n=118 Participants
|
14 Participants
n=234 Participants
|
|
Usefulness of injection into other joint if previously had carpal tunnel syndrome
Of some help
|
1 Participants
n=116 Participants
|
1 Participants
n=118 Participants
|
2 Participants
n=234 Participants
|
|
Usefulness of injection into other joint if previously had carpal tunnel syndrome
Of little help
|
0 Participants
n=116 Participants
|
0 Participants
n=118 Participants
|
0 Participants
n=234 Participants
|
|
Usefulness of injection into other joint if previously had carpal tunnel syndrome
Of no help
|
1 Participants
n=116 Participants
|
1 Participants
n=118 Participants
|
2 Participants
n=234 Participants
|
|
Usefulness of injection into other joint if previously had carpal tunnel syndrome
Missing
|
3 Participants
n=116 Participants
|
1 Participants
n=118 Participants
|
4 Participants
n=234 Participants
|
|
Which problematic hand or wrist
Right
|
36 Participants
n=116 Participants
|
37 Participants
n=118 Participants
|
73 Participants
n=234 Participants
|
|
Which problematic hand or wrist
Left
|
19 Participants
n=116 Participants
|
20 Participants
n=118 Participants
|
39 Participants
n=234 Participants
|
|
Which problematic hand or wrist
Both
|
57 Participants
n=116 Participants
|
59 Participants
n=118 Participants
|
116 Participants
n=234 Participants
|
|
Which problematic hand or wrist
Missing
|
4 Participants
n=116 Participants
|
2 Participants
n=118 Participants
|
6 Participants
n=234 Participants
|
|
If both hands problematic, which hand was worse
N/A
|
55 Participants
n=116 Participants
|
57 Participants
n=118 Participants
|
112 Participants
n=234 Participants
|
|
If both hands problematic, which hand was worse
Right
|
25 Participants
n=116 Participants
|
24 Participants
n=118 Participants
|
49 Participants
n=234 Participants
|
|
If both hands problematic, which hand was worse
Left
|
13 Participants
n=116 Participants
|
19 Participants
n=118 Participants
|
32 Participants
n=234 Participants
|
|
If both hands problematic, which hand was worse
No difference
|
7 Participants
n=116 Participants
|
3 Participants
n=118 Participants
|
10 Participants
n=234 Participants
|
|
If both hands problematic, which hand was worse
Missing
|
16 Participants
n=116 Participants
|
15 Participants
n=118 Participants
|
31 Participants
n=234 Participants
|
|
Dominant hand
Right
|
99 Participants
n=116 Participants
|
99 Participants
n=118 Participants
|
198 Participants
n=234 Participants
|
|
Dominant hand
Left
|
12 Participants
n=116 Participants
|
16 Participants
n=118 Participants
|
28 Participants
n=234 Participants
|
|
Dominant hand
Missing
|
5 Participants
n=116 Participants
|
3 Participants
n=118 Participants
|
8 Participants
n=234 Participants
|
|
Duration of hand or wrist problems
<3 months
|
19 Participants
n=116 Participants
|
17 Participants
n=118 Participants
|
36 Participants
n=234 Participants
|
|
Duration of hand or wrist problems
3-6 months
|
37 Participants
n=116 Participants
|
33 Participants
n=118 Participants
|
70 Participants
n=234 Participants
|
|
Duration of hand or wrist problems
6 months-1 year
|
22 Participants
n=116 Participants
|
27 Participants
n=118 Participants
|
49 Participants
n=234 Participants
|
|
Duration of hand or wrist problems
>1 year
|
34 Participants
n=116 Participants
|
39 Participants
n=118 Participants
|
73 Participants
n=234 Participants
|
|
Duration of hand or wrist problems
Missing
|
4 Participants
n=116 Participants
|
2 Participants
n=118 Participants
|
6 Participants
n=234 Participants
|
|
How did your hand or wrist problems start
Suddenly
|
33 Participants
n=116 Participants
|
17 Participants
n=118 Participants
|
50 Participants
n=234 Participants
|
|
How did your hand or wrist problems start
Gradually
|
79 Participants
n=116 Participants
|
99 Participants
n=118 Participants
|
178 Participants
n=234 Participants
|
|
How did your hand or wrist problems start
Missing
|
4 Participants
n=116 Participants
|
2 Participants
n=118 Participants
|
6 Participants
n=234 Participants
|
|
Particular position causes hand or wrist problems
Yes
|
50 Participants
n=116 Participants
|
62 Participants
n=118 Participants
|
112 Participants
n=234 Participants
|
|
Particular position causes hand or wrist problems
No
|
62 Participants
n=116 Participants
|
54 Participants
n=118 Participants
|
116 Participants
n=234 Participants
|
|
Particular position causes hand or wrist problems
Missing
|
4 Participants
n=116 Participants
|
2 Participants
n=118 Participants
|
6 Participants
n=234 Participants
|
|
Curently taking pain relief
Yes
|
36 Participants
n=116 Participants
|
34 Participants
n=118 Participants
|
70 Participants
n=234 Participants
|
|
Curently taking pain relief
No
|
77 Participants
n=116 Participants
|
83 Participants
n=118 Participants
|
160 Participants
n=234 Participants
|
|
Curently taking pain relief
Missing
|
3 Participants
n=116 Participants
|
1 Participants
n=118 Participants
|
4 Participants
n=234 Participants
|
|
Number of times a day taking pain relief
N/A
|
77 Participants
n=116 Participants
|
83 Participants
n=118 Participants
|
160 Participants
n=234 Participants
|
|
Number of times a day taking pain relief
1
|
7 Participants
n=116 Participants
|
8 Participants
n=118 Participants
|
15 Participants
n=234 Participants
|
|
Number of times a day taking pain relief
2
|
13 Participants
n=116 Participants
|
5 Participants
n=118 Participants
|
18 Participants
n=234 Participants
|
|
Number of times a day taking pain relief
3
|
5 Participants
n=116 Participants
|
5 Participants
n=118 Participants
|
10 Participants
n=234 Participants
|
|
Number of times a day taking pain relief
4
|
3 Participants
n=116 Participants
|
5 Participants
n=118 Participants
|
8 Participants
n=234 Participants
|
|
Number of times a day taking pain relief
5
|
0 Participants
n=116 Participants
|
1 Participants
n=118 Participants
|
1 Participants
n=234 Participants
|
|
Number of times a day taking pain relief
Missing
|
11 Participants
n=116 Participants
|
11 Participants
n=118 Participants
|
22 Participants
n=234 Participants
|
|
Number of days per week taking pain relief
N/A
|
77 Participants
n=116 Participants
|
83 Participants
n=118 Participants
|
160 Participants
n=234 Participants
|
|
Number of days per week taking pain relief
1
|
0 Participants
n=116 Participants
|
0 Participants
n=118 Participants
|
0 Participants
n=234 Participants
|
|
Number of days per week taking pain relief
2
|
1 Participants
n=116 Participants
|
4 Participants
n=118 Participants
|
5 Participants
n=234 Participants
|
|
Number of days per week taking pain relief
3
|
3 Participants
n=116 Participants
|
0 Participants
n=118 Participants
|
3 Participants
n=234 Participants
|
|
Number of days per week taking pain relief
4
|
1 Participants
n=116 Participants
|
0 Participants
n=118 Participants
|
1 Participants
n=234 Participants
|
|
Number of days per week taking pain relief
5
|
2 Participants
n=116 Participants
|
2 Participants
n=118 Participants
|
4 Participants
n=234 Participants
|
|
Number of days per week taking pain relief
6
|
0 Participants
n=116 Participants
|
0 Participants
n=118 Participants
|
0 Participants
n=234 Participants
|
|
Number of days per week taking pain relief
7
|
14 Participants
n=116 Participants
|
7 Participants
n=118 Participants
|
21 Participants
n=234 Participants
|
|
Number of days per week taking pain relief
Missing
|
18 Participants
n=116 Participants
|
22 Participants
n=118 Participants
|
40 Participants
n=234 Participants
|
|
Number of weeks in a month taking pain relief
N/A
|
77 Participants
n=116 Participants
|
83 Participants
n=118 Participants
|
160 Participants
n=234 Participants
|
|
Number of weeks in a month taking pain relief
1
|
1 Participants
n=116 Participants
|
0 Participants
n=118 Participants
|
1 Participants
n=234 Participants
|
|
Number of weeks in a month taking pain relief
2
|
2 Participants
n=116 Participants
|
1 Participants
n=118 Participants
|
3 Participants
n=234 Participants
|
|
Number of weeks in a month taking pain relief
3
|
1 Participants
n=116 Participants
|
0 Participants
n=118 Participants
|
1 Participants
n=234 Participants
|
|
Number of weeks in a month taking pain relief
4
|
17 Participants
n=116 Participants
|
9 Participants
n=118 Participants
|
26 Participants
n=234 Participants
|
|
Number of weeks in a month taking pain relief
Missing
|
18 Participants
n=116 Participants
|
25 Participants
n=118 Participants
|
43 Participants
n=234 Participants
|
|
In a current paid job
Yes
|
58 Participants
n=116 Participants
|
74 Participants
n=118 Participants
|
132 Participants
n=234 Participants
|
|
In a current paid job
No
|
55 Participants
n=116 Participants
|
42 Participants
n=118 Participants
|
97 Participants
n=234 Participants
|
|
In a current paid job
Missing
|
3 Participants
n=116 Participants
|
2 Participants
n=118 Participants
|
5 Participants
n=234 Participants
|
|
If not in a current paid job, describe current position
N/A
|
58 participants
n=116 Participants
|
74 participants
n=118 Participants
|
132 participants
n=234 Participants
|
|
If not in a current paid job, describe current position
Retired
|
38 participants
n=116 Participants
|
29 participants
n=118 Participants
|
67 participants
n=234 Participants
|
|
If not in a current paid job, describe current position
Student
|
3 participants
n=116 Participants
|
1 participants
n=118 Participants
|
4 participants
n=234 Participants
|
|
If not in a current paid job, describe current position
Looking after children/home
|
12 participants
n=116 Participants
|
9 participants
n=118 Participants
|
21 participants
n=234 Participants
|
|
If not in a current paid job, describe current position
Unemployed
|
3 participants
n=116 Participants
|
7 participants
n=118 Participants
|
10 participants
n=234 Participants
|
|
If not in a current paid job, describe current position
Voluntary worker
|
2 participants
n=116 Participants
|
0 participants
n=118 Participants
|
2 participants
n=234 Participants
|
|
Typical weekly working hours
N/A
|
55 Participants
n=116 Participants
|
42 Participants
n=118 Participants
|
97 Participants
n=234 Participants
|
|
Typical weekly working hours
Full time
|
39 Participants
n=116 Participants
|
47 Participants
n=118 Participants
|
86 Participants
n=234 Participants
|
|
Typical weekly working hours
Part time
|
18 Participants
n=116 Participants
|
27 Participants
n=118 Participants
|
45 Participants
n=234 Participants
|
|
Typical weekly working hours
Missing
|
4 Participants
n=116 Participants
|
2 Participants
n=118 Participants
|
6 Participants
n=234 Participants
|
|
Describes current situation in respect of your job
N/A
|
55 Participants
n=116 Participants
|
42 Participants
n=118 Participants
|
97 Participants
n=234 Participants
|
|
Describes current situation in respect of your job
Doing my usual job
|
50 Participants
n=116 Participants
|
62 Participants
n=118 Participants
|
112 Participants
n=234 Participants
|
|
Describes current situation in respect of your job
On paid annual leave/holiday
|
2 Participants
n=116 Participants
|
1 Participants
n=118 Participants
|
3 Participants
n=234 Participants
|
|
Describes current situation in respect of your job
Working fewer hours
|
1 Participants
n=116 Participants
|
2 Participants
n=118 Participants
|
3 Participants
n=234 Participants
|
|
Describes current situation in respect of your job
Doing lighter duties
|
1 Participants
n=116 Participants
|
6 Participants
n=118 Participants
|
7 Participants
n=234 Participants
|
|
Describes current situation in respect of your job
On paid sick leave
|
3 Participants
n=116 Participants
|
3 Participants
n=118 Participants
|
6 Participants
n=234 Participants
|
|
Describes current situation in respect of your job
On unpaid sick leave
|
0 Participants
n=116 Participants
|
0 Participants
n=118 Participants
|
0 Participants
n=234 Participants
|
|
Describes current situation in respect of your job
Missing
|
4 Participants
n=116 Participants
|
2 Participants
n=118 Participants
|
6 Participants
n=234 Participants
|
|
If not doing usual job/annual leave, is this due to your hand or wrist problems
N/A
|
105 Participants
n=116 Participants
|
105 Participants
n=118 Participants
|
210 Participants
n=234 Participants
|
|
If not doing usual job/annual leave, is this due to your hand or wrist problems
Yes
|
2 Participants
n=116 Participants
|
4 Participants
n=118 Participants
|
6 Participants
n=234 Participants
|
|
If not doing usual job/annual leave, is this due to your hand or wrist problems
No
|
3 Participants
n=116 Participants
|
6 Participants
n=118 Participants
|
9 Participants
n=234 Participants
|
|
If not doing usual job/annual leave, is this due to your hand or wrist problems
Missing
|
6 Participants
n=116 Participants
|
3 Participants
n=118 Participants
|
9 Participants
n=234 Participants
|
|
Taken time off work during the last 6 months for your hand or wrist problems
N/A
|
55 Participants
n=116 Participants
|
42 Participants
n=118 Participants
|
97 Participants
n=234 Participants
|
|
Taken time off work during the last 6 months for your hand or wrist problems
Yes
|
8 Participants
n=116 Participants
|
5 Participants
n=118 Participants
|
13 Participants
n=234 Participants
|
|
Taken time off work during the last 6 months for your hand or wrist problems
No
|
49 Participants
n=116 Participants
|
69 Participants
n=118 Participants
|
118 Participants
n=234 Participants
|
|
Taken time off work during the last 6 months for your hand or wrist problems
Missing
|
4 Participants
n=116 Participants
|
2 Participants
n=118 Participants
|
6 Participants
n=234 Participants
|
|
I feel my welfare is important to my employer
N/A
|
104 Participants
n=116 Participants
|
111 Participants
n=118 Participants
|
215 Participants
n=234 Participants
|
|
I feel my welfare is important to my employer
Strongly disagree
|
0 Participants
n=116 Participants
|
0 Participants
n=118 Participants
|
0 Participants
n=234 Participants
|
|
I feel my welfare is important to my employer
Disagree
|
0 Participants
n=116 Participants
|
0 Participants
n=118 Participants
|
0 Participants
n=234 Participants
|
|
I feel my welfare is important to my employer
Agree
|
4 Participants
n=116 Participants
|
3 Participants
n=118 Participants
|
7 Participants
n=234 Participants
|
|
I feel my welfare is important to my employer
Strongly agree
|
4 Participants
n=116 Participants
|
2 Participants
n=118 Participants
|
6 Participants
n=234 Participants
|
|
I feel my welfare is important to my employer
Missing
|
4 Participants
n=116 Participants
|
2 Participants
n=118 Participants
|
6 Participants
n=234 Participants
|
|
Which treatment would you prefer
Strongly prefer wrist injection
|
13 Participants
n=116 Participants
|
13 Participants
n=118 Participants
|
26 Participants
n=234 Participants
|
|
Which treatment would you prefer
Somewhat prefer wrist injection
|
11 Participants
n=116 Participants
|
21 Participants
n=118 Participants
|
32 Participants
n=234 Participants
|
|
Which treatment would you prefer
No preference
|
65 Participants
n=116 Participants
|
60 Participants
n=118 Participants
|
125 Participants
n=234 Participants
|
|
Which treatment would you prefer
Somewhat prefer night splints
|
12 Participants
n=116 Participants
|
8 Participants
n=118 Participants
|
20 Participants
n=234 Participants
|
|
Which treatment would you prefer
Strongly prefer night splints
|
6 Participants
n=116 Participants
|
10 Participants
n=118 Participants
|
16 Participants
n=234 Participants
|
|
Which treatment would you prefer
Missing
|
9 Participants
n=116 Participants
|
6 Participants
n=118 Participants
|
15 Participants
n=234 Participants
|
|
If you had received wrist injection, would you expect your symptoms to improve
Yes
|
69 Participants
n=116 Participants
|
70 Participants
n=118 Participants
|
139 Participants
n=234 Participants
|
|
If you had received wrist injection, would you expect your symptoms to improve
No
|
0 Participants
n=116 Participants
|
2 Participants
n=118 Participants
|
2 Participants
n=234 Participants
|
|
If you had received wrist injection, would you expect your symptoms to improve
Not sure
|
39 Participants
n=116 Participants
|
41 Participants
n=118 Participants
|
80 Participants
n=234 Participants
|
|
If you had received wrist injection, would you expect your symptoms to improve
Missing
|
8 Participants
n=116 Participants
|
5 Participants
n=118 Participants
|
13 Participants
n=234 Participants
|
|
If you received night splint, would you expect your symptoms to improve
Yes
|
46 Participants
n=116 Participants
|
40 Participants
n=118 Participants
|
86 Participants
n=234 Participants
|
|
If you received night splint, would you expect your symptoms to improve
No
|
3 Participants
n=116 Participants
|
4 Participants
n=118 Participants
|
7 Participants
n=234 Participants
|
|
If you received night splint, would you expect your symptoms to improve
Not sure
|
58 Participants
n=116 Participants
|
69 Participants
n=118 Participants
|
127 Participants
n=234 Participants
|
|
If you received night splint, would you expect your symptoms to improve
Missing
|
9 Participants
n=116 Participants
|
5 Participants
n=118 Participants
|
14 Participants
n=234 Participants
|
|
My hand or wrist problem will last for a long time
Strongly disagree
|
3 Participants
n=116 Participants
|
3 Participants
n=118 Participants
|
6 Participants
n=234 Participants
|
|
My hand or wrist problem will last for a long time
Disagree
|
7 Participants
n=116 Participants
|
8 Participants
n=118 Participants
|
15 Participants
n=234 Participants
|
|
My hand or wrist problem will last for a long time
Neither agree nor disagree
|
45 Participants
n=116 Participants
|
51 Participants
n=118 Participants
|
96 Participants
n=234 Participants
|
|
My hand or wrist problem will last for a long time
Agree
|
44 Participants
n=116 Participants
|
42 Participants
n=118 Participants
|
86 Participants
n=234 Participants
|
|
My hand or wrist problem will last for a long time
Strongly agree
|
14 Participants
n=116 Participants
|
12 Participants
n=118 Participants
|
26 Participants
n=234 Participants
|
|
My hand or wrist problem will last for a long time
Missing
|
3 Participants
n=116 Participants
|
2 Participants
n=118 Participants
|
5 Participants
n=234 Participants
|
|
My hand or wrist problem has major consequences on my life
Strongly disagree
|
4 Participants
n=116 Participants
|
10 Participants
n=118 Participants
|
14 Participants
n=234 Participants
|
|
My hand or wrist problem has major consequences on my life
Neither agree nor disagree
|
26 Participants
n=116 Participants
|
30 Participants
n=118 Participants
|
56 Participants
n=234 Participants
|
|
My hand or wrist problem has major consequences on my life
Agree
|
41 Participants
n=116 Participants
|
37 Participants
n=118 Participants
|
78 Participants
n=234 Participants
|
|
My hand or wrist problem has major consequences on my life
Strongly agree
|
23 Participants
n=116 Participants
|
17 Participants
n=118 Participants
|
40 Participants
n=234 Participants
|
|
My hand or wrist problem has major consequences on my life
Missing
|
3 Participants
n=116 Participants
|
2 Participants
n=118 Participants
|
5 Participants
n=234 Participants
|
|
There is a lot that I can do to control my hand or wrist problems
Strongly disagree
|
12 Participants
n=116 Participants
|
9 Participants
n=118 Participants
|
21 Participants
n=234 Participants
|
|
There is a lot that I can do to control my hand or wrist problems
Disagree
|
21 Participants
n=116 Participants
|
31 Participants
n=118 Participants
|
52 Participants
n=234 Participants
|
|
There is a lot that I can do to control my hand or wrist problems
Neither agree nor disagree
|
48 Participants
n=116 Participants
|
42 Participants
n=118 Participants
|
90 Participants
n=234 Participants
|
|
There is a lot that I can do to control my hand or wrist problems
Agree
|
30 Participants
n=116 Participants
|
32 Participants
n=118 Participants
|
62 Participants
n=234 Participants
|
|
There is a lot that I can do to control my hand or wrist problems
Strongly agree
|
2 Participants
n=116 Participants
|
2 Participants
n=118 Participants
|
4 Participants
n=234 Participants
|
|
There is a lot that I can do to control my hand or wrist problems
Missing
|
3 Participants
n=116 Participants
|
2 Participants
n=118 Participants
|
5 Participants
n=234 Participants
|
|
What I can do determines whether my hand or wrist problems gets better or worse
Strongly disagree
|
4 Participants
n=116 Participants
|
4 Participants
n=118 Participants
|
8 Participants
n=234 Participants
|
|
What I can do determines whether my hand or wrist problems gets better or worse
Disagree
|
11 Participants
n=116 Participants
|
14 Participants
n=118 Participants
|
25 Participants
n=234 Participants
|
|
What I can do determines whether my hand or wrist problems gets better or worse
Neither agree nor disagree
|
40 Participants
n=116 Participants
|
32 Participants
n=118 Participants
|
72 Participants
n=234 Participants
|
|
What I can do determines whether my hand or wrist problems gets better or worse
Agree
|
49 Participants
n=116 Participants
|
57 Participants
n=118 Participants
|
106 Participants
n=234 Participants
|
|
What I can do determines whether my hand or wrist problems gets better or worse
Strongly agree
|
9 Participants
n=116 Participants
|
9 Participants
n=118 Participants
|
18 Participants
n=234 Participants
|
|
What I can do determines whether my hand or wrist problems gets better or worse
Missing
|
3 Participants
n=116 Participants
|
2 Participants
n=118 Participants
|
5 Participants
n=234 Participants
|
|
Treatment can control my hand or wrist problem
Strongly disagree
|
0 Participants
n=116 Participants
|
0 Participants
n=118 Participants
|
0 Participants
n=234 Participants
|
|
Treatment can control my hand or wrist problem
Disagree
|
3 Participants
n=116 Participants
|
0 Participants
n=118 Participants
|
3 Participants
n=234 Participants
|
|
Treatment can control my hand or wrist problem
Neither agree nor disagree
|
20 Participants
n=116 Participants
|
35 Participants
n=118 Participants
|
55 Participants
n=234 Participants
|
|
Treatment can control my hand or wrist problem
Agree
|
74 Participants
n=116 Participants
|
71 Participants
n=118 Participants
|
145 Participants
n=234 Participants
|
|
Treatment can control my hand or wrist problem
Strongly agree
|
16 Participants
n=116 Participants
|
9 Participants
n=118 Participants
|
25 Participants
n=234 Participants
|
|
Treatment can control my hand or wrist problem
Missing
|
3 Participants
n=116 Participants
|
3 Participants
n=118 Participants
|
6 Participants
n=234 Participants
|
|
My hand or wrist problem affects me emotionally
Strongly disagree
|
10 Participants
n=116 Participants
|
18 Participants
n=118 Participants
|
28 Participants
n=234 Participants
|
|
My hand or wrist problem affects me emotionally
Disagree
|
17 Participants
n=116 Participants
|
19 Participants
n=118 Participants
|
36 Participants
n=234 Participants
|
|
My hand or wrist problem affects me emotionally
Neither agree nor disagree
|
17 Participants
n=116 Participants
|
21 Participants
n=118 Participants
|
38 Participants
n=234 Participants
|
|
My hand or wrist problem affects me emotionally
Agree
|
40 Participants
n=116 Participants
|
45 Participants
n=118 Participants
|
85 Participants
n=234 Participants
|
|
My hand or wrist problem affects me emotionally
Strongly agree
|
29 Participants
n=116 Participants
|
13 Participants
n=118 Participants
|
42 Participants
n=234 Participants
|
|
My hand or wrist problem affects me emotionally
Missing
|
3 Participants
n=116 Participants
|
2 Participants
n=118 Participants
|
5 Participants
n=234 Participants
|
|
Been bother by feeling down, depressed or hopeless
Yes
|
47 Participants
n=116 Participants
|
39 Participants
n=118 Participants
|
86 Participants
n=234 Participants
|
|
Been bother by feeling down, depressed or hopeless
No
|
66 Participants
n=116 Participants
|
78 Participants
n=118 Participants
|
144 Participants
n=234 Participants
|
|
Been bother by feeling down, depressed or hopeless
Missing
|
3 Participants
n=116 Participants
|
1 Participants
n=118 Participants
|
4 Participants
n=234 Participants
|
|
Been bothered by little interest or pleasure in doing things
Yes
|
39 Participants
n=116 Participants
|
33 Participants
n=118 Participants
|
72 Participants
n=234 Participants
|
|
Been bothered by little interest or pleasure in doing things
No
|
74 Participants
n=116 Participants
|
83 Participants
n=118 Participants
|
157 Participants
n=234 Participants
|
|
Been bothered by little interest or pleasure in doing things
Missing
|
3 Participants
n=116 Participants
|
2 Participants
n=118 Participants
|
5 Participants
n=234 Participants
|
|
Diagnosed with hypothyroidism
Yes
|
5 Participants
n=116 Participants
|
9 Participants
n=118 Participants
|
14 Participants
n=234 Participants
|
|
Diagnosed with hypothyroidism
No
|
108 Participants
n=116 Participants
|
107 Participants
n=118 Participants
|
215 Participants
n=234 Participants
|
|
Diagnosed with hypothyroidism
Missing
|
3 Participants
n=116 Participants
|
2 Participants
n=118 Participants
|
5 Participants
n=234 Participants
|
|
Diagnosed with diabetes
Yes
|
13 Participants
n=116 Participants
|
8 Participants
n=118 Participants
|
21 Participants
n=234 Participants
|
|
Diagnosed with diabetes
No
|
99 Participants
n=116 Participants
|
109 Participants
n=118 Participants
|
208 Participants
n=234 Participants
|
|
Diagnosed with diabetes
Missing
|
4 Participants
n=116 Participants
|
1 Participants
n=118 Participants
|
5 Participants
n=234 Participants
|
|
Any other conditions affecting neck, shoulders or elbows
Yes
|
45 Participants
n=116 Participants
|
28 Participants
n=118 Participants
|
73 Participants
n=234 Participants
|
|
Any other conditions affecting neck, shoulders or elbows
No
|
68 Participants
n=116 Participants
|
88 Participants
n=118 Participants
|
156 Participants
n=234 Participants
|
|
Any other conditions affecting neck, shoulders or elbows
Missing
|
3 Participants
n=116 Participants
|
2 Participants
n=118 Participants
|
5 Participants
n=234 Participants
|
|
Had pain anywhere else
Yes
|
74 Participants
n=116 Participants
|
72 Participants
n=118 Participants
|
146 Participants
n=234 Participants
|
|
Had pain anywhere else
No
|
39 Participants
n=116 Participants
|
45 Participants
n=118 Participants
|
84 Participants
n=234 Participants
|
|
Had pain anywhere else
Missing
|
3 Participants
n=116 Participants
|
1 Participants
n=118 Participants
|
4 Participants
n=234 Participants
|
|
Last time you were free of pain
<3 months ago
|
22 Participants
n=116 Participants
|
20 Participants
n=118 Participants
|
42 Participants
n=234 Participants
|
|
Last time you were free of pain
3-6 months ago
|
13 Participants
n=116 Participants
|
19 Participants
n=118 Participants
|
32 Participants
n=234 Participants
|
|
Last time you were free of pain
6 months-1 year ago
|
9 Participants
n=116 Participants
|
23 Participants
n=118 Participants
|
32 Participants
n=234 Participants
|
|
Last time you were free of pain
1-3 years ago
|
38 Participants
n=116 Participants
|
23 Participants
n=118 Participants
|
61 Participants
n=234 Participants
|
|
Last time you were free of pain
>3 years ago
|
31 Participants
n=116 Participants
|
32 Participants
n=118 Participants
|
63 Participants
n=234 Participants
|
|
Last time you were free of pain
Missing
|
3 Participants
n=116 Participants
|
1 Participants
n=118 Participants
|
4 Participants
n=234 Participants
|
|
On average, how often do you drink alcohol
Daily or most days
|
11 Participants
n=116 Participants
|
11 Participants
n=118 Participants
|
22 Participants
n=234 Participants
|
|
On average, how often do you drink alcohol
Once or twice a week
|
38 Participants
n=116 Participants
|
45 Participants
n=118 Participants
|
83 Participants
n=234 Participants
|
|
On average, how often do you drink alcohol
Once or twice a month
|
25 Participants
n=116 Participants
|
22 Participants
n=118 Participants
|
47 Participants
n=234 Participants
|
|
On average, how often do you drink alcohol
Once or twice a year
|
16 Participants
n=116 Participants
|
18 Participants
n=118 Participants
|
34 Participants
n=234 Participants
|
|
On average, how often do you drink alcohol
Never
|
23 Participants
n=116 Participants
|
21 Participants
n=118 Participants
|
44 Participants
n=234 Participants
|
|
On average, how often do you drink alcohol
Missing
|
3 Participants
n=116 Participants
|
1 Participants
n=118 Participants
|
4 Participants
n=234 Participants
|
|
What is your current smoking status
Never smoked
|
55 Participants
n=116 Participants
|
55 Participants
n=118 Participants
|
110 Participants
n=234 Participants
|
|
What is your current smoking status
Previously smoked
|
39 Participants
n=116 Participants
|
48 Participants
n=118 Participants
|
87 Participants
n=234 Participants
|
|
What is your current smoking status
Current smoker
|
19 Participants
n=116 Participants
|
13 Participants
n=118 Participants
|
32 Participants
n=234 Participants
|
|
What is your current smoking status
Missing
|
3 Participants
n=116 Participants
|
2 Participants
n=118 Participants
|
5 Participants
n=234 Participants
|
|
Has insomnia due to hand or wrist problem
No
|
46 Participants
n=116 Participants
|
58 Participants
n=118 Participants
|
104 Participants
n=234 Participants
|
|
Has insomnia due to hand or wrist problem
Yes
|
70 Participants
n=116 Participants
|
60 Participants
n=118 Participants
|
130 Participants
n=234 Participants
|
|
To what extent have hand or wrist problems affected your performance at work over the past month
|
3.8 units on a scale
STANDARD_DEVIATION 3.0 • n=116 Participants
|
4.2 units on a scale
STANDARD_DEVIATION 2.9 • n=118 Participants
|
4.0 units on a scale
STANDARD_DEVIATION 3.0 • n=234 Participants
|
|
Body mass index
|
30.2 kg/m2
STANDARD_DEVIATION 7.6 • n=116 Participants
|
30.5 kg/m2
STANDARD_DEVIATION 7.5 • n=118 Participants
|
30.4 kg/m2
STANDARD_DEVIATION 7.6 • n=234 Participants
|
|
Boston carpal tunnel symptom severity and functional limitations
|
2.69 units on a scale
STANDARD_DEVIATION 0.70 • n=116 Participants
|
2.65 units on a scale
STANDARD_DEVIATION 0.62 • n=118 Participants
|
2.67 units on a scale
STANDARD_DEVIATION 0.66 • n=234 Participants
|
|
Boston carpal tunnel symptom severity subscale
|
2.96 units on a scale
STANDARD_DEVIATION 0.66 • n=116 Participants
|
2.91 units on a scale
STANDARD_DEVIATION 0.61 • n=118 Participants
|
2.94 units on a scale
STANDARD_DEVIATION 0.63 • n=234 Participants
|
|
Boston carpal tunnel functional limitations subscale
|
2.32 units on a scale
STANDARD_DEVIATION 0.92 • n=116 Participants
|
2.28 units on a scale
STANDARD_DEVIATION 0.84 • n=118 Participants
|
2.30 units on a scale
STANDARD_DEVIATION 0.88 • n=234 Participants
|
|
Hand-wrist pain intensity
|
6.33 units on a scale
STANDARD_DEVIATION 2.05 • n=116 Participants
|
6.12 units on a scale
STANDARD_DEVIATION 2.21 • n=118 Participants
|
6.23 units on a scale
STANDARD_DEVIATION 2.13 • n=234 Participants
|
PRIMARY outcome
Timeframe: 6 weeksComparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire
Outcome measures
| Measure |
Steroid Injection
n=116 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=118 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
Symptom Severity and Limitations in Hand Function as Assessed by the BCTQ 6 Weeks
|
2.02 score on a scale
Standard Deviation 0.81
|
2.29 score on a scale
Standard Deviation 0.75
|
SECONDARY outcome
Timeframe: 6 weeksComparison of BCTQ symptom severity between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms). BCTQ: Boston Carpal Tunnel Questionnaire
Outcome measures
| Measure |
Steroid Injection
n=116 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=118 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
BCTQ Symptom Severity Subscale 6 Weeks
|
2.12 score on a scale
Standard Deviation 0.84
|
2.43 score on a scale
Standard Deviation 0.76
|
SECONDARY outcome
Timeframe: 6 weeksComparison of BCTQ functional limitations between treatment groups at 6 weeks follow-up (1-5 scale, higher score indicates more severe functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire
Outcome measures
| Measure |
Steroid Injection
n=116 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=118 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
BCTQ Functional Limitations Subscale 6 Weeks
|
1.88 score on a scale
Standard Deviation 0.88
|
2.09 score on a scale
Standard Deviation 0.86
|
SECONDARY outcome
Timeframe: 6 weeksComparison of pain scores between treatment groups at 6 weeks follow-up (0-10 scale, higher score indicates more pain).
Outcome measures
| Measure |
Steroid Injection
n=116 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=118 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
Hand-wrist Pain Intensity 6 Weeks
|
3.42 units on a scale
Standard Deviation 2.77
|
4.28 units on a scale
Standard Deviation 2.73
|
SECONDARY outcome
Timeframe: 6 weeksParticipants were asked four questions how hand and wrist problems affects their sleep. Participants reporting hand and wrist problems affects their sleep on most nights on one or more questions were deemed to have insomnia.
Outcome measures
| Measure |
Steroid Injection
n=116 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=118 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
Insomnia Due to Hand-wrist Problems 6 Weeks
No
|
83 Participants
|
73 Participants
|
|
Insomnia Due to Hand-wrist Problems 6 Weeks
Yes
|
33 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: 6 weeksParticipants were asked if they were referred for surgery (carpal tunnel decompression) in the last 6 weeks. Multiple imputation for missing data was performed at 6 weeks. Comparison of outcome between treatment arms planned to adjust for sex, age, and duration of symptoms. Logistic regression was not performed due to small number of 'yes' counts.
Outcome measures
| Measure |
Steroid Injection
n=116 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=118 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
Referral for Surgery 6 Weeks
No
|
112 Participants
|
113 Participants
|
|
Referral for Surgery 6 Weeks
Yes
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 6 weeksParticipants were asked if they had surgery for carpal tunnel syndrome in the last 6 weeks. Multiple imputation for missing data was performed at 6 weeks. Comparison of outcome between treatment arms planned to adjust for sex, age, and duration of symptoms. Logistic regression was not performed due to small number of 'yes' counts.
Outcome measures
| Measure |
Steroid Injection
n=116 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=118 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
Surgery 6 Weeks
No
|
114 Participants
|
116 Participants
|
|
Surgery 6 Weeks
Yes
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 monthsComparison of overall BCTQ between treatment groups at 6 months follow-up (1-5 scale, higher score indicates more severe symptoms and functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire
Outcome measures
| Measure |
Steroid Injection
n=116 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=118 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
BCTQ Symptom Severity and Functional Limitations 6 Months
|
2.15 score on a scale
Standard Deviation 0.79
|
2.06 score on a scale
Standard Deviation 0.73
|
SECONDARY outcome
Timeframe: 6 monthsComparison of BCTQ symptom severity between treatment groups at 6 months follow-up (1-5 scale, higher score indicates more severe symptoms). BCTQ: Boston Carpal Tunnel Questionnaire
Outcome measures
| Measure |
Steroid Injection
n=116 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=118 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
BCTQ Symptom Severity Subscale 6 Months
|
2.33 score on a scale
Standard Deviation 0.86
|
2.18 score on a scale
Standard Deviation 0.75
|
SECONDARY outcome
Timeframe: 6 monthsComparison of BCTQ functional limitations between treatment groups at 6 months follow-up (1-5 scale, higher score indicates more functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire
Outcome measures
| Measure |
Steroid Injection
n=116 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=118 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
BCTQ Functional Limitations Subscale 6 Months
|
1.91 score on a scale
Standard Deviation 0.84
|
1.89 score on a scale
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: 6 monthsComparison of pain scores between treatment groups at 6 months follow-up. 0-10 scale, higher score indicates more pain.
Outcome measures
| Measure |
Steroid Injection
n=116 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=118 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
Hand-wrist Pain Intensity 6 Months
|
4.32 units on a scale
Standard Deviation 3.26
|
3.46 units on a scale
Standard Deviation 3.01
|
SECONDARY outcome
Timeframe: 6 monthsParticipants were asked four questions how hand and wrist problems affects their sleep. Participants reporting hand and wrist problems affects their sleep on most nights on one or more questions were deemed to have insomnia.
Outcome measures
| Measure |
Steroid Injection
n=116 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=118 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
Insomnia Due to Hand-wrist Problems 6 Months
No
|
79 Participants
|
86 Participants
|
|
Insomnia Due to Hand-wrist Problems 6 Months
Yes
|
37 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: 6 monthsParticipants were asked if they were referred for surgery (carpal tunnel decompression) in the last 6 months.
Outcome measures
| Measure |
Steroid Injection
n=116 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=118 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
Referral to Surgery 6 Months
No
|
94 Participants
|
104 Participants
|
|
Referral to Surgery 6 Months
Yes
|
22 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 6 monthsParticipants were asked if they had surgery for carpal tunnel syndrome in the last 6 months.
Outcome measures
| Measure |
Steroid Injection
n=116 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=118 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
Surgery 6 Months
No
|
99 Participants
|
105 Participants
|
|
Surgery 6 Months
Yes
|
17 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 6 monthsParticipants were asked if they had bought herbal remedies or vitamins to help with hand or wrist problems in the last 6 months
Outcome measures
| Measure |
Steroid Injection
n=116 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=118 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
Herbal Remedies and Vitamin Use 6 Months
No
|
109 Participants
|
111 Participants
|
|
Herbal Remedies and Vitamin Use 6 Months
Yes
|
7 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 6 monthsParticipants were asked if they bought over the counter paracetamol, ibuprofen or co-codamol to help with hand or wrist problems in the last 6 months.
Outcome measures
| Measure |
Steroid Injection
n=116 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=118 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
Over the Counter Pain Medication 6 Months
No
|
82 Participants
|
88 Participants
|
|
Over the Counter Pain Medication 6 Months
Yes
|
34 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: 6 monthsParticipants were asked if they were prescribed tablet medication (paracetamol, ibuprofen, naproxen, diclofenac, codeine, tramadol, co-codomal, tramacet, co-proxamol, dihydrocodeine, other) for hand or wrist problem in the last 6 months.
Outcome measures
| Measure |
Steroid Injection
n=116 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=118 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
Prescribed Pain Medication 6 Months
No
|
96 Participants
|
106 Participants
|
|
Prescribed Pain Medication 6 Months
Yes
|
20 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 6 weeksComparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 1-5, higher score indicates more severe symptoms and functional impairment. Results are presented at 6 weeks. BCTQ: Boston Carpal Tunnel Questionnaire
Outcome measures
| Measure |
Steroid Injection
n=95 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=102 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Weeks
|
1.95 score on a scale
Standard Deviation 0.82
|
2.30 score on a scale
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: 6 monthsComparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up. Scale 1-5, higher score indicates more severe symptoms and functional impairment. Results are presented at 6 months. BCTQ: Boston Carpal Tunnel Questionnaire.
Outcome measures
| Measure |
Steroid Injection
n=83 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=92 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Months
|
2.08 score on a scale
Standard Deviation 0.79
|
2.04 score on a scale
Standard Deviation 0.72
|
SECONDARY outcome
Timeframe: 12 monthsComparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 1-5, higher score indicates more severe symptoms and functional impairment). Results are presented at 12 months. BCTQ: Boston Carpal Tunnel Questionnaire.
Outcome measures
| Measure |
Steroid Injection
n=78 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=78 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
BCTQ Symptom Severity and Functional Limitations Over 24 Months: 12 Months
|
1.98 score on a scale
Standard Deviation 0.88
|
2.05 score on a scale
Standard Deviation 0.80
|
SECONDARY outcome
Timeframe: 24 monthsComparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 1-5, higher score indicates more severe symptoms and functional impairment. Results are presented at 24 months. BCTQ: Boston Carpal Tunnel Questionnaire
Outcome measures
| Measure |
Steroid Injection
n=70 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=73 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
Secondary: BCTQ Symptom Severity and Functional Limitations Over 24 Months: 24 Months
|
1.79 score on a scale
Standard Deviation 0.79
|
1.73 score on a scale
Standard Deviation 0.76
|
SECONDARY outcome
Timeframe: 6 weeksComparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 6 weeks.
Outcome measures
| Measure |
Steroid Injection
n=105 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=106 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
Hand-wrist Pain Intensity Over 24 Months: 6 Weeks
|
3.33 score on a scale
Standard Deviation 2.67
|
4.28 score on a scale
Standard Deviation 2.62
|
SECONDARY outcome
Timeframe: 6 monthsComparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 6 months.
Outcome measures
| Measure |
Steroid Injection
n=92 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=94 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
Hand-wrist Pain Intensity Over 24 Months: 6 Months
|
4.11 score on a scale
Standard Deviation 3.01
|
3.29 score on a scale
Standard Deviation 2.74
|
SECONDARY outcome
Timeframe: 12 monthsComparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 12 months.
Outcome measures
| Measure |
Steroid Injection
n=83 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=85 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
Hand-wrist Pain Intensity Over 24 Months: 12 Months
|
3.17 score on a scale
Standard Deviation 2.93
|
3.14 score on a scale
Standard Deviation 2.74
|
SECONDARY outcome
Timeframe: 24 monthsComparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 24 months.
Outcome measures
| Measure |
Steroid Injection
n=75 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=77 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
Hand-wrist Pain Intensity Over 24 Months: 24 Months
|
2.81 score on a scale
Standard Deviation 3.19
|
2.40 score on a scale
Standard Deviation 2.83
|
SECONDARY outcome
Timeframe: 6 weeksSensitivity analysis for comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Outcome measures
| Measure |
Steroid Injection
n=95 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=102 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
BCTQ Symptom Severity and Functional Limitations 6 Weeks (Complete Case Analysis (CC))
|
1.95 score on a scale
Standard Deviation 0.82
|
2.29 score on a scale
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: 6 weeksSensitivity analysis for comparison of BCTQ symptom severity between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Outcome measures
| Measure |
Steroid Injection
n=104 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=104 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
BCTQ Symptom Severity Subscale 6 Weeks (CC)
|
2.07 score on a scale
Standard Deviation 0.83
|
2.44 score on a scale
Standard Deviation 0.78
|
SECONDARY outcome
Timeframe: 6 weeksSensitivity analysis for comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Outcome measures
| Measure |
Steroid Injection
n=96 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=105 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
BCTQ Functional Limitations Subscale 6 Weeks (CC)
|
1.86 score on a scale
Standard Deviation 0.91
|
2.10 score on a scale
Standard Deviation 0.86
|
SECONDARY outcome
Timeframe: 6 weeksSensitivity analysis for comparison of pain scores between treatment groups at 6 weeks follow-up (scale 0-10, higher score indicates more pain) on participants with complete data.
Outcome measures
| Measure |
Steroid Injection
n=105 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=106 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
Hand-wrist Pain Intensity 6 Weeks (CC)
|
3.33 score on a scale
Standard Deviation 2.67
|
4.28 score on a scale
Standard Deviation 2.62
|
SECONDARY outcome
Timeframe: 6 weeksParticipants were asked four questions how hand and wrist problems affects their sleep. Participants reporting hand and wrist problems affects their sleep on most nights on one or more questions were deemed to have insomnia. Sensitivity analysis for comparison of the odds of insomnia between treatment groups at 6 weeks follow-up on participants with complete data.
Outcome measures
| Measure |
Steroid Injection
n=97 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=96 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
Insomnia Due to Hand-wrist Problems 6 Weeks (CC)
Yes
|
22 Participants
|
34 Participants
|
|
Insomnia Due to Hand-wrist Problems 6 Weeks (CC)
No
|
75 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: 6 monthsSensitivity analysis for comparison of overall BCTQ between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Outcome measures
| Measure |
Steroid Injection
n=83 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=92 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
BCTQ Symptom Severity and Functional Limitations 6 Months (CC)
|
2.08 score on a scale
Standard Deviation 0.79
|
2.04 score on a scale
Standard Deviation 0.72
|
SECONDARY outcome
Timeframe: 6 monthsSensitivity analysis for comparison of BCTQ symptom severity between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Outcome measures
| Measure |
Steroid Injection
n=88 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=94 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
BCTQ Symptom Severity Subscale 6 Months (CC)
|
2.29 score on a scale
Standard Deviation 0.87
|
2.16 score on a scale
Standard Deviation 0.74
|
SECONDARY outcome
Timeframe: 6 monthsSensitivity analysis for comparison of BCTQ function limitations between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Outcome measures
| Measure |
Steroid Injection
n=85 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=93 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
BCTQ Functional Limitations Subscale 6 Months (CC)
|
1.85 score on a scale
Standard Deviation 0.84
|
1.88 score on a scale
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: 6 monthsSensitivity analysis for comparison of pain scores between treatment groups at 6 months follow-up (scale 0-10, higher score indicates more pain) on participants with complete data.
Outcome measures
| Measure |
Steroid Injection
n=92 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=94 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
Hand-wrist Pain Intensity 6 Months (CC)
|
4.11 score on a scale
Standard Deviation 3.01
|
3.29 score on a scale
Standard Deviation 2.74
|
SECONDARY outcome
Timeframe: 6 monthsParticipants were asked four questions how hand and wrist problems affects their sleep. Participants reporting hand and wrist problems affects their sleep on most nights on one or more questions were deemed to have insomnia. Sensitivity analysis for comparison of the odds of insomnia between treatment groups at 6 months follow-up on participants with complete data.
Outcome measures
| Measure |
Steroid Injection
n=80 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=86 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
Insomnia Due to Hand-wrist Problems 6 Months (CC)
No
|
60 Participants
|
68 Participants
|
|
Insomnia Due to Hand-wrist Problems 6 Months (CC)
Yes
|
20 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 6 monthsParticipants were asked if they were referred for surgery (carpal tunnel decompression) in the last 6 months. Sensitivity analysis for comparison of the odds of insomnia between treatment groups at 6 months follow-up on participants with complete data.
Outcome measures
| Measure |
Steroid Injection
n=96 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=93 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
Referral to Surgery 6 Months (CC)
No
|
80 Participants
|
82 Participants
|
|
Referral to Surgery 6 Months (CC)
Yes
|
16 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 6 monthsParticipants were asked if they had bought herbal remedies or vitamins to help with hand or wrist problems in the last 6 months. Sensitivity analysis for comparison of the odds of herbal remedies and vitamin use between treatment groups at 6 months follow-up on participants with complete data. Complete case analysis as a sensitivity analysis was planned. Comparison of outcome between treatment arms planned to adjust for sex, age, and duration of symptoms. Logistic regression was not performed due to small number of 'yes' counts.
Outcome measures
| Measure |
Steroid Injection
n=80 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=83 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
Herbal Remedies and Vitamin Use 6 Months (CC)
No
|
78 Participants
|
81 Participants
|
|
Herbal Remedies and Vitamin Use 6 Months (CC)
Yes
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 monthsParticipants were asked if they bought over the counter paracetamol, ibuprofen or co-codamol to help with hand or wrist problems in the last 6 months. Sensitivity analysis for comparison of the odds of medication use between treatment groups at 6 months follow-up on participants with complete data.
Outcome measures
| Measure |
Steroid Injection
n=80 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=83 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
Over the Counter Pain Medication 6 Months (CC)
No
|
64 Participants
|
66 Participants
|
|
Over the Counter Pain Medication 6 Months (CC)
Yes
|
16 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 6 monthsParticipants were asked if they were prescribed tablet medication (paracetamol, ibuprofen, naproxen, diclofenac, codeine, tramadol, co-codomal, tramacet, co-proxamol, dihydrocodeine, other) for hand or wrist problem in the last 6 months. Sensitivity analysis for comparison of the odds of pain medication use between treatment groups at 6 months follow-up on participants with complete data.
Outcome measures
| Measure |
Steroid Injection
n=82 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=86 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
Prescribed Pain Medication 6 Months (CC)
No
|
70 Participants
|
79 Participants
|
|
Prescribed Pain Medication 6 Months (CC)
Yes
|
12 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 6 weeksPer protocol analysis for comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Outcome measures
| Measure |
Steroid Injection
n=94 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=85 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
BCTQ Symptom Severity and Functional Limitations 6 Weeks (Per-Protocol Analysis (PP))
|
1.96 score on a scale
Standard Deviation 0.84
|
2.28 score on a scale
Standard Deviation 0.72
|
SECONDARY outcome
Timeframe: 6 weeksPer protocol analysis for comparison of BCTQ symptom severity between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Outcome measures
| Measure |
Steroid Injection
n=102 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=86 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
BCTQ Symptom Severity Subscale 6 Weeks (PP)
|
2.07 score on a scale
Standard Deviation 0.83
|
2.44 score on a scale
Standard Deviation 0.74
|
SECONDARY outcome
Timeframe: 6 weeksPer protocol analysis for comparison of BCTQ functional limitations between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Outcome measures
| Measure |
Steroid Injection
n=95 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=87 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
BCTQ Functional Limitations Subscale 6 Weeks (PP)
|
1.88 score on a scale
Standard Deviation 0.94
|
2.06 score on a scale
Standard Deviation 0.80
|
SECONDARY outcome
Timeframe: 6 weeksPer protocol analysis for comparison of pain scores between treatment groups at 6 weeks follow-up (higher score indicates more pain) on participants with complete data.
Outcome measures
| Measure |
Steroid Injection
n=103 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=87 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
Hand-wrist Pain Intensity 6 Weeks (PP)
|
3.33 score on a scale
Standard Deviation 2.67
|
4.44 score on a scale
Standard Deviation 2.50
|
SECONDARY outcome
Timeframe: 6 weeksParticipants were asked four questions how hand and wrist problems affects their sleep. Participants reporting hand and wrist problems affects their sleep on most nights on one or more questions were deemed to have insomnia. Per protocol analysis for comparison of the odds of insomnia between treatment groups at 6 weeks follow-up on participants with complete data.
Outcome measures
| Measure |
Steroid Injection
n=95 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=87 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
Insomnia Due to Hand-wrist Problems 6 Weeks (PP)
No
|
74 Participants
|
57 Participants
|
|
Insomnia Due to Hand-wrist Problems 6 Weeks (PP)
Yes
|
21 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPer protocol analysis for comparison of overall BCTQ between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Outcome measures
| Measure |
Steroid Injection
n=83 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=76 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
BCTQ Symptom Severity and Functional Limitations 6 Months (PP)
|
2.09 score on a scale
Standard Deviation 0.79
|
2.02 score on a scale
Standard Deviation 0.69
|
SECONDARY outcome
Timeframe: 6 monthsPer protocol analysis for comparison of BCTQ symptom severity between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Outcome measures
| Measure |
Steroid Injection
n=88 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=78 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
BCTQ Symptom Severity Subscale 6 Months (PP)
|
2.28 score on a scale
Standard Deviation 0.86
|
2.15 score on a scale
Standard Deviation 0.73
|
SECONDARY outcome
Timeframe: 6 monthsPer protocol analysis for comparison of BCTQ functional limitations between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Outcome measures
| Measure |
Steroid Injection
n=85 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=77 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
BCTQ Functional Limitations Subscale 6 Months (PP)
|
1.89 score on a scale
Standard Deviation 0.87
|
1.84 score on a scale
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: 6 monthsPer protocol analysis for comparison of pain scores between treatment groups at 6 months follow-up (scale 0-10, higher score indicates more pain) on participants with complete data.
Outcome measures
| Measure |
Steroid Injection
n=92 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=78 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
Hand-wrist Pain Intensity 6 Months (PP)
|
4.11 score on a scale
Standard Deviation 2.99
|
3.38 score on a scale
Standard Deviation 2.79
|
SECONDARY outcome
Timeframe: 6 monthsParticipants were asked four questions how hand and wrist problems affects their sleep. Participants reporting hand and wrist problems affects their sleep on most nights on one or more questions were deemed to have insomnia. Per protocol analysis for comparison of the odds of insomnia between treatment groups at 6 months follow-up on participants with complete data.
Outcome measures
| Measure |
Steroid Injection
n=81 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=75 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
Insomnia Due to Hand-wrist Problems 6 Months (PP)
No
|
61 Participants
|
59 Participants
|
|
Insomnia Due to Hand-wrist Problems 6 Months (PP)
Yes
|
20 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 6 monthsParticipants were asked if they were referred for surgery (carpal tunnel decompression) in the last 6 months. Per protocol analysis for comparison of the odds of surgery between treatment groups at 6 months follow-up on participants with complete data.
Outcome measures
| Measure |
Steroid Injection
n=94 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=85 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
Referral to Surgery at 6 Months (PP)
No
|
78 Participants
|
74 Participants
|
|
Referral to Surgery at 6 Months (PP)
Yes
|
16 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 6 monthsParticipants were asked if they had bought herbal remedies or vitamins to help with hand or wrist problems in the last 6 months. Per protocol analysis for comparison of the odds of herbal remedies and vitamin use between treatment groups at 6 months follow-up on participants with complete data. Per protocol analysis on complete date was planned. Comparison of outcome between treatment arms planned to adjust for sex, age, and duration of symptoms. Logistic regression was not performed due to small number of 'yes' counts.
Outcome measures
| Measure |
Steroid Injection
n=81 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=73 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
Herbal Remedies and Vitamin Use 6 Months (PP)
No
|
78 Participants
|
72 Participants
|
|
Herbal Remedies and Vitamin Use 6 Months (PP)
Yes
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 monthsParticipants were asked if they bought over the counter paracetamol, ibuprofen or co-codamol to help with hand or wrist problems in the last 6 months. Per protocol analysis for comparison of the odds of medication use between treatment groups at 6 months follow-up on participants with complete data
Outcome measures
| Measure |
Steroid Injection
n=81 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=73 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
Over the Counter Pain Medication 6 Months (PP)
No
|
65 Participants
|
58 Participants
|
|
Over the Counter Pain Medication 6 Months (PP)
Yes
|
16 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 6 monthsParticipants were asked if they were prescribed tablet medication (paracetamol, ibuprofen, naproxen, diclofenac, codeine, tramadol, co-codomal, tramacet, co-proxamol, dihydrocodeine, other) for hand or wrist problem in the last 6 months. Per protocol analysis for comparison of the odds of medication use between treatment groups at 6 months follow-up on participants with complete data.
Outcome measures
| Measure |
Steroid Injection
n=83 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=76 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
Prescribed Pain Medication 6 Months (PP)
No
|
70 Participants
|
70 Participants
|
|
Prescribed Pain Medication 6 Months (PP)
Yes
|
13 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 6 weeksSubgroup analysis was performed in patients who were allocated the intervention of their preference. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Outcome measures
| Measure |
Steroid Injection
n=24 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=18 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
BCTQ Symptom Severity and Functional Limitations 6 Weeks (Subgroup Analysis (SG), Intervention of Their Preference)
|
1.88 score on a scale
Standard Deviation 0.76
|
2.19 score on a scale
Standard Deviation 0.75
|
SECONDARY outcome
Timeframe: 6 weeksSubgroup analysis was performed in patients who did not receive the intervention of their preference. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Outcome measures
| Measure |
Steroid Injection
n=18 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=34 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Did Not Receive the Intervention of Their Preference)
|
2.15 score on a scale
Standard Deviation 0.91
|
2.40 score on a scale
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: 6 weeksSubgroup analysis was performed in patients who did not state a preference of intervention. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Outcome measures
| Measure |
Steroid Injection
n=67 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=61 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Did Not State a Preference of Intervention)
|
2.03 score on a scale
Standard Deviation 0.79
|
2.26 score on a scale
Standard Deviation 0.69
|
SECONDARY outcome
Timeframe: 6 weeksSubgroup analysis was performed in patients who preferred injection. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Outcome measures
| Measure |
Steroid Injection
n=24 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=34 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Preferred Injection)
|
1.88 score on a scale
Standard Deviation 0.76
|
2.40 score on a scale
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: 6 weeksSubgroup analysis was performed in patients who preferred splint. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Outcome measures
| Measure |
Steroid Injection
n=18 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=34 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Preferred Splint)
|
2.15 score on a scale
Standard Deviation 0.91
|
2.40 score on a scale
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: 6 monthsCost of interventions at 6 months
Outcome measures
| Measure |
Steroid Injection
n=116 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=118 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
NHS Cost Differences at 6 Months
|
346.78 UK Pounds
Standard Deviation 467.97
|
313.24 UK Pounds
Standard Deviation 480.84
|
SECONDARY outcome
Timeframe: 6 monthsComplete case analysis on the cost of interventions at 6 months
Outcome measures
| Measure |
Steroid Injection
n=116 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=118 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
NHS Cost Differences at 6 Months (CC)
|
353.48 UK Pounds
Standard Deviation 512.85
|
306.42 UK Pounds
Standard Deviation 524.51
|
SECONDARY outcome
Timeframe: 12 monthsCost of interventions at 12 months
Outcome measures
| Measure |
Steroid Injection
n=116 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=118 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
NHS Cost Differences at 12 Months
|
508.69 UK Pounds
Standard Deviation 657.48
|
395.54 UK Pounds
Standard Deviation 596.47
|
SECONDARY outcome
Timeframe: 24 monthsCost of interventions at 24 months
Outcome measures
| Measure |
Steroid Injection
n=116 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=118 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
NHS Cost Differences at 24 Months
|
657.87 UK Pounds
Standard Deviation 808.57
|
586.77 UK Pounds
Standard Deviation 783.45
|
SECONDARY outcome
Timeframe: 6 monthsThe Quality Adjusted Life Years (QALYs) is a measure of the state of health of a person/group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health. QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment/intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale). It is often measured in terms of the person's ability to carry out the activities of daily life and freedom from pain and mental disturbance. The QALY does not have a maximum score. Cross-walk tariff: Crosswalk value sets were developed from a study of respondents who completed both the EQ-5D-3L and EQ-5D-5L. The crosswalk used a non-parametric response mapping method to predict values that are linked to the EQ-5D-3L value set. In short, the cross-walk tariff maps EQ-5D-5L values.
Outcome measures
| Measure |
Steroid Injection
n=116 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=118 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
QALYS at 6 Months (Cross-walk Tariff)
|
0.354 score on a scale
Standard Deviation 0.093
|
0.356 score on a scale
Standard Deviation 0.087
|
SECONDARY outcome
Timeframe: 12 monthsThe Quality Adjusted Life Years (QALYs) is a measure of the state of health of a person/group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health. QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment/intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale). It is often measured in terms of the person's ability to carry out the activities of daily life and freedom from pain and mental disturbance. The QALY does not have a maximum score. Cross-walk tariff: Crosswalk value sets were developed from a study of respondents who completed both the EQ-5D-3L and EQ-5D-5L. The crosswalk used a non-parametric response mapping method to predict values that are linked to the EQ-5D-3L value set. In short, the cross-walk tariff maps EQ-5D-5L values.
Outcome measures
| Measure |
Steroid Injection
n=116 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=118 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
QALYS at 12 Months (Cross-walk Tariff)
|
0.723 score on a scale
Standard Deviation 0.163
|
0.736 score on a scale
Standard Deviation 0.156
|
SECONDARY outcome
Timeframe: 24 monthsThe Quality Adjusted Life Years (QALYs) is a measure of the state of health of a person/group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health. QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment/intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale). It is often measured in terms of the person's ability to carry out the activities of daily life and freedom from pain and mental disturbance. The QALY does not have a maximum score. Cross-walk tariff: Crosswalk value sets were developed from a study of respondents who completed both the EQ-5D-3L and EQ-5D-5L. The crosswalk used a non-parametric response mapping method to predict values that are linked to the EQ-5D-3L value set. In short, the cross-walk tariff maps EQ-5D-5L values.
Outcome measures
| Measure |
Steroid Injection
n=116 Participants
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=118 Participants
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
QALYS at 24 Months (Cross-walk Tariff)
|
1.461 score on a scale
Standard Deviation 0.311
|
1.497 score on a scale
Standard Deviation 0.301
|
Adverse Events
Steroid Injection
Wrist Splint
Serious adverse events
| Measure |
Steroid Injection
n=116 participants at risk
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=118 participants at risk
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/116 • 24 months
Reporting by investigators. Expected related adverse events self-reported by participants in 6-week questionnaire.
|
0.85%
1/118 • Number of events 1 • 24 months
Reporting by investigators. Expected related adverse events self-reported by participants in 6-week questionnaire.
|
|
Cardiac disorders
Other
|
0.86%
1/116 • Number of events 1 • 24 months
Reporting by investigators. Expected related adverse events self-reported by participants in 6-week questionnaire.
|
0.00%
0/118 • 24 months
Reporting by investigators. Expected related adverse events self-reported by participants in 6-week questionnaire.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/116 • 24 months
Reporting by investigators. Expected related adverse events self-reported by participants in 6-week questionnaire.
|
0.85%
1/118 • Number of events 1 • 24 months
Reporting by investigators. Expected related adverse events self-reported by participants in 6-week questionnaire.
|
|
Respiratory, thoracic and mediastinal disorders
Other
|
0.86%
1/116 • Number of events 1 • 24 months
Reporting by investigators. Expected related adverse events self-reported by participants in 6-week questionnaire.
|
0.00%
0/118 • 24 months
Reporting by investigators. Expected related adverse events self-reported by participants in 6-week questionnaire.
|
|
Musculoskeletal and connective tissue disorders
Other
|
0.86%
1/116 • Number of events 1 • 24 months
Reporting by investigators. Expected related adverse events self-reported by participants in 6-week questionnaire.
|
0.00%
0/118 • 24 months
Reporting by investigators. Expected related adverse events self-reported by participants in 6-week questionnaire.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/116 • 24 months
Reporting by investigators. Expected related adverse events self-reported by participants in 6-week questionnaire.
|
1.7%
2/118 • Number of events 2 • 24 months
Reporting by investigators. Expected related adverse events self-reported by participants in 6-week questionnaire.
|
Other adverse events
| Measure |
Steroid Injection
n=116 participants at risk
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection
|
Wrist Splint
n=118 participants at risk
Wrist splint to be worn at night
Wrist Splint: Simple wrist splint
|
|---|---|---|
|
Vascular disorders
Flushing
|
14.7%
17/116 • Number of events 17 • 24 months
Reporting by investigators. Expected related adverse events self-reported by participants in 6-week questionnaire.
|
0.00%
0/118 • 24 months
Reporting by investigators. Expected related adverse events self-reported by participants in 6-week questionnaire.
|
|
Skin and subcutaneous tissue disorders
Other
|
3.4%
4/116 • Number of events 4 • 24 months
Reporting by investigators. Expected related adverse events self-reported by participants in 6-week questionnaire.
|
0.00%
0/118 • 24 months
Reporting by investigators. Expected related adverse events self-reported by participants in 6-week questionnaire.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
45.7%
53/116 • Number of events 53 • 24 months
Reporting by investigators. Expected related adverse events self-reported by participants in 6-week questionnaire.
|
5.9%
7/118 • Number of events 7 • 24 months
Reporting by investigators. Expected related adverse events self-reported by participants in 6-week questionnaire.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place