Trial Outcomes & Findings for Local Steroid Injection vs Placebo in Carpal Tunnel Syndrome (NCT NCT02652390)
NCT ID: NCT02652390
Last Updated: 2018-10-22
Results Overview
Number of patients who have had carpal tunnel release surgery on the study hand.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
111 participants
Primary outcome timeframe
5 to 7 years
Results posted on
2018-10-22
Participant Flow
This is a long-term follow-up of patients who participated in a randomized trial. In the initial trial the patients were recruited between November 7, 1998 and March 10, 2011 (NCT00806871; see Atroshi et al. Ann Intern Med 2013). Data in this follow-up were collected between February 24, 2016 and July 7, 2016.
No significant events occurred after participant enrollment but prior to assignment to arms.
Participant milestones
| Measure |
Methylprednisolone 80 mg
Local injection of 80 mg Methylprednisolone into the carpal tunnel
Methylprednisolone 80 mg: 2 mL methylprednisolone (40 mg/mL) + 1 mL lidocaine
|
Methylprednisolone 40 mg
Local injection of 40 mg Methylprednisolone into the carpal tunnel
Methylprednisolone 40 mg: 1 mL methylprednisolone (40 mg/mL) + 1 mL saline + 1 mL lidocaine
|
Placebo
Local injection of saline into the carpal tunnel
Saline: 2 mL saline + 1 mL lidocaine
|
|---|---|---|---|
|
Overall Study
STARTED
|
37
|
37
|
37
|
|
Overall Study
COMPLETED
|
37
|
37
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Local Steroid Injection vs Placebo in Carpal Tunnel Syndrome
Baseline characteristics by cohort
| Measure |
Methylprednisolone 80 mg
n=37 Participants
Local injection of 80 mg Methylprednisolone into the carpal tunnel
Methylprednisolone 80 mg: 2 mL methylprednisolone (40 mg/mL) + 1 mL lidocaine
|
Methylprednisolone 40 mg
n=37 Participants
Local injection of 40 mg Methylprednisolone into the carpal tunnel
Methylprednisolone 40 mg: 1 mL methylprednisolone (40 mg/mL) + 1 mL saline + 1 mL lidocaine
|
Placebo
n=37 Participants
Local injection of saline into the carpal tunnel
Saline: 2 mL saline + 1 mL lidocaine
|
Total
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 12 • n=5 Participants
|
50 years
STANDARD_DEVIATION 11 • n=7 Participants
|
55 years
STANDARD_DEVIATION 12 • n=5 Participants
|
53 years
STANDARD_DEVIATION 12 • n=4 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
111 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Sweden
|
37 participants
n=5 Participants
|
37 participants
n=7 Participants
|
37 participants
n=5 Participants
|
111 participants
n=4 Participants
|
|
Dominant hand treated
|
30 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
|
Body mass index
|
27.3 kg/m2
STANDARD_DEVIATION 4.2 • n=5 Participants
|
27.6 kg/m2
STANDARD_DEVIATION 4.3 • n=7 Participants
|
27.7 kg/m2
STANDARD_DEVIATION 5.7 • n=5 Participants
|
27.5 kg/m2
STANDARD_DEVIATION 4.8 • n=4 Participants
|
|
Follow-up time from randomization/treatment
|
74 months
STANDARD_DEVIATION 7.5 • n=5 Participants
|
74 months
STANDARD_DEVIATION 7.1 • n=7 Participants
|
74 months
STANDARD_DEVIATION 7.1 • n=5 Participants
|
74 months
STANDARD_DEVIATION 7.2 • n=4 Participants
|
PRIMARY outcome
Timeframe: 5 to 7 yearsPopulation: Data from all trial participants were available with no withdrawals, drop-outs or missing data.
Number of patients who have had carpal tunnel release surgery on the study hand.
Outcome measures
| Measure |
Methylprednisolone 80 mg
n=37 Participants
Local injection of 80 mg Methylprednisolone into the carpal tunnel
Methylprednisolone 80 mg: 2 mL methylprednisolone (40 mg/mL) + 1 mL lidocaine
|
Methylprednisolone 40 mg
n=37 Participants
Local injection of 40 mg Methylprednisolone into the carpal tunnel
Methylprednisolone 40 mg: 1 mL methylprednisolone (40 mg/mL) + 1 mL saline + 1 mL lidocaine
|
Placebo
n=37 Participants
Local injection of saline into the carpal tunnel
Saline: 2 mL saline + 1 mL lidocaine
|
|---|---|---|---|
|
Number of Patients Who Have Had Carpal Tunnel Release Surgery on the Study Hand
|
31 Participants
|
34 Participants
|
36 Participants
|
PRIMARY outcome
Timeframe: 5-7 yearsChange in symptom severity score from baseline to 5 to 7 years. Score range 1 (no symptoms) to 5 (most severe symptoms).
Outcome measures
| Measure |
Methylprednisolone 80 mg
n=6 Participants
Local injection of 80 mg Methylprednisolone into the carpal tunnel
Methylprednisolone 80 mg: 2 mL methylprednisolone (40 mg/mL) + 1 mL lidocaine
|
Methylprednisolone 40 mg
n=101 Participants
Local injection of 40 mg Methylprednisolone into the carpal tunnel
Methylprednisolone 40 mg: 1 mL methylprednisolone (40 mg/mL) + 1 mL saline + 1 mL lidocaine
|
Placebo
Local injection of saline into the carpal tunnel
Saline: 2 mL saline + 1 mL lidocaine
|
|---|---|---|---|
|
Symptom Severity Score
|
1.34 score on a scale
Standard Deviation 0.9
|
1.53 score on a scale
Standard Deviation 0.9
|
—
|
SECONDARY outcome
Timeframe: 5-7 yearsScore for pain in the proximal palm and related activity limitations, range 0 (worst) to 100 (best).
Outcome measures
| Measure |
Methylprednisolone 80 mg
n=37 Participants
Local injection of 80 mg Methylprednisolone into the carpal tunnel
Methylprednisolone 80 mg: 2 mL methylprednisolone (40 mg/mL) + 1 mL lidocaine
|
Methylprednisolone 40 mg
n=37 Participants
Local injection of 40 mg Methylprednisolone into the carpal tunnel
Methylprednisolone 40 mg: 1 mL methylprednisolone (40 mg/mL) + 1 mL saline + 1 mL lidocaine
|
Placebo
n=37 Participants
Local injection of saline into the carpal tunnel
Saline: 2 mL saline + 1 mL lidocaine
|
|---|---|---|---|
|
Palmar Pain Score
|
86.4 score on a scale
Standard Deviation 18
|
84.6 score on a scale
Standard Deviation 22
|
83.0 score on a scale
Standard Deviation 25
|
SECONDARY outcome
Timeframe: 5-7 yearsScore for the 11-item DASH scale, a measure of activity limitations related to the upper extremity. Score range 0 (best) to 100 (worst)
Outcome measures
| Measure |
Methylprednisolone 80 mg
n=37 Participants
Local injection of 80 mg Methylprednisolone into the carpal tunnel
Methylprednisolone 80 mg: 2 mL methylprednisolone (40 mg/mL) + 1 mL lidocaine
|
Methylprednisolone 40 mg
n=37 Participants
Local injection of 40 mg Methylprednisolone into the carpal tunnel
Methylprednisolone 40 mg: 1 mL methylprednisolone (40 mg/mL) + 1 mL saline + 1 mL lidocaine
|
Placebo
n=37 Participants
Local injection of saline into the carpal tunnel
Saline: 2 mL saline + 1 mL lidocaine
|
|---|---|---|---|
|
11-item Disabilities of the Arm, Shoulder and Hand (DASH) Score
|
13.1 score on a scale
Standard Deviation 18
|
16.9 score on a scale
Standard Deviation 20
|
19.3 score on a scale
Standard Deviation 20
|
SECONDARY outcome
Timeframe: 5-7 yearsScore for the 2-item bodily pain scale, range 0 (worst) to 100 (best).
Outcome measures
| Measure |
Methylprednisolone 80 mg
n=37 Participants
Local injection of 80 mg Methylprednisolone into the carpal tunnel
Methylprednisolone 80 mg: 2 mL methylprednisolone (40 mg/mL) + 1 mL lidocaine
|
Methylprednisolone 40 mg
n=37 Participants
Local injection of 40 mg Methylprednisolone into the carpal tunnel
Methylprednisolone 40 mg: 1 mL methylprednisolone (40 mg/mL) + 1 mL saline + 1 mL lidocaine
|
Placebo
n=37 Participants
Local injection of saline into the carpal tunnel
Saline: 2 mL saline + 1 mL lidocaine
|
|---|---|---|---|
|
Bodily Pain Score
|
81.4 score on a scale
Standard Deviation 24
|
79.9 score on a scale
Standard Deviation 24
|
78.2 score on a scale
Standard Deviation 25
|
SECONDARY outcome
Timeframe: 5-7 yearsVisual analog scale about treatment satisfaction, score 0 (worst) to 100 (best).
Outcome measures
| Measure |
Methylprednisolone 80 mg
n=37 Participants
Local injection of 80 mg Methylprednisolone into the carpal tunnel
Methylprednisolone 80 mg: 2 mL methylprednisolone (40 mg/mL) + 1 mL lidocaine
|
Methylprednisolone 40 mg
n=37 Participants
Local injection of 40 mg Methylprednisolone into the carpal tunnel
Methylprednisolone 40 mg: 1 mL methylprednisolone (40 mg/mL) + 1 mL saline + 1 mL lidocaine
|
Placebo
n=37 Participants
Local injection of saline into the carpal tunnel
Saline: 2 mL saline + 1 mL lidocaine
|
|---|---|---|---|
|
Satisfaction Score
|
77.5 score on a scale
Standard Deviation 28
|
71.4 score on a scale
Standard Deviation 27
|
68.4 score on a scale
Standard Deviation 28
|
Adverse Events
Methylprednisolone 80 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Methylprednisolone 40 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Isam Atroshi
Hässleholm Hospital, Hässleholm, Sweden
Phone: +46443091260
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place