Trial Outcomes & Findings for Early Mobilization Following Arthroscopic Rotator Cuff Repair (NCT NCT01333527)
NCT ID: NCT01333527
Last Updated: 2021-10-15
Results Overview
a 5-part (physical symptoms, sports/recreation, work, lifestyle, emotions) 21-item disease specific questionnaire. Measured in percentage. 0% = worst, 100 % = best
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
211 participants
Primary outcome timeframe
Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Results posted on
2021-10-15
Participant Flow
Withdrew following randomization (n=5) Reasons: n=4 : Had Abduction pillow n=1: Excluded at surgery
Participant milestones
| Measure |
Group A (Early ROM)
Group A (early ROM) will use the sling for comfort only
No Sling: Early range of motion
|
Group B (Usual Care)
Group B (usual care) will be immobilized in a sling for 6 weeks.
Sling: Patients will use the sling for 6 weeks, as per usual care
|
|---|---|---|
|
Overall Study
STARTED
|
105
|
106
|
|
Overall Study
COMPLETED
|
87
|
89
|
|
Overall Study
NOT COMPLETED
|
18
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Early Mobilization Following Arthroscopic Rotator Cuff Repair
Baseline characteristics by cohort
| Measure |
Group A (Early ROM)
n=103 Participants
Group A (early ROM) used the sling for comfort only
|
Group B (Usual Care)
n=103 Participants
Group B (usual care) used the sling for 6 weeks
|
Total
n=206 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.5 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
56.2 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
55.85 years
STANDARD_DEVIATION 9.22 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
103 participants
n=5 Participants
|
103 participants
n=7 Participants
|
206 participants
n=5 Participants
|
|
Range of Motion
Flexion_Baseline
|
132.1 degrees
STANDARD_DEVIATION 30.7 • n=5 Participants
|
127.7 degrees
STANDARD_DEVIATION 35.6 • n=7 Participants
|
129.91 degrees
STANDARD_DEVIATION 33.21 • n=5 Participants
|
|
Range of Motion
Abduction_Baseline
|
122 degrees
STANDARD_DEVIATION 36.6 • n=5 Participants
|
118.9 degrees
STANDARD_DEVIATION 39.8 • n=7 Participants
|
120.44 degrees
STANDARD_DEVIATION 38.18 • n=5 Participants
|
|
Range of Motion
External rotation 90 degrees abduction
|
61.0 degrees
STANDARD_DEVIATION 34.8 • n=5 Participants
|
61.6 degrees
STANDARD_DEVIATION 31.8 • n=7 Participants
|
61.3 degrees
STANDARD_DEVIATION 33.23 • n=5 Participants
|
|
Range of Motion
Internal rotation with 90 degrees abduction
|
30.8 degrees
STANDARD_DEVIATION 19.1 • n=5 Participants
|
33.3 degrees
STANDARD_DEVIATION 17.8 • n=7 Participants
|
32.08 degrees
STANDARD_DEVIATION 18.43 • n=5 Participants
|
|
Western Ontario Rotator Cuff Index (WORC)
|
38.9 percentage
STANDARD_DEVIATION 18.5 • n=5 Participants
|
40.6 percentage
STANDARD_DEVIATION 17.2 • n=7 Participants
|
39.75 percentage
STANDARD_DEVIATION 17.88 • n=5 Participants
|
|
Pain scale (Visual Analogue)
pain at rest
|
3.1 units on a scale
STANDARD_DEVIATION 2.3 • n=5 Participants
|
2.9 units on a scale
STANDARD_DEVIATION 2.4 • n=7 Participants
|
3.0 units on a scale
STANDARD_DEVIATION 2.34 • n=5 Participants
|
|
Pain scale (Visual Analogue)
pain with activity
|
6.1 units on a scale
STANDARD_DEVIATION 2.4 • n=5 Participants
|
5.7 units on a scale
STANDARD_DEVIATION 2.4 • n=7 Participants
|
5.88 units on a scale
STANDARD_DEVIATION 2.39 • n=5 Participants
|
|
Pain scale (Visual Analogue)
pain at night
|
4.8 units on a scale
STANDARD_DEVIATION 2.6 • n=5 Participants
|
4.3 units on a scale
STANDARD_DEVIATION 2.7 • n=7 Participants
|
4.57 units on a scale
STANDARD_DEVIATION 2.68 • n=5 Participants
|
|
Strength (dynamometer microFIT3)
flexion
|
19.2 pounds
STANDARD_DEVIATION 10.9 • n=5 Participants
|
20.1 pounds
STANDARD_DEVIATION 12.3 • n=7 Participants
|
19.66 pounds
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Strength (dynamometer microFIT3)
abduction
|
18.0 pounds
STANDARD_DEVIATION 9.8 • n=5 Participants
|
18.0 pounds
STANDARD_DEVIATION 9.8 • n=7 Participants
|
18.0 pounds
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Strength (dynamometer microFIT3)
External rotation in abduction
|
11.2 pounds
STANDARD_DEVIATION 8.3 • n=5 Participants
|
11.9 pounds
STANDARD_DEVIATION 9.3 • n=7 Participants
|
11.54 pounds
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Strength (dynamometer microFIT3)
internal rotation in abduction
|
17.6 pounds
STANDARD_DEVIATION 12.3 • n=5 Participants
|
19.4 pounds
STANDARD_DEVIATION 14.0 • n=7 Participants
|
18.53 pounds
STANDARD_DEVIATION 13.21 • n=5 Participants
|
|
Strength (dynamometer microFIT3)
horizontal adduction
|
17.4 pounds
STANDARD_DEVIATION 11.8 • n=5 Participants
|
20.2 pounds
STANDARD_DEVIATION 13.3 • n=7 Participants
|
18.8 pounds
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Strength (dynamometer microFIT3)
scaption
|
13.99 pounds
STANDARD_DEVIATION 6.92 • n=5 Participants
|
14.14 pounds
STANDARD_DEVIATION 7.55 • n=7 Participants
|
14.07 pounds
STANDARD_DEVIATION 7.23 • n=5 Participants
|
|
Short-Form 36-Item Health Survey (SF-36)
physical functioning
|
72.1 units on a scale
STANDARD_DEVIATION 15.8 • n=5 Participants
|
71.7 units on a scale
STANDARD_DEVIATION 16.3 • n=7 Participants
|
71.87 units on a scale
STANDARD_DEVIATION 16.02 • n=5 Participants
|
|
Short-Form 36-Item Health Survey (SF-36)
role physical
|
33.5 units on a scale
STANDARD_DEVIATION 39.2 • n=5 Participants
|
35.7 units on a scale
STANDARD_DEVIATION 36.8 • n=7 Participants
|
34.59 units on a scale
STANDARD_DEVIATION 37.96 • n=5 Participants
|
|
Short-Form 36-Item Health Survey (SF-36)
Bodily pain
|
44.7 units on a scale
STANDARD_DEVIATION 17.2 • n=5 Participants
|
46.7 units on a scale
STANDARD_DEVIATION 18.9 • n=7 Participants
|
45.67 units on a scale
STANDARD_DEVIATION 18.03 • n=5 Participants
|
|
Short-Form 36-Item Health Survey (SF-36)
general health
|
78.8 units on a scale
STANDARD_DEVIATION 15.8 • n=5 Participants
|
76.0 units on a scale
STANDARD_DEVIATION 17.6 • n=7 Participants
|
77.39 units on a scale
STANDARD_DEVIATION 16.74 • n=5 Participants
|
|
Short-Form 36-Item Health Survey (SF-36)
vitality
|
61.0 units on a scale
STANDARD_DEVIATION 20.7 • n=5 Participants
|
62.2 units on a scale
STANDARD_DEVIATION 18.1 • n=7 Participants
|
61.62 units on a scale
STANDARD_DEVIATION 19.4 • n=5 Participants
|
|
Short-Form 36-Item Health Survey (SF-36)
social function
|
79.6 units on a scale
STANDARD_DEVIATION 21.9 • n=5 Participants
|
76.1 units on a scale
STANDARD_DEVIATION 22.1 • n=7 Participants
|
77.85 units on a scale
STANDARD_DEVIATION 22.02 • n=5 Participants
|
|
Short-Form 36-Item Health Survey (SF-36)
role emotional
|
78.6 units on a scale
STANDARD_DEVIATION 37.3 • n=5 Participants
|
80.3 units on a scale
STANDARD_DEVIATION 33.8 • n=7 Participants
|
79.45 units on a scale
STANDARD_DEVIATION 35.51 • n=5 Participants
|
|
Short-Form 36-Item Health Survey (SF-36)
mental health
|
78.4 units on a scale
STANDARD_DEVIATION 15.1 • n=5 Participants
|
77.7 units on a scale
STANDARD_DEVIATION 13.7 • n=7 Participants
|
78.08 units on a scale
STANDARD_DEVIATION 14.41 • n=5 Participants
|
|
Surgical Characteristics
Mean length of tear Anteroposterior
|
2.1 cm
STANDARD_DEVIATION 1.1 • n=5 Participants
|
2.1 cm
STANDARD_DEVIATION 1.0 • n=7 Participants
|
2.1 cm
STANDARD_DEVIATION 1.04 • n=5 Participants
|
|
Surgical Characteristics
Mean length of tear Mediolateral
|
1.9 cm
STANDARD_DEVIATION 1.1 • n=5 Participants
|
1.9 cm
STANDARD_DEVIATION 1.1 • n=7 Participants
|
1.9 cm
STANDARD_DEVIATION 1.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 monthsa 5-part (physical symptoms, sports/recreation, work, lifestyle, emotions) 21-item disease specific questionnaire. Measured in percentage. 0% = worst, 100 % = best
Outcome measures
| Measure |
Group A (Early ROM)
n=87 Participants
Group A (early ROM) will use the sling for comfort only
No Sling: Early range of motion
Overall number of Baseline participants: 103. \>18 years, continuous Sex: male and female Region of enrollment
|
Group B (Usual Care)
n=89 Participants
Group B (usual care) will be immobilized in a sling for 6 weeks.
Sling: Patients will use the sling for 6 weeks, as per usual care
Overall number of Baseline participants 103 \>18 years, continuous Sex: male and female Region of enrollment
|
|---|---|---|
|
Western Ontario Rotator Cuff Index (WORC)
Baseline
|
39.2 percentage
Standard Deviation 18.4
|
40.2 percentage
Standard Deviation 17.3
|
|
Western Ontario Rotator Cuff Index (WORC)
6 weeks
|
44.5 percentage
Standard Deviation 16.6
|
40.7 percentage
Standard Deviation 14.0
|
|
Western Ontario Rotator Cuff Index (WORC)
3 months
|
61.4 percentage
Standard Deviation 19.0
|
63.7 percentage
Standard Deviation 17.6
|
|
Western Ontario Rotator Cuff Index (WORC)
6 months
|
78.6 percentage
Standard Deviation 16.8
|
79.6 percentage
Standard Deviation 15.2
|
|
Western Ontario Rotator Cuff Index (WORC)
12 months
|
87.6 percentage
Standard Deviation 14.1
|
88.6 percentage
Standard Deviation 13.1
|
|
Western Ontario Rotator Cuff Index (WORC)
24 months
|
89.4 percentage
Standard Deviation 13.4
|
89.8 percentage
Standard Deviation 13.4
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 3 months, 6 months, 12 months and 24 monthsMeasured flexion, abduction, external rotation in 90 degrees abduction \[ER(90)\], internal rotation in 90 degrees abduction \[IR(90)\], horizontal adduction, scaption, degrees with a goniometer by the same tester throughout
Outcome measures
| Measure |
Group A (Early ROM)
n=87 Participants
Group A (early ROM) will use the sling for comfort only
No Sling: Early range of motion
Overall number of Baseline participants: 103. \>18 years, continuous Sex: male and female Region of enrollment
|
Group B (Usual Care)
n=89 Participants
Group B (usual care) will be immobilized in a sling for 6 weeks.
Sling: Patients will use the sling for 6 weeks, as per usual care
Overall number of Baseline participants 103 \>18 years, continuous Sex: male and female Region of enrollment
|
|---|---|---|
|
Range of Motion (ROM)
Forward Flexion baseline
|
131.5 degrees
Standard Deviation 30.0
|
127.4 degrees
Standard Deviation 34.9
|
|
Range of Motion (ROM)
Forward Flexion 6 weeks
|
90.0 degrees
Standard Deviation 33.4
|
78.9 degrees
Standard Deviation 34.5
|
|
Range of Motion (ROM)
Forward Flexion 3 months
|
125.5 degrees
Standard Deviation 28.5
|
121.0 degrees
Standard Deviation 30.1
|
|
Range of Motion (ROM)
Forward Flexion 6 months
|
142.3 degrees
Standard Deviation 22.6
|
141.3 degrees
Standard Deviation 22.6
|
|
Range of Motion (ROM)
Forward Flexion12 months
|
150.9 degrees
Standard Deviation 12.6
|
149.0 degrees
Standard Deviation 19.9
|
|
Range of Motion (ROM)
Forward Flexion 24 months
|
155.5 degrees
Standard Deviation 12.7
|
152.2 degrees
Standard Deviation 18.5
|
|
Range of Motion (ROM)
Abduction baseline
|
121.1 degrees
Standard Deviation 36.0
|
118.6 degrees
Standard Deviation 39.4
|
|
Range of Motion (ROM)
Abduction 6 weeks
|
75.4 degrees
Standard Deviation 36.8
|
67.1 degrees
Standard Deviation 32.9
|
|
Range of Motion (ROM)
Abduction 3 months
|
119.1 degrees
Standard Deviation 31.3
|
116.0 degrees
Standard Deviation 37.6
|
|
Range of Motion (ROM)
Abduction 6 months
|
139.4 degrees
Standard Deviation 23.5
|
139.5 degrees
Standard Deviation 27.6
|
|
Range of Motion (ROM)
Abduction 12 months
|
150.0 degrees
Standard Deviation 15.3
|
148.4 degrees
Standard Deviation 22.4
|
|
Range of Motion (ROM)
Abduction 24 months
|
153.5 degrees
Standard Deviation 14.6
|
152.2 degrees
Standard Deviation 21.9
|
|
Range of Motion (ROM)
External Rotation in Abduction Baseline
|
62.2 degrees
Standard Deviation 34.1
|
61.6 degrees
Standard Deviation 31.6
|
|
Range of Motion (ROM)
External Rotation in Abduction 6 weeks
|
22.0 degrees
Standard Deviation 29.2
|
19.5 degrees
Standard Deviation 28.8
|
|
Range of Motion (ROM)
External Rotation in Abduction 3 months
|
53.0 degrees
Standard Deviation 27.6
|
44.2 degrees
Standard Deviation 28.8
|
|
Range of Motion (ROM)
External Rotation in Abduction 6 months
|
67.6 degrees
Standard Deviation 21.0
|
62.9 degrees
Standard Deviation 21.6
|
|
Range of Motion (ROM)
External Rotation in Abduction 12 months
|
75.3 degrees
Standard Deviation 16.2
|
70.6 degrees
Standard Deviation 18.8
|
|
Range of Motion (ROM)
External Rotation in Abduction 24 months
|
76.0 degrees
Standard Deviation 14.8
|
71.5 degrees
Standard Deviation 17.8
|
|
Range of Motion (ROM)
Internal rotation in abduction baseline
|
30.6 degrees
Standard Deviation 18.6
|
33.2 degrees
Standard Deviation 17.6
|
|
Range of Motion (ROM)
Internal rotation in abduction 6 weeks
|
14.1 degrees
Standard Deviation 18.6
|
11.8 degrees
Standard Deviation 16.6
|
|
Range of Motion (ROM)
Internal rotation in abduction 3 months
|
30.2 degrees
Standard Deviation 15.2
|
25.9 degrees
Standard Deviation 16.3
|
|
Range of Motion (ROM)
Internal rotation in abduction 6 months
|
35.9 degrees
Standard Deviation 12.1
|
35.5 degrees
Standard Deviation 12.2
|
|
Range of Motion (ROM)
Internal rotation in abduction 12 months
|
39.0 degrees
Standard Deviation 12.4
|
40.1 degrees
Standard Deviation 14.4
|
|
Range of Motion (ROM)
Internal rotation in abduction 24 months
|
40.9 degrees
Standard Deviation 12.0
|
38.7 degrees
Standard Deviation 12.4
|
|
Range of Motion (ROM)
Horizontal adduction baseline
|
13.2 degrees
Standard Deviation 9.2
|
14.4 degrees
Standard Deviation 10.3
|
|
Range of Motion (ROM)
Horizontal adduction 6 weeks
|
8.2 degrees
Standard Deviation 10.0
|
6.4 degrees
Standard Deviation 9.3
|
|
Range of Motion (ROM)
Horizontal adduction 3 months
|
14.9 degrees
Standard Deviation 9.7
|
13.0 degrees
Standard Deviation 9.7
|
|
Range of Motion (ROM)
Horizontal adduction 6 months
|
19.4 degrees
Standard Deviation 13.5
|
18.1 degrees
Standard Deviation 9.9
|
|
Range of Motion (ROM)
Horizontal adduction 12 months
|
19.1 degrees
Standard Deviation 10.4
|
18.9 degrees
Standard Deviation 10.4
|
|
Range of Motion (ROM)
Horizontal adduction 24 months
|
20.4 degrees
Standard Deviation 10.5
|
19.5 degrees
Standard Deviation 11.5
|
|
Range of Motion (ROM)
Scaption baseline
|
124.6 degrees
Standard Deviation 31.3
|
123.6 degrees
Standard Deviation 34.8
|
|
Range of Motion (ROM)
Scaption 6 weeks
|
80.4 degrees
Standard Deviation 33.1
|
75.8 degrees
Standard Deviation 36.3
|
|
Range of Motion (ROM)
Scaption 3 months
|
120.7 degrees
Standard Deviation 28.0
|
118.5 degrees
Standard Deviation 31.0
|
|
Range of Motion (ROM)
Scaption 6 months
|
138.0 degrees
Standard Deviation 21.4
|
137.9 degrees
Standard Deviation 23.6
|
|
Range of Motion (ROM)
Scaption 12 months
|
148.7 degrees
Standard Deviation 11.7
|
146.7 degrees
Standard Deviation 20.2
|
|
Range of Motion (ROM)
Scaption 24 months
|
151.7 degrees
Standard Deviation 12.8
|
149.7 degrees
Standard Deviation 18.8
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 months, 24 monthsstrength was measured in pounds of force using a dynamometer (microFET3, Hoggan Health Industries, West Jordan, UT). Isometric shoulder flexion, abduction, were measured with the arm in neutral abduction and elbow at 90 degrees flexion. External and internal rotation were measured in 90 degrees of abduction. Peak values were recorded during each contraction which was held for 3 seconds. Values were expressed as raw values.
Outcome measures
| Measure |
Group A (Early ROM)
n=87 Participants
Group A (early ROM) will use the sling for comfort only
No Sling: Early range of motion
Overall number of Baseline participants: 103. \>18 years, continuous Sex: male and female Region of enrollment
|
Group B (Usual Care)
n=89 Participants
Group B (usual care) will be immobilized in a sling for 6 weeks.
Sling: Patients will use the sling for 6 weeks, as per usual care
Overall number of Baseline participants 103 \>18 years, continuous Sex: male and female Region of enrollment
|
|---|---|---|
|
Strength
Flexion baseline
|
19.6 pounds
Standard Deviation 10.9
|
19.8 pounds
Standard Deviation 12.3
|
|
Strength
Flexion 6 months
|
26.3 pounds
Standard Deviation 12.6
|
27.1 pounds
Standard Deviation 10.8
|
|
Strength
Flexion 12 months
|
29.7 pounds
Standard Deviation 13.7
|
31.0 pounds
Standard Deviation 12.7
|
|
Strength
Flexion 24 months
|
28.3 pounds
Standard Deviation 11.5
|
29.1 pounds
Standard Deviation 11.7
|
|
Strength
Abduction baseline
|
18.6 pounds
Standard Deviation 10.0
|
17.8 pounds
Standard Deviation 10.1
|
|
Strength
Abduction 6 months
|
23.2 pounds
Standard Deviation 10.1
|
23.2 pounds
Standard Deviation 9.3
|
|
Strength
Abduction 12 months
|
26.8 pounds
Standard Deviation 10.7
|
26.9 pounds
Standard Deviation 10.5
|
|
Strength
Abduction 24 months
|
26.9 pounds
Standard Deviation 9.6
|
28.2 pounds
Standard Deviation 10.6
|
|
Strength
External rotation in abduction baseline
|
11.5 pounds
Standard Deviation 8.4
|
11.9 pounds
Standard Deviation 9.6
|
|
Strength
External rotation in abduction 6 months
|
18.2 pounds
Standard Deviation 9.4
|
18.7 pounds
Standard Deviation 10.1
|
|
Strength
External rotation in abduction 12 months
|
23.3 pounds
Standard Deviation 12.5
|
24.0 pounds
Standard Deviation 12.3
|
|
Strength
External rotation in abduction 24 months
|
25.1 pounds
Standard Deviation 12.5
|
24.8 pounds
Standard Deviation 11.8
|
|
Strength
Internal rotation in abduction baseline
|
18.1 pounds
Standard Deviation 12.7
|
19.5 pounds
Standard Deviation 14.1
|
|
Strength
Internal rotation in abduction 6 months
|
27.1 pounds
Standard Deviation 14.5
|
26.7 pounds
Standard Deviation 12.5
|
|
Strength
Internal rotation in abduction 12 months
|
30.9 pounds
Standard Deviation 15.2
|
32.3 pounds
Standard Deviation 14.4
|
|
Strength
Internal rotation in abduction 24 months
|
30.6 pounds
Standard Deviation 13.1
|
31.3 pounds
Standard Deviation 13.4
|
|
Strength
Horizontal Adduction baseline
|
17.7 pounds
Standard Deviation 12.2
|
20.0 pounds
Standard Deviation 13.4
|
|
Strength
Horizontal Adduction 6 months
|
25.7 pounds
Standard Deviation 12.1
|
25.4 pounds
Standard Deviation 10.7
|
|
Strength
Horizontal Adduction 12 months
|
28.1 pounds
Standard Deviation 11.3
|
28.4 pounds
Standard Deviation 11.6
|
|
Strength
Horizontal Adduction 24 months
|
27.9 pounds
Standard Deviation 9.8
|
28.2 pounds
Standard Deviation 11.1
|
|
Strength
Scaption baseline
|
14.2 pounds
Standard Deviation 7.1
|
13.9 pounds
Standard Deviation 7.2
|
|
Strength
Scaption 6 months
|
16.4 pounds
Standard Deviation 6.9
|
16.3 pounds
Standard Deviation 6.5
|
|
Strength
Scaption 12 months
|
19.8 pounds
Standard Deviation 7.3
|
19.1 pounds
Standard Deviation 7.0
|
|
Strength
Scaption 24 months
|
20.6 pounds
Standard Deviation 7.0
|
19.7 pounds
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: baseline, 6 weeks, 3 months, 6 months, 12 months and 24 monthsThe Short Form (36) Health Survey is a quality of life questionnaire that looks at eight scales: physical functioning, Role-physical, bodily pain, general health, vitality, social function, role-emotional, mental health. Each scale ranges between 0 (completely disable) to 100 (completely able).
Outcome measures
| Measure |
Group A (Early ROM)
n=87 Participants
Group A (early ROM) will use the sling for comfort only
No Sling: Early range of motion
Overall number of Baseline participants: 103. \>18 years, continuous Sex: male and female Region of enrollment
|
Group B (Usual Care)
n=89 Participants
Group B (usual care) will be immobilized in a sling for 6 weeks.
Sling: Patients will use the sling for 6 weeks, as per usual care
Overall number of Baseline participants 103 \>18 years, continuous Sex: male and female Region of enrollment
|
|---|---|---|
|
The Short Form (36) Health Survey
Mental health 6 weeks
|
79.5 units on a scale
Standard Deviation 15.6
|
76.3 units on a scale
Standard Deviation 15.4
|
|
The Short Form (36) Health Survey
physical functioning baseline
|
72.8 units on a scale
Standard Deviation 15.2
|
71.3 units on a scale
Standard Deviation 16.7
|
|
The Short Form (36) Health Survey
physical functioning 6 weeks
|
68.2 units on a scale
Standard Deviation 14.2
|
64.7 units on a scale
Standard Deviation 15.2
|
|
The Short Form (36) Health Survey
physical functioning 3 months
|
75.0 units on a scale
Standard Deviation 15.9
|
73.7 units on a scale
Standard Deviation 16.3
|
|
The Short Form (36) Health Survey
physical functioning 6 months
|
84.4 units on a scale
Standard Deviation 14.1
|
82.7 units on a scale
Standard Deviation 18.1
|
|
The Short Form (36) Health Survey
physical functioning 12 months
|
89.3 units on a scale
Standard Deviation 13.2
|
86.3 units on a scale
Standard Deviation 18.2
|
|
The Short Form (36) Health Survey
physical functioning 24 months
|
86.8 units on a scale
Standard Deviation 15.4
|
85.7 units on a scale
Standard Deviation 16.9
|
|
The Short Form (36) Health Survey
role physical baseline
|
33.2 units on a scale
Standard Deviation 39.1
|
36.6 units on a scale
Standard Deviation 37.7
|
|
The Short Form (36) Health Survey
role physical 6 weeks
|
14.7 units on a scale
Standard Deviation 28.8
|
10.6 units on a scale
Standard Deviation 25.4
|
|
The Short Form (36) Health Survey
role physical 3 months
|
40.9 units on a scale
Standard Deviation 42.7
|
37.5 units on a scale
Standard Deviation 41.2
|
|
The Short Form (36) Health Survey
role physical 6 months
|
71.1 units on a scale
Standard Deviation 37.6
|
65.6 units on a scale
Standard Deviation 40.2
|
|
The Short Form (36) Health Survey
role physical 12 months
|
86.1 units on a scale
Standard Deviation 29.6
|
79.8 units on a scale
Standard Deviation 35.8
|
|
The Short Form (36) Health Survey
role physical 24 months
|
81.8 units on a scale
Standard Deviation 33.6
|
74.4 units on a scale
Standard Deviation 38.8
|
|
The Short Form (36) Health Survey
bodily pain baseline
|
43.5 units on a scale
Standard Deviation 16.4
|
46.3 units on a scale
Standard Deviation 18.6
|
|
The Short Form (36) Health Survey
bodily pain 6 weeks
|
50.2 units on a scale
Standard Deviation 22.8
|
45.5 units on a scale
Standard Deviation 24.0
|
|
The Short Form (36) Health Survey
bodily pain 3 months
|
62.5 units on a scale
Standard Deviation 22.5
|
66.5 units on a scale
Standard Deviation 20.5
|
|
The Short Form (36) Health Survey
bodily pain 6 months
|
69.5 units on a scale
Standard Deviation 17.8
|
71.7 units on a scale
Standard Deviation 19.2
|
|
The Short Form (36) Health Survey
bodily pain 12 months
|
74.6 units on a scale
Standard Deviation 20.0
|
75.5 units on a scale
Standard Deviation 20.8
|
|
The Short Form (36) Health Survey
bodily pain 24 months
|
73.2 units on a scale
Standard Deviation 22.2
|
76.7 units on a scale
Standard Deviation 22.7
|
|
The Short Form (36) Health Survey
General Health baseline
|
79.0 units on a scale
Standard Deviation 15.4
|
76.0 units on a scale
Standard Deviation 17.9
|
|
The Short Form (36) Health Survey
General Health 6 weeks
|
78.0 units on a scale
Standard Deviation 17.1
|
77.7 units on a scale
Standard Deviation 17.0
|
|
The Short Form (36) Health Survey
General Health 3 months
|
77.6 units on a scale
Standard Deviation 14.7
|
79.3 units on a scale
Standard Deviation 17.0
|
|
The Short Form (36) Health Survey
General Health 6 months
|
81.1 units on a scale
Standard Deviation 13.5
|
79.7 units on a scale
Standard Deviation 15.4
|
|
The Short Form (36) Health Survey
General Health 12 months
|
80.3 units on a scale
Standard Deviation 14.6
|
80.1 units on a scale
Standard Deviation 15.7
|
|
The Short Form (36) Health Survey
General Health 24 months
|
78.8 units on a scale
Standard Deviation 17.3
|
77.2 units on a scale
Standard Deviation 20.0
|
|
The Short Form (36) Health Survey
Vitality baseline
|
61.0 units on a scale
Standard Deviation 20.3
|
63.2 units on a scale
Standard Deviation 18.2
|
|
The Short Form (36) Health Survey
Vitality 6 weeks
|
58.9 units on a scale
Standard Deviation 18.8
|
57.3 units on a scale
Standard Deviation 19.2
|
|
The Short Form (36) Health Survey
Vitality 3 months
|
65.9 units on a scale
Standard Deviation 18.1
|
68.0 units on a scale
Standard Deviation 16.7
|
|
The Short Form (36) Health Survey
Vitality 6 months
|
70.4 units on a scale
Standard Deviation 15.4
|
72.9 units on a scale
Standard Deviation 14.0
|
|
The Short Form (36) Health Survey
Vitality 12 months
|
73.2 units on a scale
Standard Deviation 15.4
|
73.9 units on a scale
Standard Deviation 14.0
|
|
The Short Form (36) Health Survey
Vitality 24 months
|
70.7 units on a scale
Standard Deviation 19.9
|
73.9 units on a scale
Standard Deviation 16.3
|
|
The Short Form (36) Health Survey
Social function baseline
|
79.0 units on a scale
Standard Deviation 22.2
|
76.5 units on a scale
Standard Deviation 22.1
|
|
The Short Form (36) Health Survey
Social function 6 weeks
|
70.0 units on a scale
Standard Deviation 26.3
|
61.7 units on a scale
Standard Deviation 26.1
|
|
The Short Form (36) Health Survey
Social function 3 months
|
82.4 units on a scale
Standard Deviation 20.0
|
81.1 units on a scale
Standard Deviation 20.6
|
|
The Short Form (36) Health Survey
Social function 6 months
|
90.5 units on a scale
Standard Deviation 16.5
|
90.4 units on a scale
Standard Deviation 15.4
|
|
The Short Form (36) Health Survey
Social function 12 months
|
90.4 units on a scale
Standard Deviation 17.1
|
91.1 units on a scale
Standard Deviation 17.2
|
|
The Short Form (36) Health Survey
Social function 24 months
|
86.4 units on a scale
Standard Deviation 21.3
|
88.7 units on a scale
Standard Deviation 18.8
|
|
The Short Form (36) Health Survey
role emotional baseline
|
80.2 units on a scale
Standard Deviation 36.2
|
81.4 units on a scale
Standard Deviation 33.9
|
|
The Short Form (36) Health Survey
role emotional 6 weeks
|
65.9 units on a scale
Standard Deviation 42.7
|
64.2 units on a scale
Standard Deviation 43.0
|
|
The Short Form (36) Health Survey
role emotional 3 months
|
78.0 units on a scale
Standard Deviation 37.6
|
74.5 units on a scale
Standard Deviation 38.4
|
|
The Short Form (36) Health Survey
role emotional 6 months
|
89.4 units on a scale
Standard Deviation 26.7
|
82.8 units on a scale
Standard Deviation 34.5
|
|
The Short Form (36) Health Survey
role emotional 12 months
|
90.7 units on a scale
Standard Deviation 25.8
|
89.3 units on a scale
Standard Deviation 25.3
|
|
The Short Form (36) Health Survey
role emotional 24 months
|
92.2 units on a scale
Standard Deviation 20.9
|
88.2 units on a scale
Standard Deviation 27.5
|
|
The Short Form (36) Health Survey
Mental health baseline
|
79.0 units on a scale
Standard Deviation 13.9
|
78.5 units on a scale
Standard Deviation 13.4
|
|
The Short Form (36) Health Survey
Mental health 3 months
|
79.8 units on a scale
Standard Deviation 15.8
|
82.4 units on a scale
Standard Deviation 12.8
|
|
The Short Form (36) Health Survey
Mental health 6 months
|
81.9 units on a scale
Standard Deviation 13.8
|
83.9 units on a scale
Standard Deviation 12.4
|
|
The Short Form (36) Health Survey
Mental health 12 months
|
82.8 units on a scale
Standard Deviation 15.0
|
83.1 units on a scale
Standard Deviation 12.2
|
|
The Short Form (36) Health Survey
Mental health 24 months
|
81.4 units on a scale
Standard Deviation 14.8
|
84.1 units on a scale
Standard Deviation 12.0
|
SECONDARY outcome
Timeframe: 2 weeks, 6 weeks, 3 months, 6monthsPopulation: Expected, surgical procedure related: superficial infection, frozen shoulder, biceps rupture, persistent pain, reinjury Unexpected, not treatment related: Traumatic reinjury
The following complications were monitored throughout study: * Medical related: urinary, gastrointestinal, cardiac, pulmonary, metabolic * Surgical related: nerve injury, superficial or deep infection, dislocation, frozen shoulder, hematoma, biceps rupture, failure of tendon healing, dermatitis, reflex sympathetic dystrophy (RSD), persistent pain, re-injury. * Other The surgeon responsible for the patient used clinical judgment to make a decision regarding if the complication was related or not to the treatment being tested (use or not of sling).
Outcome measures
| Measure |
Group A (Early ROM)
n=87 Participants
Group A (early ROM) will use the sling for comfort only
No Sling: Early range of motion
Overall number of Baseline participants: 103. \>18 years, continuous Sex: male and female Region of enrollment
|
Group B (Usual Care)
n=89 Participants
Group B (usual care) will be immobilized in a sling for 6 weeks.
Sling: Patients will use the sling for 6 weeks, as per usual care
Overall number of Baseline participants 103 \>18 years, continuous Sex: male and female Region of enrollment
|
|---|---|---|
|
Adverse Events
Superficial Infection
|
0 Participants
|
1 Participants
|
|
Adverse Events
Frozen Shoulder
|
1 Participants
|
2 Participants
|
|
Adverse Events
Biceps Rupture
|
1 Participants
|
1 Participants
|
|
Adverse Events
Persistent Pain
|
10 Participants
|
6 Participants
|
|
Adverse Events
Re-injury not requiring surgery
|
5 Participants
|
4 Participants
|
|
Adverse Events
Urinary
|
0 Participants
|
0 Participants
|
|
Adverse Events
Gastrointestinal
|
0 Participants
|
0 Participants
|
|
Adverse Events
Cardiac
|
0 Participants
|
0 Participants
|
|
Adverse Events
Pulmonary
|
0 Participants
|
0 Participants
|
|
Adverse Events
Metabolic
|
0 Participants
|
0 Participants
|
|
Adverse Events
Nerve Injury
|
0 Participants
|
0 Participants
|
|
Adverse Events
Deep infection
|
0 Participants
|
0 Participants
|
|
Adverse Events
Dislocation
|
0 Participants
|
0 Participants
|
|
Adverse Events
Hematoma
|
0 Participants
|
0 Participants
|
|
Adverse Events
Dermatitis
|
0 Participants
|
0 Participants
|
|
Adverse Events
Reflex Sympathetic Dystrophy (RSD)
|
0 Participants
|
0 Participants
|
|
Adverse Events
Traumatic Re-injury
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: baseline, 6 weeks, 3, 6, 12, 24 monthsShoulder pain at rest, with activity and at night were measured using a visual analogue scale of 0-10 (no pain to severe pain)
Outcome measures
| Measure |
Group A (Early ROM)
n=87 Participants
Group A (early ROM) will use the sling for comfort only
No Sling: Early range of motion
Overall number of Baseline participants: 103. \>18 years, continuous Sex: male and female Region of enrollment
|
Group B (Usual Care)
n=89 Participants
Group B (usual care) will be immobilized in a sling for 6 weeks.
Sling: Patients will use the sling for 6 weeks, as per usual care
Overall number of Baseline participants 103 \>18 years, continuous Sex: male and female Region of enrollment
|
|---|---|---|
|
Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months
Pain at rest - baseline
|
3.1 centimeters
Standard Deviation 2.3
|
2.9 centimeters
Standard Deviation 2.4
|
|
Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months
Pain at rest 6 weeks
|
2.2 centimeters
Standard Deviation 2.0
|
2.0 centimeters
Standard Deviation 1.9
|
|
Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months
Pain at rest 3 months
|
1.8 centimeters
Standard Deviation 2.1
|
1.4 centimeters
Standard Deviation 1.6
|
|
Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months
Pain at rest 6 months
|
0.9 centimeters
Standard Deviation 1.3
|
0.8 centimeters
Standard Deviation 1.0
|
|
Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months
Pain at rest 12 months
|
0.6 centimeters
Standard Deviation 1.0
|
0.6 centimeters
Standard Deviation 1.0
|
|
Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months
Pain at rest 24 months
|
0.7 centimeters
Standard Deviation 1.3
|
0.6 centimeters
Standard Deviation 1.3
|
|
Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months
Pain with activity - baseline
|
6.1 centimeters
Standard Deviation 2.4
|
5.8 centimeters
Standard Deviation 2.3
|
|
Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months
Pain with activity 6 weeks
|
4.4 centimeters
Standard Deviation 2.5
|
3.9 centimeters
Standard Deviation 2.1
|
|
Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months
Pain with activity 3 months
|
3.4 centimeters
Standard Deviation 2.4
|
2.8 centimeters
Standard Deviation 1.9
|
|
Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months
Pain with activity 6 months
|
2.2 centimeters
Standard Deviation 1.9
|
1.8 centimeters
Standard Deviation 1.5
|
|
Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months
Pain with activity 12 months
|
1.2 centimeters
Standard Deviation 1.4
|
1.2 centimeters
Standard Deviation 1.4
|
|
Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months
Pain with activity 24 months
|
1.2 centimeters
Standard Deviation 1.6
|
1.0 centimeters
Standard Deviation 1.6
|
|
Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months
Pain at night - baseline
|
4.8 centimeters
Standard Deviation 2.6
|
4.4 centimeters
Standard Deviation 2.7
|
|
Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months
Pain at night 6 weeks
|
3.3 centimeters
Standard Deviation 2.5
|
2.8 centimeters
Standard Deviation 2.1
|
|
Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months
Pain at night 3 months
|
2.3 centimeters
Standard Deviation 2.4
|
2.1 centimeters
Standard Deviation 2.0
|
|
Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months
Pain at night 6 months
|
1.1 centimeters
Standard Deviation 1.6
|
1.0 centimeters
Standard Deviation 1.2
|
|
Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months
Pain at night 12 months
|
0.6 centimeters
Standard Deviation 0.8
|
0.8 centimeters
Standard Deviation 1.4
|
|
Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months
Pain at night 24 months
|
0.9 centimeters
Standard Deviation 1.6
|
0.7 centimeters
Standard Deviation 1.4
|
Adverse Events
Group A (Early ROM)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Group B (Usual Care)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A (Early ROM)
n=103 participants at risk
Group A (early ROM) will use the sling for comfort only
No Sling: Early range of motion
Overall number of Baseline participants: 103. \>18 years, continuous Sex: male and female Region of enrollment
|
Group B (Usual Care)
n=103 participants at risk
Group B (usual care) will be immobilized in a sling for 6 weeks.
Sling: Patients will use the sling for 6 weeks, as per usual care
Overall number of Baseline participants 103 \>18 years, continuous Sex: male and female Region of enrollment
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Persistent Pain
|
9.7%
10/103 • Number of events 10 • Over 24 months
|
5.8%
6/103 • Number of events 6 • Over 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place