Rotator Cuff Tear
Conditions
Brief summary
Shoulder rotator cuff (RC) tears are a significant cause of pain and disability. Surgery is done to reconnect the torn RC tendon(s) to the bone. The goals of RC surgery are to decrease pain, and to increase range of motion (ROM) and strength. This is done arthroscopically; through a small incision in the patient's shoulder. After surgery, patients are usually placed in a sling for up to 6 weeks to protect the repaired shoulder tendons. During this time, ROM exercises are only done by using the un-operated arm for assistance. Voluntary or active shoulder movement is usually not permitted to allow the repaired tendons to heal. Unfortunately, some patients develop shoulder stiffness while wearing the sling, which can delay rehabilitation. Any delays in rehabilitation may result in reduced shoulder function, a slower return-to-work or daily activities, and may also impact the health care system, through increased use and cost of rehabilitation. This study's purpose is to determine if patients can safely stop wearing their sling as early as pain and comfort allow following RC surgery. A total of 200 patients (100 per group) will be randomly assigned to one of two study groups: Patients in Group A (accelerated rehab) will wear their sling for comfort only following surgery. Self-assisted ROM exercises are allowed at any time. This means that patients may stop wearing their sling if pain and comfort allow, and start active movement for activities of daily living only. Patients in Group B (standard rehab) will wear their sling for 6 weeks. Like in group A, self-assisted ROM exercises are allowed at any time, but active movement will not be allowed until 6 weeks after surgery. Patients in both groups will be given the same self-assisted ROM exercises after surgery. Patients who agree to participate in the study will see their surgeon and the study physical therapist/research coordinator on 6 occasions (pre-surgery, 2 weeks, 6 weeks, 3, 6, 12 months post-surgery). Each visit will take about 30 minutes and will include a ROM assessment, strength assessment (as appropriate) and disease-specific quality of life questionnaires. Patients will also undergo an Ultrasound exam to verify that their RC repair is intact at 12-months. Differences in ROM, strength, questionnaire scores, RC integrity, and adverse events will be examined between the two groups. Differences will also be examined according to RC tear size and patient characteristics.
Interventions
Sponsors
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Patient is over 18 years of age 2. Patient has attempted non-operative treatment (i.e. physical therapy consisting of progressive ROM, strengthening, and postural exercises) 3. Patient has a full-thickness tear of the supraspinatus and/or infraspinatus, as confirmed by appropriate diagnostic imaging (MRI, Arthrogram, Ultrasound)
Exclusion criteria
1. Patient has a full-thickness tear of the subscapularis and/or teres minor 2. Patient has undergone previous RC surgery to the affected shoulder 3. Patient has major joint trauma, infection, or avascular necrosis 4. Patient has chronic dislocation, inflammation, or degenerative glenohumeral arthropathy 5. Patient has evidence of significant cuff arthropathy (superior glenohumeral translation and/or acromial erosion, as diagnosed by diagnostic imaging) 6. Patient has a psychiatric illness, cognitive impairment, or other health condition (i.e. visual impairment) which precludes informed consent or renders the patient unable to complete study questionnaires 7. Patient has a major medical illness where life expectancy is less than 2 years 8. Patient does not speak/read/understand English 9. Patient has no fixed address or means of contact 10. Surgeon or patient has decided to cancel surgery 11. Surgeon concludes that an arthroscopic repair is not appropriate at time of surgery (based on RC tear characteristics or concomitant shoulder pathology) 12. Patient unwilling to complete necessary follow-ups
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario Rotator Cuff Index (WORC) | Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months | a 5-part (physical symptoms, sports/recreation, work, lifestyle, emotions) 21-item disease specific questionnaire. Measured in percentage. 0% = worst, 100 % = best |
| Range of Motion (ROM) | baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months | Measured 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Strength | Baseline, 6 months, 12 months, 24 months | strength 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. |
| The Short Form (36) Health Survey | baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months | The 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). |
| Adverse Events | 2 weeks, 6 weeks, 3 months, 6months | 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). |
| Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months | baseline, 6 weeks, 3, 6, 12, 24 months | Shoulder pain at rest, with activity and at night were measured using a visual analogue scale of 0-10 (no pain to severe pain) |
Countries
Canada
Participant flow
Pre-assignment details
Withdrew following randomization (n=5) Reasons: n=4 : Had Abduction pillow n=1: Excluded at surgery
Participants by arm
| Arm | Count |
|---|---|
| Group A (Early ROM) Group A (early ROM) used the sling for comfort only | 103 |
| Group B (Usual Care) Group B (usual care) used the sling for 6 weeks | 103 |
| Total | 206 |
Baseline characteristics
| Characteristic | Group B (Usual Care) | Group A (Early ROM) | Total |
|---|---|---|---|
| Age, Continuous | 56.2 years STANDARD_DEVIATION 10.1 | 55.5 years STANDARD_DEVIATION 8.3 | 55.85 years STANDARD_DEVIATION 9.22 |
| Pain scale (Visual Analogue) pain at night | 4.3 units on a scale STANDARD_DEVIATION 2.7 | 4.8 units on a scale STANDARD_DEVIATION 2.6 | 4.57 units on a scale STANDARD_DEVIATION 2.68 |
| Pain scale (Visual Analogue) pain at rest | 2.9 units on a scale STANDARD_DEVIATION 2.4 | 3.1 units on a scale STANDARD_DEVIATION 2.3 | 3.0 units on a scale STANDARD_DEVIATION 2.34 |
| Pain scale (Visual Analogue) pain with activity | 5.7 units on a scale STANDARD_DEVIATION 2.4 | 6.1 units on a scale STANDARD_DEVIATION 2.4 | 5.88 units on a scale STANDARD_DEVIATION 2.39 |
| Range of Motion Abduction_Baseline | 118.9 degrees STANDARD_DEVIATION 39.8 | 122 degrees STANDARD_DEVIATION 36.6 | 120.44 degrees STANDARD_DEVIATION 38.18 |
| Range of Motion External rotation 90 degrees abduction | 61.6 degrees STANDARD_DEVIATION 31.8 | 61.0 degrees STANDARD_DEVIATION 34.8 | 61.3 degrees STANDARD_DEVIATION 33.23 |
| Range of Motion Flexion_Baseline | 127.7 degrees STANDARD_DEVIATION 35.6 | 132.1 degrees STANDARD_DEVIATION 30.7 | 129.91 degrees STANDARD_DEVIATION 33.21 |
| Range of Motion Internal rotation with 90 degrees abduction | 33.3 degrees STANDARD_DEVIATION 17.8 | 30.8 degrees STANDARD_DEVIATION 19.1 | 32.08 degrees STANDARD_DEVIATION 18.43 |
| Region of Enrollment Canada | 103 participants | 103 participants | 206 participants |
| Sex: Female, Male Female | 37 Participants | 38 Participants | 75 Participants |
| Sex: Female, Male Male | 66 Participants | 65 Participants | 131 Participants |
| Short-Form 36-Item Health Survey (SF-36) Bodily pain | 46.7 units on a scale STANDARD_DEVIATION 18.9 | 44.7 units on a scale STANDARD_DEVIATION 17.2 | 45.67 units on a scale STANDARD_DEVIATION 18.03 |
| Short-Form 36-Item Health Survey (SF-36) general health | 76.0 units on a scale STANDARD_DEVIATION 17.6 | 78.8 units on a scale STANDARD_DEVIATION 15.8 | 77.39 units on a scale STANDARD_DEVIATION 16.74 |
| Short-Form 36-Item Health Survey (SF-36) mental health | 77.7 units on a scale STANDARD_DEVIATION 13.7 | 78.4 units on a scale STANDARD_DEVIATION 15.1 | 78.08 units on a scale STANDARD_DEVIATION 14.41 |
| Short-Form 36-Item Health Survey (SF-36) physical functioning | 71.7 units on a scale STANDARD_DEVIATION 16.3 | 72.1 units on a scale STANDARD_DEVIATION 15.8 | 71.87 units on a scale STANDARD_DEVIATION 16.02 |
| Short-Form 36-Item Health Survey (SF-36) role emotional | 80.3 units on a scale STANDARD_DEVIATION 33.8 | 78.6 units on a scale STANDARD_DEVIATION 37.3 | 79.45 units on a scale STANDARD_DEVIATION 35.51 |
| Short-Form 36-Item Health Survey (SF-36) role physical | 35.7 units on a scale STANDARD_DEVIATION 36.8 | 33.5 units on a scale STANDARD_DEVIATION 39.2 | 34.59 units on a scale STANDARD_DEVIATION 37.96 |
| Short-Form 36-Item Health Survey (SF-36) social function | 76.1 units on a scale STANDARD_DEVIATION 22.1 | 79.6 units on a scale STANDARD_DEVIATION 21.9 | 77.85 units on a scale STANDARD_DEVIATION 22.02 |
| Short-Form 36-Item Health Survey (SF-36) vitality | 62.2 units on a scale STANDARD_DEVIATION 18.1 | 61.0 units on a scale STANDARD_DEVIATION 20.7 | 61.62 units on a scale STANDARD_DEVIATION 19.4 |
| Strength (dynamometer microFIT3) abduction | 18.0 pounds STANDARD_DEVIATION 9.8 | 18.0 pounds STANDARD_DEVIATION 9.8 | 18.0 pounds STANDARD_DEVIATION 9.7 |
| Strength (dynamometer microFIT3) External rotation in abduction | 11.9 pounds STANDARD_DEVIATION 9.3 | 11.2 pounds STANDARD_DEVIATION 8.3 | 11.54 pounds STANDARD_DEVIATION 8.8 |
| Strength (dynamometer microFIT3) flexion | 20.1 pounds STANDARD_DEVIATION 12.3 | 19.2 pounds STANDARD_DEVIATION 10.9 | 19.66 pounds STANDARD_DEVIATION 11.6 |
| Strength (dynamometer microFIT3) horizontal adduction | 20.2 pounds STANDARD_DEVIATION 13.3 | 17.4 pounds STANDARD_DEVIATION 11.8 | 18.8 pounds STANDARD_DEVIATION 12.6 |
| Strength (dynamometer microFIT3) internal rotation in abduction | 19.4 pounds STANDARD_DEVIATION 14 | 17.6 pounds STANDARD_DEVIATION 12.3 | 18.53 pounds STANDARD_DEVIATION 13.21 |
| Strength (dynamometer microFIT3) scaption | 14.14 pounds STANDARD_DEVIATION 7.55 | 13.99 pounds STANDARD_DEVIATION 6.92 | 14.07 pounds STANDARD_DEVIATION 7.23 |
| Surgical Characteristics Mean length of tear Anteroposterior | 2.1 cm STANDARD_DEVIATION 1 | 2.1 cm STANDARD_DEVIATION 1.1 | 2.1 cm STANDARD_DEVIATION 1.04 |
| Surgical Characteristics Mean length of tear Mediolateral | 1.9 cm STANDARD_DEVIATION 1.1 | 1.9 cm STANDARD_DEVIATION 1.1 | 1.9 cm STANDARD_DEVIATION 1.1 |
| Western Ontario Rotator Cuff Index (WORC) | 40.6 percentage STANDARD_DEVIATION 17.2 | 38.9 percentage STANDARD_DEVIATION 18.5 | 39.75 percentage STANDARD_DEVIATION 17.88 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 103 | 0 / 103 |
| other Total, other adverse events | 10 / 103 | 6 / 103 |
| serious Total, serious adverse events | 0 / 103 | 0 / 103 |
Outcome results
Primary
Range of Motion (ROM)
Measured 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
Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A (Early ROM) | Range of Motion (ROM) | Internal rotation in abduction 24 months | 40.9 degrees | Standard Deviation 12 |
| Group A (Early ROM) | Range of Motion (ROM) | External Rotation in Abduction Baseline | 62.2 degrees | Standard Deviation 34.1 |
| Group A (Early ROM) | Range of Motion (ROM) | Forward Flexion baseline | 131.5 degrees | Standard Deviation 30 |
| Group A (Early ROM) | Range of Motion (ROM) | Horizontal adduction 12 months | 19.1 degrees | Standard Deviation 10.4 |
| Group A (Early ROM) | Range of Motion (ROM) | Forward Flexion 6 weeks | 90.0 degrees | Standard Deviation 33.4 |
| Group A (Early ROM) | Range of Motion (ROM) | Internal rotation in abduction 6 months | 35.9 degrees | Standard Deviation 12.1 |
| Group A (Early ROM) | Range of Motion (ROM) | Forward Flexion 3 months | 125.5 degrees | Standard Deviation 28.5 |
| Group A (Early ROM) | Range of Motion (ROM) | Horizontal adduction 24 months | 20.4 degrees | Standard Deviation 10.5 |
| Group A (Early ROM) | Range of Motion (ROM) | Forward Flexion 6 months | 142.3 degrees | Standard Deviation 22.6 |
| Group A (Early ROM) | Range of Motion (ROM) | Horizontal adduction baseline | 13.2 degrees | Standard Deviation 9.2 |
| Group A (Early ROM) | Range of Motion (ROM) | Forward Flexion12 months | 150.9 degrees | Standard Deviation 12.6 |
| Group A (Early ROM) | Range of Motion (ROM) | Scaption baseline | 124.6 degrees | Standard Deviation 31.3 |
| Group A (Early ROM) | Range of Motion (ROM) | Forward Flexion 24 months | 155.5 degrees | Standard Deviation 12.7 |
| Group A (Early ROM) | Range of Motion (ROM) | Internal rotation in abduction 3 months | 30.2 degrees | Standard Deviation 15.2 |
| Group A (Early ROM) | Range of Motion (ROM) | Abduction baseline | 121.1 degrees | Standard Deviation 36 |
| Group A (Early ROM) | Range of Motion (ROM) | Scaption 6 weeks | 80.4 degrees | Standard Deviation 33.1 |
| Group A (Early ROM) | Range of Motion (ROM) | Abduction 6 weeks | 75.4 degrees | Standard Deviation 36.8 |
| Group A (Early ROM) | Range of Motion (ROM) | Horizontal adduction 6 weeks | 8.2 degrees | Standard Deviation 10 |
| Group A (Early ROM) | Range of Motion (ROM) | Abduction 3 months | 119.1 degrees | Standard Deviation 31.3 |
| Group A (Early ROM) | Range of Motion (ROM) | Scaption 3 months | 120.7 degrees | Standard Deviation 28 |
| Group A (Early ROM) | Range of Motion (ROM) | Abduction 6 months | 139.4 degrees | Standard Deviation 23.5 |
| Group A (Early ROM) | Range of Motion (ROM) | Internal rotation in abduction 12 months | 39.0 degrees | Standard Deviation 12.4 |
| Group A (Early ROM) | Range of Motion (ROM) | Abduction 12 months | 150.0 degrees | Standard Deviation 15.3 |
| Group A (Early ROM) | Range of Motion (ROM) | Scaption 6 months | 138.0 degrees | Standard Deviation 21.4 |
| Group A (Early ROM) | Range of Motion (ROM) | Abduction 24 months | 153.5 degrees | Standard Deviation 14.6 |
| Group A (Early ROM) | Range of Motion (ROM) | Horizontal adduction 3 months | 14.9 degrees | Standard Deviation 9.7 |
| Group A (Early ROM) | Range of Motion (ROM) | External Rotation in Abduction 6 weeks | 22.0 degrees | Standard Deviation 29.2 |
| Group A (Early ROM) | Range of Motion (ROM) | Scaption 12 months | 148.7 degrees | Standard Deviation 11.7 |
| Group A (Early ROM) | Range of Motion (ROM) | External Rotation in Abduction 3 months | 53.0 degrees | Standard Deviation 27.6 |
| Group A (Early ROM) | Range of Motion (ROM) | Internal rotation in abduction 6 weeks | 14.1 degrees | Standard Deviation 18.6 |
| Group A (Early ROM) | Range of Motion (ROM) | External Rotation in Abduction 6 months | 67.6 degrees | Standard Deviation 21 |
| Group A (Early ROM) | Range of Motion (ROM) | Scaption 24 months | 151.7 degrees | Standard Deviation 12.8 |
| Group A (Early ROM) | Range of Motion (ROM) | External Rotation in Abduction 12 months | 75.3 degrees | Standard Deviation 16.2 |
| Group A (Early ROM) | Range of Motion (ROM) | Horizontal adduction 6 months | 19.4 degrees | Standard Deviation 13.5 |
| Group A (Early ROM) | Range of Motion (ROM) | External Rotation in Abduction 24 months | 76.0 degrees | Standard Deviation 14.8 |
| Group A (Early ROM) | Range of Motion (ROM) | Internal rotation in abduction baseline | 30.6 degrees | Standard Deviation 18.6 |
| Group B (Usual Care) | Range of Motion (ROM) | External Rotation in Abduction 24 months | 71.5 degrees | Standard Deviation 17.8 |
| Group B (Usual Care) | Range of Motion (ROM) | Internal rotation in abduction baseline | 33.2 degrees | Standard Deviation 17.6 |
| Group B (Usual Care) | Range of Motion (ROM) | Internal rotation in abduction 6 weeks | 11.8 degrees | Standard Deviation 16.6 |
| Group B (Usual Care) | Range of Motion (ROM) | Internal rotation in abduction 3 months | 25.9 degrees | Standard Deviation 16.3 |
| Group B (Usual Care) | Range of Motion (ROM) | Internal rotation in abduction 6 months | 35.5 degrees | Standard Deviation 12.2 |
| Group B (Usual Care) | Range of Motion (ROM) | Internal rotation in abduction 12 months | 40.1 degrees | Standard Deviation 14.4 |
| Group B (Usual Care) | Range of Motion (ROM) | Internal rotation in abduction 24 months | 38.7 degrees | Standard Deviation 12.4 |
| Group B (Usual Care) | Range of Motion (ROM) | Horizontal adduction baseline | 14.4 degrees | Standard Deviation 10.3 |
| Group B (Usual Care) | Range of Motion (ROM) | Horizontal adduction 6 weeks | 6.4 degrees | Standard Deviation 9.3 |
| Group B (Usual Care) | Range of Motion (ROM) | Horizontal adduction 3 months | 13.0 degrees | Standard Deviation 9.7 |
| Group B (Usual Care) | Range of Motion (ROM) | Horizontal adduction 6 months | 18.1 degrees | Standard Deviation 9.9 |
| Group B (Usual Care) | Range of Motion (ROM) | Horizontal adduction 12 months | 18.9 degrees | Standard Deviation 10.4 |
| Group B (Usual Care) | Range of Motion (ROM) | Horizontal adduction 24 months | 19.5 degrees | Standard Deviation 11.5 |
| Group B (Usual Care) | Range of Motion (ROM) | Scaption baseline | 123.6 degrees | Standard Deviation 34.8 |
| Group B (Usual Care) | Range of Motion (ROM) | Scaption 6 weeks | 75.8 degrees | Standard Deviation 36.3 |
| Group B (Usual Care) | Range of Motion (ROM) | Scaption 3 months | 118.5 degrees | Standard Deviation 31 |
| Group B (Usual Care) | Range of Motion (ROM) | Scaption 6 months | 137.9 degrees | Standard Deviation 23.6 |
| Group B (Usual Care) | Range of Motion (ROM) | Scaption 12 months | 146.7 degrees | Standard Deviation 20.2 |
| Group B (Usual Care) | Range of Motion (ROM) | Scaption 24 months | 149.7 degrees | Standard Deviation 18.8 |
| Group B (Usual Care) | Range of Motion (ROM) | External Rotation in Abduction Baseline | 61.6 degrees | Standard Deviation 31.6 |
| Group B (Usual Care) | Range of Motion (ROM) | Forward Flexion baseline | 127.4 degrees | Standard Deviation 34.9 |
| Group B (Usual Care) | Range of Motion (ROM) | Forward Flexion 6 weeks | 78.9 degrees | Standard Deviation 34.5 |
| Group B (Usual Care) | Range of Motion (ROM) | Forward Flexion 3 months | 121.0 degrees | Standard Deviation 30.1 |
| Group B (Usual Care) | Range of Motion (ROM) | Forward Flexion 6 months | 141.3 degrees | Standard Deviation 22.6 |
| Group B (Usual Care) | Range of Motion (ROM) | Forward Flexion12 months | 149.0 degrees | Standard Deviation 19.9 |
| Group B (Usual Care) | Range of Motion (ROM) | Forward Flexion 24 months | 152.2 degrees | Standard Deviation 18.5 |
| Group B (Usual Care) | Range of Motion (ROM) | Abduction baseline | 118.6 degrees | Standard Deviation 39.4 |
| Group B (Usual Care) | Range of Motion (ROM) | Abduction 6 weeks | 67.1 degrees | Standard Deviation 32.9 |
| Group B (Usual Care) | Range of Motion (ROM) | Abduction 3 months | 116.0 degrees | Standard Deviation 37.6 |
| Group B (Usual Care) | Range of Motion (ROM) | Abduction 6 months | 139.5 degrees | Standard Deviation 27.6 |
| Group B (Usual Care) | Range of Motion (ROM) | Abduction 12 months | 148.4 degrees | Standard Deviation 22.4 |
| Group B (Usual Care) | Range of Motion (ROM) | Abduction 24 months | 152.2 degrees | Standard Deviation 21.9 |
| Group B (Usual Care) | Range of Motion (ROM) | External Rotation in Abduction 6 weeks | 19.5 degrees | Standard Deviation 28.8 |
| Group B (Usual Care) | Range of Motion (ROM) | External Rotation in Abduction 3 months | 44.2 degrees | Standard Deviation 28.8 |
| Group B (Usual Care) | Range of Motion (ROM) | External Rotation in Abduction 6 months | 62.9 degrees | Standard Deviation 21.6 |
| Group B (Usual Care) | Range of Motion (ROM) | External Rotation in Abduction 12 months | 70.6 degrees | Standard Deviation 18.8 |
Primary
Western Ontario Rotator Cuff Index (WORC)
a 5-part (physical symptoms, sports/recreation, work, lifestyle, emotions) 21-item disease specific questionnaire. Measured in percentage. 0% = worst, 100 % = best
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A (Early ROM) | Western Ontario Rotator Cuff Index (WORC) | Baseline | 39.2 percentage | Standard Deviation 18.4 |
| Group A (Early ROM) | Western Ontario Rotator Cuff Index (WORC) | 6 weeks | 44.5 percentage | Standard Deviation 16.6 |
| Group A (Early ROM) | Western Ontario Rotator Cuff Index (WORC) | 3 months | 61.4 percentage | Standard Deviation 19 |
| Group A (Early ROM) | Western Ontario Rotator Cuff Index (WORC) | 6 months | 78.6 percentage | Standard Deviation 16.8 |
| Group A (Early ROM) | Western Ontario Rotator Cuff Index (WORC) | 12 months | 87.6 percentage | Standard Deviation 14.1 |
| Group A (Early ROM) | Western Ontario Rotator Cuff Index (WORC) | 24 months | 89.4 percentage | Standard Deviation 13.4 |
| Group B (Usual Care) | Western Ontario Rotator Cuff Index (WORC) | 12 months | 88.6 percentage | Standard Deviation 13.1 |
| Group B (Usual Care) | Western Ontario Rotator Cuff Index (WORC) | Baseline | 40.2 percentage | Standard Deviation 17.3 |
| Group B (Usual Care) | Western Ontario Rotator Cuff Index (WORC) | 6 months | 79.6 percentage | Standard Deviation 15.2 |
| Group B (Usual Care) | Western Ontario Rotator Cuff Index (WORC) | 6 weeks | 40.7 percentage | Standard Deviation 14 |
| Group B (Usual Care) | Western Ontario Rotator Cuff Index (WORC) | 24 months | 89.8 percentage | Standard Deviation 13.4 |
| Group B (Usual Care) | Western Ontario Rotator Cuff Index (WORC) | 3 months | 63.7 percentage | Standard Deviation 17.6 |
Secondary
Adverse Events
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).
Time frame: 2 weeks, 6 weeks, 3 months, 6months
Population: Expected, surgical procedure related: superficial infection, frozen shoulder, biceps rupture, persistent pain, reinjury Unexpected, not treatment related: Traumatic reinjury
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A (Early ROM) | Adverse Events | Cardiac | 0 Participants |
| Group A (Early ROM) | Adverse Events | Persistent Pain | 10 Participants |
| Group A (Early ROM) | Adverse Events | Pulmonary | 0 Participants |
| Group A (Early ROM) | Adverse Events | Frozen Shoulder | 1 Participants |
| Group A (Early ROM) | Adverse Events | Metabolic | 0 Participants |
| Group A (Early ROM) | Adverse Events | Re-injury not requiring surgery | 5 Participants |
| Group A (Early ROM) | Adverse Events | Nerve Injury | 0 Participants |
| Group A (Early ROM) | Adverse Events | Dislocation | 0 Participants |
| Group A (Early ROM) | Adverse Events | Superficial Infection | 0 Participants |
| Group A (Early ROM) | Adverse Events | Hematoma | 0 Participants |
| Group A (Early ROM) | Adverse Events | Urinary | 0 Participants |
| Group A (Early ROM) | Adverse Events | Dermatitis | 0 Participants |
| Group A (Early ROM) | Adverse Events | Biceps Rupture | 1 Participants |
| Group A (Early ROM) | Adverse Events | Reflex Sympathetic Dystrophy (RSD) | 0 Participants |
| Group A (Early ROM) | Adverse Events | Gastrointestinal | 0 Participants |
| Group A (Early ROM) | Adverse Events | Traumatic Re-injury | 0 Participants |
| Group A (Early ROM) | Adverse Events | Deep infection | 0 Participants |
| Group B (Usual Care) | Adverse Events | Traumatic Re-injury | 2 Participants |
| Group B (Usual Care) | Adverse Events | Deep infection | 0 Participants |
| Group B (Usual Care) | Adverse Events | Superficial Infection | 1 Participants |
| Group B (Usual Care) | Adverse Events | Frozen Shoulder | 2 Participants |
| Group B (Usual Care) | Adverse Events | Biceps Rupture | 1 Participants |
| Group B (Usual Care) | Adverse Events | Persistent Pain | 6 Participants |
| Group B (Usual Care) | Adverse Events | Re-injury not requiring surgery | 4 Participants |
| Group B (Usual Care) | Adverse Events | Urinary | 0 Participants |
| Group B (Usual Care) | Adverse Events | Gastrointestinal | 0 Participants |
| Group B (Usual Care) | Adverse Events | Cardiac | 0 Participants |
| Group B (Usual Care) | Adverse Events | Pulmonary | 0 Participants |
| Group B (Usual Care) | Adverse Events | Metabolic | 0 Participants |
| Group B (Usual Care) | Adverse Events | Dislocation | 0 Participants |
| Group B (Usual Care) | Adverse Events | Hematoma | 0 Participants |
| Group B (Usual Care) | Adverse Events | Dermatitis | 0 Participants |
| Group B (Usual Care) | Adverse Events | Reflex Sympathetic Dystrophy (RSD) | 0 Participants |
| Group B (Usual Care) | Adverse Events | Nerve Injury | 0 Participants |
Secondary
Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months
Shoulder pain at rest, with activity and at night were measured using a visual analogue scale of 0-10 (no pain to severe pain)
Time frame: baseline, 6 weeks, 3, 6, 12, 24 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A (Early ROM) | Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months | Pain at rest - baseline | 3.1 centimeters | Standard Deviation 2.3 |
| Group A (Early ROM) | Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months | Pain at rest 6 weeks | 2.2 centimeters | Standard Deviation 2 |
| Group A (Early ROM) | 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 |
| Group A (Early ROM) | 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 |
| Group A (Early ROM) | Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months | Pain at rest 12 months | 0.6 centimeters | Standard Deviation 1 |
| Group A (Early ROM) | 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 |
| Group A (Early ROM) | Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months | Pain with activity - baseline | 6.1 centimeters | Standard Deviation 2.4 |
| Group A (Early ROM) | 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 |
| Group A (Early ROM) | 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 |
| Group A (Early ROM) | 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 |
| Group A (Early ROM) | 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 |
| Group A (Early ROM) | 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 |
| Group A (Early ROM) | Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months | Pain at night - baseline | 4.8 centimeters | Standard Deviation 2.6 |
| Group A (Early ROM) | 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 |
| Group A (Early ROM) | 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 |
| Group A (Early ROM) | 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 |
| Group A (Early ROM) | 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 |
| Group A (Early ROM) | 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 |
| Group B (Usual Care) | Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months | Pain at night 6 weeks | 2.8 centimeters | Standard Deviation 2.1 |
| Group B (Usual Care) | Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months | Pain at rest - baseline | 2.9 centimeters | Standard Deviation 2.4 |
| Group B (Usual Care) | Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months | Pain with activity 6 months | 1.8 centimeters | Standard Deviation 1.5 |
| Group B (Usual Care) | Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months | Pain at rest 6 weeks | 2.0 centimeters | Standard Deviation 1.9 |
| Group B (Usual Care) | Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months | Pain at night 24 months | 0.7 centimeters | Standard Deviation 1.4 |
| Group B (Usual Care) | Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months | Pain at rest 3 months | 1.4 centimeters | Standard Deviation 1.6 |
| Group B (Usual Care) | 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 |
| Group B (Usual Care) | Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months | Pain at rest 6 months | 0.8 centimeters | Standard Deviation 1 |
| Group B (Usual Care) | Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months | Pain at night 3 months | 2.1 centimeters | Standard Deviation 2 |
| Group B (Usual Care) | Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months | Pain at rest 12 months | 0.6 centimeters | Standard Deviation 1 |
| Group B (Usual Care) | Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months | Pain with activity 24 months | 1.0 centimeters | Standard Deviation 1.6 |
| Group B (Usual Care) | Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months | Pain at rest 24 months | 0.6 centimeters | Standard Deviation 1.3 |
| Group B (Usual Care) | Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months | Pain at night 12 months | 0.8 centimeters | Standard Deviation 1.4 |
| Group B (Usual Care) | Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months | Pain with activity - baseline | 5.8 centimeters | Standard Deviation 2.3 |
| Group B (Usual Care) | Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months | Pain at night - baseline | 4.4 centimeters | Standard Deviation 2.7 |
| Group B (Usual Care) | Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months | Pain with activity 6 weeks | 3.9 centimeters | Standard Deviation 2.1 |
| Group B (Usual Care) | Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months | Pain at night 6 months | 1.0 centimeters | Standard Deviation 1.2 |
| Group B (Usual Care) | Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months | Pain with activity 3 months | 2.8 centimeters | Standard Deviation 1.9 |
Secondary
Strength
strength 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.
Time frame: Baseline, 6 months, 12 months, 24 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A (Early ROM) | Strength | Abduction 12 months | 26.8 pounds | Standard Deviation 10.7 |
| Group A (Early ROM) | Strength | Flexion 6 months | 26.3 pounds | Standard Deviation 12.6 |
| Group A (Early ROM) | Strength | Flexion 12 months | 29.7 pounds | Standard Deviation 13.7 |
| Group A (Early ROM) | Strength | Flexion 24 months | 28.3 pounds | Standard Deviation 11.5 |
| Group A (Early ROM) | Strength | Abduction baseline | 18.6 pounds | Standard Deviation 10 |
| Group A (Early ROM) | Strength | Abduction 6 months | 23.2 pounds | Standard Deviation 10.1 |
| Group A (Early ROM) | Strength | Flexion baseline | 19.6 pounds | Standard Deviation 10.9 |
| Group A (Early ROM) | Strength | Abduction 24 months | 26.9 pounds | Standard Deviation 9.6 |
| Group A (Early ROM) | Strength | External rotation in abduction baseline | 11.5 pounds | Standard Deviation 8.4 |
| Group A (Early ROM) | Strength | External rotation in abduction 6 months | 18.2 pounds | Standard Deviation 9.4 |
| Group A (Early ROM) | Strength | External rotation in abduction 12 months | 23.3 pounds | Standard Deviation 12.5 |
| Group A (Early ROM) | Strength | External rotation in abduction 24 months | 25.1 pounds | Standard Deviation 12.5 |
| Group A (Early ROM) | Strength | Internal rotation in abduction baseline | 18.1 pounds | Standard Deviation 12.7 |
| Group A (Early ROM) | Strength | Internal rotation in abduction 6 months | 27.1 pounds | Standard Deviation 14.5 |
| Group A (Early ROM) | Strength | Internal rotation in abduction 12 months | 30.9 pounds | Standard Deviation 15.2 |
| Group A (Early ROM) | Strength | Internal rotation in abduction 24 months | 30.6 pounds | Standard Deviation 13.1 |
| Group A (Early ROM) | Strength | Horizontal Adduction baseline | 17.7 pounds | Standard Deviation 12.2 |
| Group A (Early ROM) | Strength | Horizontal Adduction 6 months | 25.7 pounds | Standard Deviation 12.1 |
| Group A (Early ROM) | Strength | Horizontal Adduction 12 months | 28.1 pounds | Standard Deviation 11.3 |
| Group A (Early ROM) | Strength | Horizontal Adduction 24 months | 27.9 pounds | Standard Deviation 9.8 |
| Group A (Early ROM) | Strength | Scaption baseline | 14.2 pounds | Standard Deviation 7.1 |
| Group A (Early ROM) | Strength | Scaption 6 months | 16.4 pounds | Standard Deviation 6.9 |
| Group A (Early ROM) | Strength | Scaption 12 months | 19.8 pounds | Standard Deviation 7.3 |
| Group A (Early ROM) | Strength | Scaption 24 months | 20.6 pounds | Standard Deviation 7 |
| Group B (Usual Care) | Strength | Scaption 12 months | 19.1 pounds | Standard Deviation 7 |
| Group B (Usual Care) | Strength | Flexion baseline | 19.8 pounds | Standard Deviation 12.3 |
| Group B (Usual Care) | Strength | Internal rotation in abduction baseline | 19.5 pounds | Standard Deviation 14.1 |
| Group B (Usual Care) | Strength | Flexion 6 months | 27.1 pounds | Standard Deviation 10.8 |
| Group B (Usual Care) | Strength | Horizontal Adduction 12 months | 28.4 pounds | Standard Deviation 11.6 |
| Group B (Usual Care) | Strength | Flexion 12 months | 31.0 pounds | Standard Deviation 12.7 |
| Group B (Usual Care) | Strength | Internal rotation in abduction 6 months | 26.7 pounds | Standard Deviation 12.5 |
| Group B (Usual Care) | Strength | Flexion 24 months | 29.1 pounds | Standard Deviation 11.7 |
| Group B (Usual Care) | Strength | Scaption 6 months | 16.3 pounds | Standard Deviation 6.5 |
| Group B (Usual Care) | Strength | Abduction baseline | 17.8 pounds | Standard Deviation 10.1 |
| Group B (Usual Care) | Strength | Internal rotation in abduction 12 months | 32.3 pounds | Standard Deviation 14.4 |
| Group B (Usual Care) | Strength | Abduction 6 months | 23.2 pounds | Standard Deviation 9.3 |
| Group B (Usual Care) | Strength | Horizontal Adduction 24 months | 28.2 pounds | Standard Deviation 11.1 |
| Group B (Usual Care) | Strength | Abduction 12 months | 26.9 pounds | Standard Deviation 10.5 |
| Group B (Usual Care) | Strength | Internal rotation in abduction 24 months | 31.3 pounds | Standard Deviation 13.4 |
| Group B (Usual Care) | Strength | Abduction 24 months | 28.2 pounds | Standard Deviation 10.6 |
| Group B (Usual Care) | Strength | Scaption 24 months | 19.7 pounds | Standard Deviation 7.2 |
| Group B (Usual Care) | Strength | External rotation in abduction baseline | 11.9 pounds | Standard Deviation 9.6 |
| Group B (Usual Care) | Strength | Horizontal Adduction baseline | 20.0 pounds | Standard Deviation 13.4 |
| Group B (Usual Care) | Strength | External rotation in abduction 6 months | 18.7 pounds | Standard Deviation 10.1 |
| Group B (Usual Care) | Strength | Scaption baseline | 13.9 pounds | Standard Deviation 7.2 |
| Group B (Usual Care) | Strength | External rotation in abduction 12 months | 24.0 pounds | Standard Deviation 12.3 |
| Group B (Usual Care) | Strength | Horizontal Adduction 6 months | 25.4 pounds | Standard Deviation 10.7 |
| Group B (Usual Care) | Strength | External rotation in abduction 24 months | 24.8 pounds | Standard Deviation 11.8 |
Secondary
The Short Form (36) Health Survey
The 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).
Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A (Early ROM) | The Short Form (36) Health Survey | physical functioning 6 weeks | 68.2 units on a scale | Standard Deviation 14.2 |
| Group A (Early ROM) | The Short Form (36) Health Survey | Vitality baseline | 61.0 units on a scale | Standard Deviation 20.3 |
| Group A (Early ROM) | The Short Form (36) Health Survey | bodily pain baseline | 43.5 units on a scale | Standard Deviation 16.4 |
| Group A (Early ROM) | The Short Form (36) Health Survey | Vitality 6 weeks | 58.9 units on a scale | Standard Deviation 18.8 |
| Group A (Early ROM) | The Short Form (36) Health Survey | role physical baseline | 33.2 units on a scale | Standard Deviation 39.1 |
| Group A (Early ROM) | The Short Form (36) Health Survey | Vitality 3 months | 65.9 units on a scale | Standard Deviation 18.1 |
| Group A (Early ROM) | The Short Form (36) Health Survey | bodily pain 6 weeks | 50.2 units on a scale | Standard Deviation 22.8 |
| Group A (Early ROM) | The Short Form (36) Health Survey | Vitality 6 months | 70.4 units on a scale | Standard Deviation 15.4 |
| Group A (Early ROM) | The Short Form (36) Health Survey | physical functioning 6 months | 84.4 units on a scale | Standard Deviation 14.1 |
| Group A (Early ROM) | The Short Form (36) Health Survey | Vitality 12 months | 73.2 units on a scale | Standard Deviation 15.4 |
| Group A (Early ROM) | The Short Form (36) Health Survey | bodily pain 3 months | 62.5 units on a scale | Standard Deviation 22.5 |
| Group A (Early ROM) | The Short Form (36) Health Survey | Vitality 24 months | 70.7 units on a scale | Standard Deviation 19.9 |
| Group A (Early ROM) | The Short Form (36) Health Survey | Mental health 12 months | 82.8 units on a scale | Standard Deviation 15 |
| Group A (Early ROM) | The Short Form (36) Health Survey | Social function baseline | 79.0 units on a scale | Standard Deviation 22.2 |
| Group A (Early ROM) | The Short Form (36) Health Survey | role physical 6 weeks | 14.7 units on a scale | Standard Deviation 28.8 |
| Group A (Early ROM) | The Short Form (36) Health Survey | Social function 6 weeks | 70.0 units on a scale | Standard Deviation 26.3 |
| Group A (Early ROM) | The Short Form (36) Health Survey | bodily pain 6 months | 69.5 units on a scale | Standard Deviation 17.8 |
| Group A (Early ROM) | The Short Form (36) Health Survey | Social function 3 months | 82.4 units on a scale | Standard Deviation 20 |
| Group A (Early ROM) | The Short Form (36) Health Survey | physical functioning baseline | 72.8 units on a scale | Standard Deviation 15.2 |
| Group A (Early ROM) | The Short Form (36) Health Survey | Social function 6 months | 90.5 units on a scale | Standard Deviation 16.5 |
| Group A (Early ROM) | The Short Form (36) Health Survey | bodily pain 12 months | 74.6 units on a scale | Standard Deviation 20 |
| Group A (Early ROM) | The Short Form (36) Health Survey | Social function 12 months | 90.4 units on a scale | Standard Deviation 17.1 |
| Group A (Early ROM) | The Short Form (36) Health Survey | role physical 3 months | 40.9 units on a scale | Standard Deviation 42.7 |
| Group A (Early ROM) | The Short Form (36) Health Survey | Social function 24 months | 86.4 units on a scale | Standard Deviation 21.3 |
| Group A (Early ROM) | The Short Form (36) Health Survey | bodily pain 24 months | 73.2 units on a scale | Standard Deviation 22.2 |
| Group A (Early ROM) | The Short Form (36) Health Survey | role emotional baseline | 80.2 units on a scale | Standard Deviation 36.2 |
| Group A (Early ROM) | The Short Form (36) Health Survey | physical functioning 12 months | 89.3 units on a scale | Standard Deviation 13.2 |
| Group A (Early ROM) | The Short Form (36) Health Survey | role emotional 6 weeks | 65.9 units on a scale | Standard Deviation 42.7 |
| Group A (Early ROM) | The Short Form (36) Health Survey | General Health baseline | 79.0 units on a scale | Standard Deviation 15.4 |
| Group A (Early ROM) | The Short Form (36) Health Survey | role emotional 3 months | 78.0 units on a scale | Standard Deviation 37.6 |
| Group A (Early ROM) | The Short Form (36) Health Survey | role physical 6 months | 71.1 units on a scale | Standard Deviation 37.6 |
| Group A (Early ROM) | The Short Form (36) Health Survey | role emotional 6 months | 89.4 units on a scale | Standard Deviation 26.7 |
| Group A (Early ROM) | The Short Form (36) Health Survey | General Health 6 weeks | 78.0 units on a scale | Standard Deviation 17.1 |
| Group A (Early ROM) | The Short Form (36) Health Survey | role emotional 12 months | 90.7 units on a scale | Standard Deviation 25.8 |
| Group A (Early ROM) | The Short Form (36) Health Survey | physical functioning 3 months | 75.0 units on a scale | Standard Deviation 15.9 |
| Group A (Early ROM) | The Short Form (36) Health Survey | role emotional 24 months | 92.2 units on a scale | Standard Deviation 20.9 |
| Group A (Early ROM) | The Short Form (36) Health Survey | General Health 3 months | 77.6 units on a scale | Standard Deviation 14.7 |
| Group A (Early ROM) | The Short Form (36) Health Survey | Mental health baseline | 79.0 units on a scale | Standard Deviation 13.9 |
| Group A (Early ROM) | The Short Form (36) Health Survey | role physical 12 months | 86.1 units on a scale | Standard Deviation 29.6 |
| Group A (Early ROM) | The Short Form (36) Health Survey | Mental health 6 weeks | 79.5 units on a scale | Standard Deviation 15.6 |
| Group A (Early ROM) | The Short Form (36) Health Survey | General Health 6 months | 81.1 units on a scale | Standard Deviation 13.5 |
| Group A (Early ROM) | The Short Form (36) Health Survey | Mental health 3 months | 79.8 units on a scale | Standard Deviation 15.8 |
| Group A (Early ROM) | The Short Form (36) Health Survey | physical functioning 24 months | 86.8 units on a scale | Standard Deviation 15.4 |
| Group A (Early ROM) | The Short Form (36) Health Survey | Mental health 6 months | 81.9 units on a scale | Standard Deviation 13.8 |
| Group A (Early ROM) | The Short Form (36) Health Survey | General Health 12 months | 80.3 units on a scale | Standard Deviation 14.6 |
| Group A (Early ROM) | The Short Form (36) Health Survey | role physical 24 months | 81.8 units on a scale | Standard Deviation 33.6 |
| Group A (Early ROM) | The Short Form (36) Health Survey | Mental health 24 months | 81.4 units on a scale | Standard Deviation 14.8 |
| Group A (Early ROM) | The Short Form (36) Health Survey | General Health 24 months | 78.8 units on a scale | Standard Deviation 17.3 |
| Group B (Usual Care) | The Short Form (36) Health Survey | Vitality 24 months | 73.9 units on a scale | Standard Deviation 16.3 |
| Group B (Usual Care) | The Short Form (36) Health Survey | physical functioning baseline | 71.3 units on a scale | Standard Deviation 16.7 |
| Group B (Usual Care) | The Short Form (36) Health Survey | physical functioning 6 weeks | 64.7 units on a scale | Standard Deviation 15.2 |
| Group B (Usual Care) | The Short Form (36) Health Survey | physical functioning 3 months | 73.7 units on a scale | Standard Deviation 16.3 |
| Group B (Usual Care) | The Short Form (36) Health Survey | physical functioning 6 months | 82.7 units on a scale | Standard Deviation 18.1 |
| Group B (Usual Care) | The Short Form (36) Health Survey | physical functioning 12 months | 86.3 units on a scale | Standard Deviation 18.2 |
| Group B (Usual Care) | The Short Form (36) Health Survey | physical functioning 24 months | 85.7 units on a scale | Standard Deviation 16.9 |
| Group B (Usual Care) | The Short Form (36) Health Survey | role physical baseline | 36.6 units on a scale | Standard Deviation 37.7 |
| Group B (Usual Care) | The Short Form (36) Health Survey | role physical 6 weeks | 10.6 units on a scale | Standard Deviation 25.4 |
| Group B (Usual Care) | The Short Form (36) Health Survey | role physical 3 months | 37.5 units on a scale | Standard Deviation 41.2 |
| Group B (Usual Care) | The Short Form (36) Health Survey | role physical 6 months | 65.6 units on a scale | Standard Deviation 40.2 |
| Group B (Usual Care) | The Short Form (36) Health Survey | role physical 12 months | 79.8 units on a scale | Standard Deviation 35.8 |
| Group B (Usual Care) | The Short Form (36) Health Survey | role physical 24 months | 74.4 units on a scale | Standard Deviation 38.8 |
| Group B (Usual Care) | The Short Form (36) Health Survey | bodily pain baseline | 46.3 units on a scale | Standard Deviation 18.6 |
| Group B (Usual Care) | The Short Form (36) Health Survey | bodily pain 6 weeks | 45.5 units on a scale | Standard Deviation 24 |
| Group B (Usual Care) | The Short Form (36) Health Survey | bodily pain 3 months | 66.5 units on a scale | Standard Deviation 20.5 |
| Group B (Usual Care) | The Short Form (36) Health Survey | bodily pain 6 months | 71.7 units on a scale | Standard Deviation 19.2 |
| Group B (Usual Care) | The Short Form (36) Health Survey | bodily pain 12 months | 75.5 units on a scale | Standard Deviation 20.8 |
| Group B (Usual Care) | The Short Form (36) Health Survey | bodily pain 24 months | 76.7 units on a scale | Standard Deviation 22.7 |
| Group B (Usual Care) | The Short Form (36) Health Survey | General Health baseline | 76.0 units on a scale | Standard Deviation 17.9 |
| Group B (Usual Care) | The Short Form (36) Health Survey | General Health 6 weeks | 77.7 units on a scale | Standard Deviation 17 |
| Group B (Usual Care) | The Short Form (36) Health Survey | General Health 3 months | 79.3 units on a scale | Standard Deviation 17 |
| Group B (Usual Care) | The Short Form (36) Health Survey | General Health 6 months | 79.7 units on a scale | Standard Deviation 15.4 |
| Group B (Usual Care) | The Short Form (36) Health Survey | General Health 12 months | 80.1 units on a scale | Standard Deviation 15.7 |
| Group B (Usual Care) | The Short Form (36) Health Survey | General Health 24 months | 77.2 units on a scale | Standard Deviation 20 |
| Group B (Usual Care) | The Short Form (36) Health Survey | Vitality baseline | 63.2 units on a scale | Standard Deviation 18.2 |
| Group B (Usual Care) | The Short Form (36) Health Survey | Vitality 6 weeks | 57.3 units on a scale | Standard Deviation 19.2 |
| Group B (Usual Care) | The Short Form (36) Health Survey | Vitality 3 months | 68.0 units on a scale | Standard Deviation 16.7 |
| Group B (Usual Care) | The Short Form (36) Health Survey | Vitality 6 months | 72.9 units on a scale | Standard Deviation 14 |
| Group B (Usual Care) | The Short Form (36) Health Survey | Vitality 12 months | 73.9 units on a scale | Standard Deviation 14 |
| Group B (Usual Care) | The Short Form (36) Health Survey | Social function baseline | 76.5 units on a scale | Standard Deviation 22.1 |
| Group B (Usual Care) | The Short Form (36) Health Survey | Social function 6 weeks | 61.7 units on a scale | Standard Deviation 26.1 |
| Group B (Usual Care) | The Short Form (36) Health Survey | Social function 3 months | 81.1 units on a scale | Standard Deviation 20.6 |
| Group B (Usual Care) | The Short Form (36) Health Survey | Social function 6 months | 90.4 units on a scale | Standard Deviation 15.4 |
| Group B (Usual Care) | The Short Form (36) Health Survey | Social function 12 months | 91.1 units on a scale | Standard Deviation 17.2 |
| Group B (Usual Care) | The Short Form (36) Health Survey | Social function 24 months | 88.7 units on a scale | Standard Deviation 18.8 |
| Group B (Usual Care) | The Short Form (36) Health Survey | role emotional baseline | 81.4 units on a scale | Standard Deviation 33.9 |
| Group B (Usual Care) | The Short Form (36) Health Survey | role emotional 6 weeks | 64.2 units on a scale | Standard Deviation 43 |
| Group B (Usual Care) | The Short Form (36) Health Survey | role emotional 3 months | 74.5 units on a scale | Standard Deviation 38.4 |
| Group B (Usual Care) | The Short Form (36) Health Survey | role emotional 6 months | 82.8 units on a scale | Standard Deviation 34.5 |
| Group B (Usual Care) | The Short Form (36) Health Survey | role emotional 12 months | 89.3 units on a scale | Standard Deviation 25.3 |
| Group B (Usual Care) | The Short Form (36) Health Survey | role emotional 24 months | 88.2 units on a scale | Standard Deviation 27.5 |
| Group B (Usual Care) | The Short Form (36) Health Survey | Mental health baseline | 78.5 units on a scale | Standard Deviation 13.4 |
| Group B (Usual Care) | The Short Form (36) Health Survey | Mental health 6 weeks | 76.3 units on a scale | Standard Deviation 15.4 |
| Group B (Usual Care) | The Short Form (36) Health Survey | Mental health 3 months | 82.4 units on a scale | Standard Deviation 12.8 |
| Group B (Usual Care) | The Short Form (36) Health Survey | Mental health 6 months | 83.9 units on a scale | Standard Deviation 12.4 |
| Group B (Usual Care) | The Short Form (36) Health Survey | Mental health 12 months | 83.1 units on a scale | Standard Deviation 12.2 |
| Group B (Usual Care) | The Short Form (36) Health Survey | Mental health 24 months | 84.1 units on a scale | Standard Deviation 12 |