Full Thickness Rotator Cuff Tears
Conditions
Keywords
rotator cuff tear, arthroscopically assisted, health related quality of life(HRQL), functional outcome
Brief summary
The primary objective of this study is to determine if early active range of motion after mini-open rotator cuff repair in adults results in improved shoulder range of motion at 6 weeks and 3 months after surgery. The secondary objective of this study is to determine if early mobilization improves disease-specific quality of life and promotes earlier return to work/function. Hypothesis: Adults undergoing mini-open rotator cuff repair will have faster recovery of range of motion, improved disease specific quality of life and earlier return to work/function if allowed to begin early active range of motion compared to subjects who are immobilized in a sling for 6 weeks.
Detailed description
The rotator cuff is a group of four muscles around the shoulder. They function to provide both shoulder mobility and power as well as stability. Rotator cuff tears can be a significant cause of pain and disability for the patient. Surgical repair is done to reconnect the torn tendon(s) to the bone and has been shown to be an effective treatment in the presence of full-thickness tears. The goals of Rotator Cuff (RC)surgery are to decrease pain, increase range of motion(ROM) and strength. This is done with a small incision called a mini-open. Standard care following this surgical repair is to be placed in a sling for 6 weeks to protect the repaired shoulder tendons. During this time ROM exercises are done using the non-operated arm for assistance. No active or voluntary movement is allowed during the first 6 weeks. Unfortunately, some of these patients develop shoulder stiffness which slows their recovery and return to work or daily activities and may result in increased use and cost of rehabilitation services. The purpose of this study is to determine if following a RC repair, patients can safely stop wearing their sling and begin active ROM for activities of daily living as early as pain and comfort allow. A total of 190 patients have been recruited to this study (95/group) were randomly assigned to one of two study groups. Patients in Group A (sling for 6 weeks) will wear their sling for 6 weeks. Self-assisted ROM exercises are allowed at any time, but active movement will not be allowed until 6 weeks after surgery. Patients in Group B (Sling as needed) will be allowed to remove their sling as early as pain and comfort allow. Self-assisted ROM exercises are allowed at any time as are active ROM for activities of daily living. Patients who agree to participate will be seen by their surgeon and the research coordinator for a baseline assessment before surgery and again at 2 & 6 weeks, 3, 6, 12 and 24 months after surgery. Each visit will include a ROM assessment and disease specific quality of life questionnaires. Patients will also undergo an Ultrasound exam at a minimum of 2 years after surgery to verify the integrity of their RC repair. Differences in ROM, questionnaire scores, RC integrity and adverse events will be examined between the two groups.
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
Clinical: * males and females over 18 years of age * failed non-operative management defined as persistent pain and/or disability following 3 months of conservative medical treatment including analgesic/anti-inflammatory medications, intra-articular corticosteroids, activity modification and physical therapy. Radiological: * confirmed full-thickness rotator cuff tear on arthrogram or MRI Surgical: * full-thickness tear of the rotator cuff confirmed through arthroscopy * rotator cuff repairable using mini-open approach
Exclusion criteria
* previous shoulder surgery * previous fracture of scapula or humerus * history of charcot joint or inflammatory arthropathy * cervical radiculopathy * active joint or systemic infection * neurological disorder * significant paralysis of the rotator cuff, deltoid or shoulder girdle musculature * major medical illness (life expectancy less than 2 years or unacceptably high operative risk) * unable to speak or read English * immunosuppressive therapy or chronic steroids (eg. prednisone) * patient unwilling to be followed for 2 years * psychiatric illness that precludes informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Range of Motion (ROM)From Baseline to 24 Months | Baseline, 6 weeks, 3, 6, 12, 24 months | Two-way repeated-measures analysis of variance (ANOVA) compared shoulder ROM between groups over time. Standing: Active flexion, scaption, abduction, extension, internal rotation (vertebral level). Supine Lying: Active and passive flexion, abduction, external rotation (arm at side), external rotation (arm at 90 degrees abduction), internal rotation (arm at side), internal rotation (arm at 90 degrees abduction),and horizontal adduction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Questionnaire | Baseline, 2 weeks, 6 weeks, 3, 6, 12, 24 months | Shoulder pain was assessed using a visual analogue scale (VAS) where zero equals no pain and 10 is the worst possible pain at rest and with activity. Two-way repeated-measures analysis of variance (ANOVA) compared pain between groups over time. |
| WORC Questionnaire | Baseline, 6, 12, 24 months | Health related quality of life was measured using the Western Ontario Rotator Cuff Index (WORC). It is a 21-item disease specific questionnaire representing five quality of life domains (physical symptoms, sports and recreation, work, lifestyle and emotions). Each response is marked on a 100mm line in a VAS format with a maximum raw score of 2100, where zero represents the best and 2100 the worst score. This score is transformed to a 0-100 format, with 100 representing full shoulder function. |
| Abduction Strength Using the Power Component of the Constant Score | Baseline, 24 months | The Constant Score is the most widely used shoulder evaluation questionnaire in Europe and is a shoulder specific instrument. The score is a combination of an objective physical examination (65 points) and a subjective patient self evaluation (35 points). The physical examination component includes a range of motion assessment (forward elevation, lateral elevation, internal rotation, and external rotation) worth a total of 40 points (maximum of 10 points for each motion). The remaining 25 points are attributed to the strength assessment, where patients are awarded one point for each pound of pull that the patient can resist in abduction. Therefore the total possible score on the Constant score is 100 points (best possible score = 100. In this case only the power component was used therefore the best score is 25. |
| Complications | 2 & 6 weeks, 3, 6, 12, 24 months | Incidence of any surgical or medical complications will be prospectively documented. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A (Usual Care) Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling
Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed. | 92 |
| Group B (Early ROM) Will use the sling for comfort only. Intervention: Procedure: No sling
No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living. | 97 |
| Total | 189 |
Baseline characteristics
| Characteristic | Group A (Usual Care) | Group B (Early ROM) | Total |
|---|---|---|---|
| Age, Continuous | 54.9 years | 55.4 years | 55.1 years |
| Region of Enrollment Canada | 92 participants | 97 participants | 189 participants |
| Sex: Female, Male Female | 34 Participants | 40 Participants | 74 Participants |
| Sex: Female, Male Male | 58 Participants | 57 Participants | 115 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 20 / 92 | 17 / 97 |
| serious Total, serious adverse events | 0 / 92 | 0 / 97 |
Outcome results
Primary
Change in Range of Motion (ROM)From Baseline to 24 Months
Two-way repeated-measures analysis of variance (ANOVA) compared shoulder ROM between groups over time. Standing: Active flexion, scaption, abduction, extension, internal rotation (vertebral level). Supine Lying: Active and passive flexion, abduction, external rotation (arm at side), external rotation (arm at 90 degrees abduction), internal rotation (arm at side), internal rotation (arm at 90 degrees abduction),and horizontal adduction.
Time frame: Baseline, 6 weeks, 3, 6, 12, 24 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A (Usual Care) | Change in Range of Motion (ROM)From Baseline to 24 Months | Baseline Forward Flexion | 124.4 degrees | Standard Deviation 33.9 |
| Group A (Usual Care) | Change in Range of Motion (ROM)From Baseline to 24 Months | 6 months Internal Rotation in Abduction | 32.9 degrees | Standard Deviation 12 |
| Group A (Usual Care) | Change in Range of Motion (ROM)From Baseline to 24 Months | 6 weeks Forward Flexion | 73.2 degrees | Standard Deviation 32.1 |
| Group A (Usual Care) | Change in Range of Motion (ROM)From Baseline to 24 Months | 3 months Forward Flexion | 118.5 degrees | Standard Deviation 25.5 |
| Group A (Usual Care) | Change in Range of Motion (ROM)From Baseline to 24 Months | 6 months Forward Flexion | 135.9 degrees | Standard Deviation 21.6 |
| Group A (Usual Care) | Change in Range of Motion (ROM)From Baseline to 24 Months | 12 months Forward Flexion | 144.8 degrees | Standard Deviation 19.2 |
| Group A (Usual Care) | Change in Range of Motion (ROM)From Baseline to 24 Months | 24 months Forward Flexion | 149.6 degrees | Standard Deviation 17.8 |
| Group A (Usual Care) | Change in Range of Motion (ROM)From Baseline to 24 Months | Baseline Abduction | 117.4 degrees | Standard Deviation 40.1 |
| Group A (Usual Care) | Change in Range of Motion (ROM)From Baseline to 24 Months | 6 weeks Abduction | 68.5 degrees | Standard Deviation 27.8 |
| Group A (Usual Care) | Change in Range of Motion (ROM)From Baseline to 24 Months | 3 months Abduction | 113.0 degrees | Standard Deviation 26.2 |
| Group A (Usual Care) | Change in Range of Motion (ROM)From Baseline to 24 Months | 6 months Abduction | 139.1 degrees | Standard Deviation 25.8 |
| Group A (Usual Care) | Change in Range of Motion (ROM)From Baseline to 24 Months | 12 months Abduction | 149.9 degrees | Standard Deviation 23.2 |
| Group A (Usual Care) | Change in Range of Motion (ROM)From Baseline to 24 Months | 24 months Abduction | 155.5 degrees | Standard Deviation 20.2 |
| Group A (Usual Care) | Change in Range of Motion (ROM)From Baseline to 24 Months | Baseline External Rotation in Abduction | 65.2 degrees | Standard Deviation 35.6 |
| Group A (Usual Care) | Change in Range of Motion (ROM)From Baseline to 24 Months | 6 weeks External Rotation in Abduction | 15.0 degrees | Standard Deviation 28.2 |
| Group A (Usual Care) | Change in Range of Motion (ROM)From Baseline to 24 Months | 3 months External Rotation in Abduction | 53.7 degrees | Standard Deviation 26.9 |
| Group A (Usual Care) | Change in Range of Motion (ROM)From Baseline to 24 Months | 6 months External Rotation in Abduction | 74.2 degrees | Standard Deviation 17.1 |
| Group A (Usual Care) | Change in Range of Motion (ROM)From Baseline to 24 Months | 12 months External Rotation in Abduction | 80.3 degrees | Standard Deviation 13.9 |
| Group A (Usual Care) | Change in Range of Motion (ROM)From Baseline to 24 Months | 24 monthsExternal Rotation in Abduction | 84.0 degrees | Standard Deviation 11.9 |
| Group A (Usual Care) | Change in Range of Motion (ROM)From Baseline to 24 Months | Baseline Internal Rotation in Abduction | 30.7 degrees | Standard Deviation 19.9 |
| Group A (Usual Care) | Change in Range of Motion (ROM)From Baseline to 24 Months | 6 weeks Internal Rotation in Abduction | 7.7 degrees | Standard Deviation 14.4 |
| Group A (Usual Care) | Change in Range of Motion (ROM)From Baseline to 24 Months | 3 months Internal Rotation in Abduction | 24.1 degrees | Standard Deviation 13.8 |
| Group A (Usual Care) | Change in Range of Motion (ROM)From Baseline to 24 Months | 12 months Internal Rotation in Abduction | 34.8 degrees | Standard Deviation 10.3 |
| Group A (Usual Care) | Change in Range of Motion (ROM)From Baseline to 24 Months | 24 months Internal Rotation in Abduction | 35.7 degrees | Standard Deviation 10.2 |
| Group A (Usual Care) | Change in Range of Motion (ROM)From Baseline to 24 Months | Baseline Horizontal Adduction | 16.9 degrees | Standard Deviation 14.2 |
| Group A (Usual Care) | Change in Range of Motion (ROM)From Baseline to 24 Months | 6 weeks Horizontal Adduction | 5.9 degrees | Standard Deviation 9.1 |
| Group A (Usual Care) | Change in Range of Motion (ROM)From Baseline to 24 Months | 3 months Horizontal Adduction | 14.2 degrees | Standard Deviation 9.7 |
| Group A (Usual Care) | Change in Range of Motion (ROM)From Baseline to 24 Months | 6 months Horizontal Adduction | 17.6 degrees | Standard Deviation 9 |
| Group A (Usual Care) | Change in Range of Motion (ROM)From Baseline to 24 Months | 12 months Horizontal Adduction | 17.1 degrees | Standard Deviation 8 |
| Group A (Usual Care) | Change in Range of Motion (ROM)From Baseline to 24 Months | 24 months Horizontal Adduction | 15.1 degrees | Standard Deviation 6 |
| Group A (Usual Care) | Change in Range of Motion (ROM)From Baseline to 24 Months | Baseline Scaption | 123.8 degrees | Standard Deviation 36.1 |
| Group A (Usual Care) | Change in Range of Motion (ROM)From Baseline to 24 Months | 6 weeks Scaption | 72.1 degrees | Standard Deviation 31.8 |
| Group A (Usual Care) | Change in Range of Motion (ROM)From Baseline to 24 Months | 3 months Scaption | 121.6 degrees | Standard Deviation 26.9 |
| Group A (Usual Care) | Change in Range of Motion (ROM)From Baseline to 24 Months | 6 months Scaption | 140.3 degrees | Standard Deviation 22.1 |
| Group A (Usual Care) | Change in Range of Motion (ROM)From Baseline to 24 Months | 12 months Scaption | 149.1 degrees | Standard Deviation 18.4 |
| Group A (Usual Care) | Change in Range of Motion (ROM)From Baseline to 24 Months | 24 months Scaption | 151.0 degrees | Standard Deviation 17.7 |
| Group B (Early ROM) | Change in Range of Motion (ROM)From Baseline to 24 Months | 6 weeks Scaption | 86.1 degrees | Standard Deviation 30.7 |
| Group B (Early ROM) | Change in Range of Motion (ROM)From Baseline to 24 Months | 24 monthsExternal Rotation in Abduction | 81.5 degrees | Standard Deviation 11.7 |
| Group B (Early ROM) | Change in Range of Motion (ROM)From Baseline to 24 Months | Baseline Forward Flexion | 120.2 degrees | Standard Deviation 30.2 |
| Group B (Early ROM) | Change in Range of Motion (ROM)From Baseline to 24 Months | 6 months Horizontal Adduction | 16.2 degrees | Standard Deviation 8.4 |
| Group B (Early ROM) | Change in Range of Motion (ROM)From Baseline to 24 Months | 6 weeks Forward Flexion | 84.1 degrees | Standard Deviation 30.2 |
| Group B (Early ROM) | Change in Range of Motion (ROM)From Baseline to 24 Months | Baseline Internal Rotation in Abduction | 26.7 degrees | Standard Deviation 19.2 |
| Group B (Early ROM) | Change in Range of Motion (ROM)From Baseline to 24 Months | 3 months Forward Flexion | 120.0 degrees | Standard Deviation 25.4 |
| Group B (Early ROM) | Change in Range of Motion (ROM)From Baseline to 24 Months | 24 months Scaption | 150.4 degrees | Standard Deviation 13.3 |
| Group B (Early ROM) | Change in Range of Motion (ROM)From Baseline to 24 Months | 6 months Forward Flexion | 136.3 degrees | Standard Deviation 18.1 |
| Group B (Early ROM) | Change in Range of Motion (ROM)From Baseline to 24 Months | 6 weeks Internal Rotation in Abduction | 11.9 degrees | Standard Deviation 16.1 |
| Group B (Early ROM) | Change in Range of Motion (ROM)From Baseline to 24 Months | 12 months Forward Flexion | 144.8 degrees | Standard Deviation 12.4 |
| Group B (Early ROM) | Change in Range of Motion (ROM)From Baseline to 24 Months | 12 months Horizontal Adduction | 17.5 degrees | Standard Deviation 7.9 |
| Group B (Early ROM) | Change in Range of Motion (ROM)From Baseline to 24 Months | 24 months Forward Flexion | 149.9 degrees | Standard Deviation 12.4 |
| Group B (Early ROM) | Change in Range of Motion (ROM)From Baseline to 24 Months | 3 months Internal Rotation in Abduction | 23.7 degrees | Standard Deviation 16 |
| Group B (Early ROM) | Change in Range of Motion (ROM)From Baseline to 24 Months | Baseline Abduction | 116.3 degrees | Standard Deviation 40.3 |
| Group B (Early ROM) | Change in Range of Motion (ROM)From Baseline to 24 Months | 3 months Scaption | 122.2 degrees | Standard Deviation 24.4 |
| Group B (Early ROM) | Change in Range of Motion (ROM)From Baseline to 24 Months | 6 weeks Abduction | 81.4 degrees | Standard Deviation 26.3 |
| Group B (Early ROM) | Change in Range of Motion (ROM)From Baseline to 24 Months | 12 months Internal Rotation in Abduction | 33.9 degrees | Standard Deviation 9.9 |
| Group B (Early ROM) | Change in Range of Motion (ROM)From Baseline to 24 Months | 3 months Abduction | 112.1 degrees | Standard Deviation 29.1 |
| Group B (Early ROM) | Change in Range of Motion (ROM)From Baseline to 24 Months | 24 months Horizontal Adduction | 15.2 degrees | Standard Deviation 6.9 |
| Group B (Early ROM) | Change in Range of Motion (ROM)From Baseline to 24 Months | 6 months Abduction | 134.6 degrees | Standard Deviation 27.3 |
| Group B (Early ROM) | Change in Range of Motion (ROM)From Baseline to 24 Months | 24 months Internal Rotation in Abduction | 34.9 degrees | Standard Deviation 9.7 |
| Group B (Early ROM) | Change in Range of Motion (ROM)From Baseline to 24 Months | 12 months Abduction | 144.7 degrees | Standard Deviation 22.6 |
| Group B (Early ROM) | Change in Range of Motion (ROM)From Baseline to 24 Months | 12 months Scaption | 146.6 degrees | Standard Deviation 17 |
| Group B (Early ROM) | Change in Range of Motion (ROM)From Baseline to 24 Months | 24 months Abduction | 150.7 degrees | Standard Deviation 20 |
| Group B (Early ROM) | Change in Range of Motion (ROM)From Baseline to 24 Months | Baseline Horizontal Adduction | 14.4 degrees | Standard Deviation 11.1 |
| Group B (Early ROM) | Change in Range of Motion (ROM)From Baseline to 24 Months | Baseline External Rotation in Abduction | 56.9 degrees | Standard Deviation 36.2 |
| Group B (Early ROM) | Change in Range of Motion (ROM)From Baseline to 24 Months | Baseline Scaption | 125.1 degrees | Standard Deviation 31.5 |
| Group B (Early ROM) | Change in Range of Motion (ROM)From Baseline to 24 Months | 6 weeks External Rotation in Abduction | 22.6 degrees | Standard Deviation 29.1 |
| Group B (Early ROM) | Change in Range of Motion (ROM)From Baseline to 24 Months | 6 months Internal Rotation in Abduction | 32.2 degrees | Standard Deviation 12.7 |
| Group B (Early ROM) | Change in Range of Motion (ROM)From Baseline to 24 Months | 6 weeks Horizontal Adduction | 6.4 degrees | Standard Deviation 7.5 |
| Group B (Early ROM) | Change in Range of Motion (ROM)From Baseline to 24 Months | 3 months External Rotation in Abduction | 52.6 degrees | Standard Deviation 29.1 |
| Group B (Early ROM) | Change in Range of Motion (ROM)From Baseline to 24 Months | 6 months Scaption | 139.6 degrees | Standard Deviation 20.2 |
| Group B (Early ROM) | Change in Range of Motion (ROM)From Baseline to 24 Months | 6 months External Rotation in Abduction | 73.1 degrees | Standard Deviation 17.3 |
| Group B (Early ROM) | Change in Range of Motion (ROM)From Baseline to 24 Months | 3 months Horizontal Adduction | 12.5 degrees | Standard Deviation 10.4 |
| Group B (Early ROM) | Change in Range of Motion (ROM)From Baseline to 24 Months | 12 months External Rotation in Abduction | 77.9 degrees | Standard Deviation 13.4 |
Secondary
Abduction Strength Using the Power Component of the Constant Score
The Constant Score is the most widely used shoulder evaluation questionnaire in Europe and is a shoulder specific instrument. The score is a combination of an objective physical examination (65 points) and a subjective patient self evaluation (35 points). The physical examination component includes a range of motion assessment (forward elevation, lateral elevation, internal rotation, and external rotation) worth a total of 40 points (maximum of 10 points for each motion). The remaining 25 points are attributed to the strength assessment, where patients are awarded one point for each pound of pull that the patient can resist in abduction. Therefore the total possible score on the Constant score is 100 points (best possible score = 100. In this case only the power component was used therefore the best score is 25.
Time frame: Baseline, 24 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Group A (Usual Care) | Abduction Strength Using the Power Component of the Constant Score | Mean Constant Power - Baseline | 8.7 units on a scale |
| Group A (Usual Care) | Abduction Strength Using the Power Component of the Constant Score | Mean Constant Power - 24 months | 16.5 units on a scale |
| Group B (Early ROM) | Abduction Strength Using the Power Component of the Constant Score | Mean Constant Power - Baseline | 8.3 units on a scale |
| Group B (Early ROM) | Abduction Strength Using the Power Component of the Constant Score | Mean Constant Power - 24 months | 16.3 units on a scale |
Secondary
Complications
Incidence of any surgical or medical complications will be prospectively documented.
Time frame: 2 & 6 weeks, 3, 6, 12, 24 months
Population: 37 subjects (17 Early Mobilization, 20 Standard Rehabilitation) had non-re-tear complications. 5 subjects reported more than one complication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A (Usual Care) | Complications | 20 participants |
| Group B (Early ROM) | Complications | 17 participants |
Secondary
Pain Questionnaire
Shoulder pain was assessed using a visual analogue scale (VAS) where zero equals no pain and 10 is the worst possible pain at rest and with activity. Two-way repeated-measures analysis of variance (ANOVA) compared pain between groups over time.
Time frame: Baseline, 2 weeks, 6 weeks, 3, 6, 12, 24 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A (Usual Care) | Pain Questionnaire | Baseline Pain with activity | 5.2 centimeters | Standard Deviation 2.8 |
| Group A (Usual Care) | Pain Questionnaire | 6 months Pain at rest | 0.93 centimeters | Standard Deviation 1.6 |
| Group A (Usual Care) | Pain Questionnaire | 6 weeks Pain with activity | 4.0 centimeters | Standard Deviation 2.3 |
| Group A (Usual Care) | Pain Questionnaire | 6 weeks Pain at rest | 2.3 centimeters | Standard Deviation 2 |
| Group A (Usual Care) | Pain Questionnaire | 3 months Pain with activity | 2.8 centimeters | Standard Deviation 2.4 |
| Group A (Usual Care) | Pain Questionnaire | 12 months Pain at rest | 0.85 centimeters | Standard Deviation 1.7 |
| Group A (Usual Care) | Pain Questionnaire | 6 months Pain with activity | 1.8 centimeters | Standard Deviation 2.2 |
| Group A (Usual Care) | Pain Questionnaire | Baseline Pain at rest | 4.0 centimeters | Standard Deviation 2.8 |
| Group A (Usual Care) | Pain Questionnaire | 12 months Pain with activity | 1.1 centimeters | Standard Deviation 1.9 |
| Group A (Usual Care) | Pain Questionnaire | 24 months Pain at rest | 0.53 centimeters | Standard Deviation 1.3 |
| Group A (Usual Care) | Pain Questionnaire | 24 months Pain with activity | 0.74 centimeters | Standard Deviation 1.4 |
| Group A (Usual Care) | Pain Questionnaire | 3 months Pain at rest | 1.3 centimeters | Standard Deviation 1.6 |
| Group B (Early ROM) | Pain Questionnaire | 24 months Pain with activity | 0.81 centimeters | Standard Deviation 1.4 |
| Group B (Early ROM) | Pain Questionnaire | Baseline Pain at rest | 4.0 centimeters | Standard Deviation 2.8 |
| Group B (Early ROM) | Pain Questionnaire | 6 weeks Pain at rest | 2.4 centimeters | Standard Deviation 2.5 |
| Group B (Early ROM) | Pain Questionnaire | 6 months Pain at rest | 0.78 centimeters | Standard Deviation 1.3 |
| Group B (Early ROM) | Pain Questionnaire | 12 months Pain at rest | 0.49 centimeters | Standard Deviation 0.81 |
| Group B (Early ROM) | Pain Questionnaire | 24 months Pain at rest | 0.41 centimeters | Standard Deviation 0.89 |
| Group B (Early ROM) | Pain Questionnaire | Baseline Pain with activity | 5.5 centimeters | Standard Deviation 3.1 |
| Group B (Early ROM) | Pain Questionnaire | 6 weeks Pain with activity | 3.3 centimeters | Standard Deviation 2.1 |
| Group B (Early ROM) | Pain Questionnaire | 3 months Pain with activity | 2.4 centimeters | Standard Deviation 2 |
| Group B (Early ROM) | Pain Questionnaire | 6 months Pain with activity | 1.6 centimeters | Standard Deviation 2 |
| Group B (Early ROM) | Pain Questionnaire | 12 months Pain with activity | 1.1 centimeters | Standard Deviation 1.4 |
| Group B (Early ROM) | Pain Questionnaire | 3 months Pain at rest | 1.4 centimeters | Standard Deviation 1.6 |
Secondary
WORC Questionnaire
Health related quality of life was measured using the Western Ontario Rotator Cuff Index (WORC). It is a 21-item disease specific questionnaire representing five quality of life domains (physical symptoms, sports and recreation, work, lifestyle and emotions). Each response is marked on a 100mm line in a VAS format with a maximum raw score of 2100, where zero represents the best and 2100 the worst score. This score is transformed to a 0-100 format, with 100 representing full shoulder function.
Time frame: Baseline, 6, 12, 24 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Group A (Usual Care) | WORC Questionnaire | Baseline WORC Score | 40.1 units on a scale |
| Group A (Usual Care) | WORC Questionnaire | 24 months WORC Score | 90.9 units on a scale |
| Group B (Early ROM) | WORC Questionnaire | Baseline WORC Score | 40.1 units on a scale |
| Group B (Early ROM) | WORC Questionnaire | 24 months WORC Score | 89.4 units on a scale |