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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (early ROM) | Experimental | Group A (early ROM) will use the sling for comfort only |
|
| Group B (usual care) | Active Comparator | Group B (usual care) will be immobilized in a sling for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Sling | Procedure | Early range of motion |
| |
| Sling |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months |
| 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 | baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Sheps, MD,MSc,FRCSC | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glen Sather Sports Medicine clinic | Edmonton | Alberta | T6G 2H9 | Canada |
Withdrew following randomization (n=5)
Reasons:
n=4 : Had Abduction pillow n=1: Excluded at surgery
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A (Early ROM) | Group A (early ROM) will use the sling for comfort only No Sling: Early range of motion |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A (Early ROM) | Group A (early ROM) used the sling for comfort only |
| BG001 | Group B (Usual Care) | Group B (usual care) used the sling for 6 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | percentage | Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months |
|
Over 24 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A (Early ROM) | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Persistent Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Pain in the surgical shoulder that needed further intervention |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anelise Silveira | Research Associate | 780-492-2398 | anelise.silveira@ahs.ca |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| D053825 | Suburethral Slings |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| Procedure |
Patients will use the sling for 6 weeks, as per usual care |
|
| Baseline, 6 months, 12 months, 24 months |
| 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). | baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months |
| Adverse Events | The following complications were monitored throughout study:
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). | 2 weeks, 6 weeks, 3 months, 6months |
| 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) | baseline, 6 weeks, 3, 6, 12, 24 months |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Range of Motion | 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 | Mean | Standard Deviation | degrees |
|
| 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 | Mean | Standard Deviation | percentage |
|
| Pain scale (Visual Analogue) | Shoulder pain at rest, with activity and at night were measured using a visual analogue scale of 0-10 (no pain to severe pain) | Mean | Standard Deviation | units on a scale |
|
| Strength (dynamometer microFIT3) | 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 as well as proportional to the unaffected shoulder. | Mean | Standard Deviation | pounds |
|
| Short-Form 36-Item Health Survey (SF-36) | Quality of life questionnaire that looks at physical functioning, Role-physical, bodily pain, general health, vitality, social function, role-emotional, mental health on a scale of worst to best. It is scored between 0 (no disability) and 100(very disable). | Mean | Standard Deviation | units on a scale |
|
| Surgical Characteristics | Mean | Standard Deviation | cm |
|
|
|
| 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 | Posted | Mean | Standard Deviation | degrees | baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | pounds | Baseline, 6 months, 12 months, 24 months |
|
|
|
| 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). | Posted | Mean | Standard Deviation | units on a scale | baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months |
|
|
|
| Secondary | Adverse Events | The following complications were monitored throughout study:
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). | Expected, surgical procedure related: superficial infection, frozen shoulder, biceps rupture, persistent pain, reinjury Unexpected, not treatment related: Traumatic reinjury | Posted | Count of Participants | Participants | 2 weeks, 6 weeks, 3 months, 6months |
|
|
|
| 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) | Posted | Mean | Standard Deviation | centimeters | baseline, 6 weeks, 3, 6, 12, 24 months |
|
|
|
| 0 |
| 103 |
| 0 |
| 103 |
| 10 |
| 103 |
| EG001 | 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 number of Baseline participants 103 >18 years, continuous Sex: male and female Region of enrollment | 0 | 103 | 0 | 103 | 6 | 103 |
|
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| Forward Flexion 3 months |
|
| Forward Flexion 6 months |
|
| Forward Flexion12 months |
|
| Forward Flexion 24 months |
|
| Abduction baseline |
|
| Abduction 6 weeks |
|
| Abduction 3 months |
|
| Abduction 6 months |
|
| Abduction 12 months |
|
| Abduction 24 months |
|
| External Rotation in Abduction Baseline |
|
| External Rotation in Abduction 6 weeks |
|
| External Rotation in Abduction 3 months |
|
| External Rotation in Abduction 6 months |
|
| External Rotation in Abduction 12 months |
|
| External Rotation in Abduction 24 months |
|
| Internal rotation in abduction baseline |
|
| Internal rotation in abduction 6 weeks |
|
| Internal rotation in abduction 3 months |
|
| Internal rotation in abduction 6 months |
|
| Internal rotation in abduction 12 months |
|
| Internal rotation in abduction 24 months |
|
| Horizontal adduction baseline |
|
| Horizontal adduction 6 weeks |
|
| Horizontal adduction 3 months |
|
| Horizontal adduction 6 months |
|
| Horizontal adduction 12 months |
|
| Horizontal adduction 24 months |
|
| Scaption baseline |
|
| Scaption 6 weeks |
|
| Scaption 3 months |
|
| Scaption 6 months |
|
| Scaption 12 months |
|
| Scaption 24 months |
|
| Flexion 12 months |
|
| Flexion 24 months |
|
| Abduction baseline |
|
| Abduction 6 months |
|
| Abduction 12 months |
|
| Abduction 24 months |
|
| External rotation in abduction baseline |
|
| External rotation in abduction 6 months |
|
| External rotation in abduction 12 months |
|
| External rotation in abduction 24 months |
|
| Internal rotation in abduction baseline |
|
| Internal rotation in abduction 6 months |
|
| Internal rotation in abduction 12 months |
|
| Internal rotation in abduction 24 months |
|
| Horizontal Adduction baseline |
|
| Horizontal Adduction 6 months |
|
| Horizontal Adduction 12 months |
|
| Horizontal Adduction 24 months |
|
| Scaption baseline |
|
| Scaption 6 months |
|
| Scaption 12 months |
|
| Scaption 24 months |
|
| physical functioning 3 months |
|
| physical functioning 6 months |
|
| physical functioning 12 months |
|
| physical functioning 24 months |
|
| role physical baseline |
|
| role physical 6 weeks |
|
| role physical 3 months |
|
| role physical 6 months |
|
| role physical 12 months |
|
| role physical 24 months |
|
| bodily pain baseline |
|
| bodily pain 6 weeks |
|
| bodily pain 3 months |
|
| bodily pain 6 months |
|
| bodily pain 12 months |
|
| bodily pain 24 months |
|
| General Health baseline |
|
| General Health 6 weeks |
|
| General Health 3 months |
|
| General Health 6 months |
|
| General Health 12 months |
|
| General Health 24 months |
|
| Vitality baseline |
|
| Vitality 6 weeks |
|
| Vitality 3 months |
|
| Vitality 6 months |
|
| Vitality 12 months |
|
| Vitality 24 months |
|
| Social function baseline |
|
| Social function 6 weeks |
|
| Social function 3 months |
|
| Social function 6 months |
|
| Social function 12 months |
|
| Social function 24 months |
|
| role emotional baseline |
|
| role emotional 6 weeks |
|
| role emotional 3 months |
|
| role emotional 6 months |
|
| role emotional 12 months |
|
| role emotional 24 months |
|
| Mental health baseline |
|
| Mental health 6 weeks |
|
| Mental health 3 months |
|
| Mental health 6 months |
|
| Mental health 12 months |
|
| Mental health 24 months |
|
| Biceps Rupture |
|
| Persistent Pain |
|
| Re-injury not requiring surgery |
|
| Urinary |
|
| Gastrointestinal |
|
| Cardiac |
|
| Pulmonary |
|
| Metabolic |
|
| Nerve Injury |
|
| Deep infection |
|
| Dislocation |
|
| Hematoma |
|
| Dermatitis |
|
| Reflex Sympathetic Dystrophy (RSD) |
|
| Traumatic Re-injury |
|
| Pain at rest 3 months |
|
| Pain at rest 6 months |
|
| Pain at rest 12 months |
|
| Pain at rest 24 months |
|
| Pain with activity - baseline |
|
| Pain with activity 6 weeks |
|
| Pain with activity 3 months |
|
| Pain with activity 6 months |
|
| Pain with activity 12 months |
|
| Pain with activity 24 months |
|
| Pain at night - baseline |
|
| Pain at night 6 weeks |
|
| Pain at night 3 months |
|
| Pain at night 6 months |
|
| Pain at night 12 months |
|
| Pain at night 24 months |
|