Early Mobilization Following Arthroscopic Rotator Cuff Repair

Study Overview
=================
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.

Official Title
-----------------
Early Mobilization Following Arthroscopic Rotator Cuff Repair: a Randomized Controlled Trial

Conditions
-----------------
Rotator Cuff Tear

Intervention / Treatment
-----------------
* Procedure: No Sling
* Procedure: Sling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is over 18 years of age Patient has attempted non-operative treatment (i.e. physical therapy consisting of progressive ROM, strengthening, and postural exercises) Patient has a full-thickness tear of the supraspinatus and/or infraspinatus, as confirmed by appropriate diagnostic imaging (MRI, Arthrogram, Ultrasound) Exclusion Criteria: Patient has a full-thickness tear of the subscapularis and/or teres minor Patient has undergone previous RC surgery to the affected shoulder Patient has major joint trauma, infection, or avascular necrosis Patient has chronic dislocation, inflammation, or degenerative glenohumeral arthropathy Patient has evidence of significant cuff arthropathy (superior glenohumeral translation and/or acromial erosion, as diagnosed by diagnostic imaging) 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 Patient has a major medical illness where life expectancy is less than 2 years Patient does not speak/read/understand English Patient has no fixed address or means of contact Surgeon or patient has decided to cancel surgery Surgeon concludes that an arthroscopic repair is not appropriate at time of surgery (based on RC tear characteristics or concomitant shoulder pathology) Patient unwilling to complete necessary follow-ups

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A (early ROM)<br>Group A (early ROM) will use the sling for comfort only | Procedure: No Sling<br>* Early range of motion<br>|
| Active Comparator: Group B (usual care)<br>Group B (usual care) will be immobilized in a sling for 6 weeks. | Procedure: Sling<br>* Patients will use the sling for 6 weeks, as per usual care<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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: 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). | 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 |