Early Mobilization Following Arthroscopic Rotator Cuff Repair

Not Applicable

Completed

Conditions: Rotator Cuff Tear

Interventions: Procedure: No Sling
Procedure: Sling

Registration Number: NCT01333527

Lead Sponsor: University of Alberta

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 211

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (early ROM)	No Sling	Group A (early ROM) will use the sling for comfort only
Group B (usual care)	Sling	Group B (usual care) will be immobilized in a sling for 6 weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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)
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).