Early Mobilization Following Arthroscopic Rotator Cuff Repair
|ClinicalTrials.gov Identifier: NCT01333527|
Recruitment Status : Active, not recruiting
First Posted : April 12, 2011
Last Update Posted : October 17, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Rotator Cuff Tear||Procedure: No Sling Procedure: Sling||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Early Mobilization Following Arthroscopic Rotator Cuff Repair: a Randomized Controlled Trial|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||April 2015|
|Estimated Study Completion Date :||December 2017|
Experimental: Group A (early ROM)
Group A (early ROM) will use the sling for comfort only
Procedure: No Sling
Early range of motion
Active Comparator: Group B (usual care)
Group B (usual care) will be immobilized in a sling for 6 weeks.
Patients will use the sling for 6 weeks, as per usual care
- WORC Questionnaire [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months ]
- Strength [ Time Frame: Baseline, 6 months, 12 months, 24 months ]
- ASES [ Time Frame: baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months ]Quality of life's questionnaires
- Adverse Events [ Time Frame: 2 weeks, 6 weeks, 3 months, 6months ]
- SF-36 [ Time Frame: baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months ]quality of life's questionnaire
- Range of Motion (ROM) [ Time Frame: baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01333527
|Glen Sather Sports Medicine clinic|
|Edmonton, Alberta, Canada, T6G 2H9|
|Principal Investigator:||David Sheps, MD,MSc,FRCSC||University of Alberta|