Early Mobilization Following Mini-Open Rotator Cuff Repair: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- University of Alberta
- Enrollment
- 189
- Locations
- 1
- Primary Endpoint
- Change in Range of Motion (ROM)From Baseline to 24 Months
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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
Arms & Interventions
Group A (Usual Care)
Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling
Intervention: Sling (Procedure)
Group B (Early ROM)
Will use the sling for comfort only. Intervention: Procedure: No sling
Intervention: No sling (Procedure)
Outcomes
Primary Outcomes
Change in Range of Motion (ROM)From Baseline to 24 Months
Time Frame: 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 Outcomes
- Pain Questionnaire(Baseline, 2 weeks, 6 weeks, 3, 6, 12, 24 months)
- Abduction Strength Using the Power Component of the Constant Score(Baseline, 24 months)
- Complications(2 & 6 weeks, 3, 6, 12, 24 months)
- WORC Questionnaire(Baseline, 6, 12, 24 months)