None listed
Conditions
Brief summary
Rotator cuff tears may affect one or more of the tendons of the four rotator cuff muscles in your shoulder, principally the supraspinatus. These tears cause significant pain and restricted movement of the arm, affecting the ability to perform daily activities, participate in sport and exercise, and the ability to work. Arthroscopic rotator cuff repair is the most popular surgical treatment for rotator cuff pathology. While surgery is considered an effective treatment, high failure rates and recurrent tears are common, especially degenerative tears, which are frequently observed in the older population. Post-operative rehabilitation is a critical part of the treatment following rotator cuff repair. Specific exercises to improve mobility and strength of the rotator cuff are commonly prescribed after repair. However, the role of post-surgical immobilisation, the amount of load that can be safely borne by the repair site throughout the early post-operative stages, and when and how to safely graduate this progressive load through rehabilitation, is currently unclear. Traditionally, repairs have been managed with passive range of motion followed by delayed active motion and, finally, strengthening exercises. However, as the incidence of repair failures grew, it has been suggested that overly aggressive rehabilitation and excessive loading at the healing repair site may play a role. Subsequently, delayed rehabilitation involving an early period of immobilization (arm in a sling) has become common practice. The rationale behind a delayed rehabilitation program stems from concerns that early repair site loading may negatively affect tendon healing, and that the repair site requires suitable time to heal without aggravation via loading. However, improvements in surgical techniques and current evidence and expert opinion suggesting that this period of immobilisation is too conservative and may potentially increase the risk of post-operative shoulder stiffness and a delayed return of shoulder muscle function, have allowed the possibility of an early, controlled post-operative treatment protocol. We hypothesise that a structured, accelerated post-operative rehabilitation program designed to safely return patients to work and sport faster, will improve patient based outcome scores and accelerate recovery of muscle function compared to a conservative regime, without risk to the repaired shoulder. This is a prospective randomised controlled trial (RCT), which seeks to investigate the benefit of an accelerated post-operative rehabilitation program after your rotator cuff repair surgery. This will be evaluated via validated questionnaires about your pain and function, clinical scores looking at your strength, mobility and function, as well as the time taken to return to work/sport, overall satisfaction and re-injury rate. This information will be of benefit to you in your return to full function, as well as other patients who require such treatment in the future.
Interventions
This is a prospective RCT investigating two different post-operative rehabilitation interventions and, therefore, all patients who are undergoing arthroscopic rotator cuff repair will be invited to participate in this trial. Participants will be invited to be part of the study after consultation with the surgeon having confirmed a full-thickness tear of the supraspinatus via clinical examination and magnetic resonance imaging (MRI), and being scheduled for surgery. At this time, the Patient Info
This is a prospective RCT investigating two different post-operative rehabilitation interventions and, therefore, all patients who are undergoing arthroscopic rotator cuff repair will be invited to participate in this trial. Participants will be invited to be part of the study after consultation with the surgeon having confirmed a full-thickness tear of the supraspinatus via clinical examination and magnetic resonance imaging (MRI), and being scheduled for surgery. At this time, the Patient Information Sheet and a verbal summary of the study and patient expectations, with particular reference to the two different rehabilitation pathways, will be presented to the patients. Patients willing to participate will then complete the Patient Consent Form and will then be randomised to one of the two rehabilitation arms of the study: conservative (CR) or accelerated (AR) rehabilitation. Patients allocated to the AR group will be required to attend an initial education session for 1 hour, 1-2 weeks post-surgery with an Accredited Exercise Physiologist (AEP) for instructions on their post-operative exercise regime, including any contraindications and an outline on progressions from passive exercises, through to active strengthening exercises. Patients will commence post-operative rehabilitation immediately following hospital discharge, receiving passive range of motion exercises from week 1 post-surgery, progressing to active-assisted ROM from week 4, strengthening from week 8, up until weeks 12-16 post surgery. Rehabilitation from weeks 1 – 4 will be initially self-managed by the patient after the initial education session. Self-managed exercises will involve undertaking prescribed exercises lasting approximately 20 to 30 minutes, 3 times per day, and will be developed and monitored via an online home-exercise software platform (Physitrack). Physitrack involves video-based demonstrations of exercise technique and dosage, and allows the therapist to monitor daily adherence and patient-reported pain, with the software allowing direct access to the therapist via email and text message in case of a problem or adverse event. At week 4, a 1 hour one-on-one session with an AEP will take place to ensure all exercises are being performed soundly, and to prescribe the active-assisted ROM exercises. From week 4 to 7, patients will again be self-managed, with the program on Physitrack updated to incorporate more active exercises. This will involve exercises for 20 to 30 minutes, 3 times per day. From the 8-week mark, patients will be required to commit to exercise rehabilitation twice per week for 6 weeks lasting approximately an hour, along with daily home exercises which will again be delivered and monitored via Physitrack. Rehabilitation commencing at this point will involve controlled strengthening exercise of the rotator cuff and scapula muscles delivered one-on-one by an experienced AEP, and cardiovascular exercise for general conditioning. Patients will be provided with a “training kit” consisting of Therabands and other simple equipment found in most homes to complete the prescribed exercises. Hard copies of the patient information sheet and exercise program will also be provided.
Sponsors
University of Western Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
35 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Male or female, between 35 and 75 years Have been diagnosed with a full-thickness tear of the supraspinatus that is deemed repairable by the surgeon. Have failed conservative treatment (physiotherapy and corticosteroid injection) prior to surgery.
Exclusion criteria
Have supraspinatus tears > 2cm, or a partial thickness tears. Present with rotator cuff tears secondary to significant trauma (fracture, dislocation etc). Have received non-surgical treatment in the rotator cuff within the three months prior to surgery, including corticosteroid injection and platelet rich plasma (PRP) injections. Present with pre-existing conditions associated with upper extremity pain, including arthritis, ongoing infection, carpal tunnel syndrome, cervical neuropathy or other nerve pathology. Are likely to have problems with follow-up (i.e. patients with no fixed address, report a plan to move out of town, or intellectually challenged patients without adequate support network). Do not read and speak English. The individual is unable or unwilling to follow the designated post-operative rehabilitation protocol.
Outcome results
None listed