ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12615000644561

Ethics application status

Not yet submitted

Date submitted

26/05/2015

Date registered

22/06/2015

Date last updated

22/06/2015

Type of registration

Prospectively registered

Titles & IDs

Public title

Accelerated versus conservative rehabilitation following rotator cuff surgery to repair full-thickness tears: Clinical outcomes and recovery of muscle function.

Scientific title

Accelerated versus conservative rehabilitation following rotator cuff surgery to repair full-thickness tears: Clinical outcomes and recovery of muscle function.

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Rotator cuff tear

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Surgery

Other surgery

Physical Medicine / Rehabilitation

Physiotherapy

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Rehabilitation

Comparator / control treatment

Standard treatment will consist of conservative, post-operative rehabilitation

Patients allocated to this group will also be required to attend an initial education session for 1 hour, 1-2 weeks post-surgery with an 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. They will be required to wear an immobilisation sling for 6 weeks, and perform minimal activities of daily living. From 6 weeks post-surgery, patients will begin to undertake ROM exercises, including active-assisted exercises. Strengthening exercises will commence from 12 weeks post-surgery.

From weeks 6 to 11, patients will be self-managed, required to undertake the prescribed exercises independently at home for approximately 20 to 30 minutes, three times per day. Competency and ongoing instruction in undertaking home exercises will be determined by the treating therapist, 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 the 12-week mark, patients will be required to commit to exercise rehabilitation twice per week for 6 weeks lasting approximately one 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 Accredited Exercise Physiologist. 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.

Control group

Active

Outcomes

Primary outcome [1]

Oxford Shoulder Score

Timepoint [1]