Trial Review

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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] 286680 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rotator cuff tear 295023 0
Condition category
Condition code
Musculoskeletal 295283 295283 0 0
Other muscular and skeletal disorders
Surgery 295284 295284 0 0
Other surgery
Physical Medicine / Rehabilitation 295623 295623 0 0
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] 291829 0
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] 295026 0
Oxford Shoulder Score
Timepoint [1] 295026 0
Baseline, and at 6, 12, 26 and 52 weeks after intervention commencement
Primary outcome [2] 295167 0
Constant Score
Timepoint [2] 295167 0
Baseline, and at 6, 12, 26 and 52 weeks after intervention commencement
Secondary outcome [1] 314930 0
Simple Shoulder Test
Timepoint [1] 314930 0
Baseline, and at 6, 12, 26 and 52 weeks after intervention commencement
Secondary outcome [2] 314931 0
Shoulder Activity Scale
Timepoint [2] 314931 0
Baseline, and at 6, 12, 26 and 52 weeks after intervention commencement
Secondary outcome [3] 314932 0
EuroQoL 5 Dimensions Questionnaire
Timepoint [3] 314932 0
Baseline, and at 6, 12, 26 and 52 weeks after intervention commencement

Eligibility
Key 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.
Minimum age
35 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is a prospective RCT investigating two different post-operative rehabilitation interventions and, therefore, all patients who are undergoing arthroscopic rotator cuff repair with Mr Allan Wang (AW) will be invited to participate in this trial. Participants will be invited to be part of the study after consultation with the surgeon (AW), 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.

Allocation is concealed, and involves contacting the holder of the allocation schedule who is locate at an independent office “off-site”.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by a random number generator on Microsoft Excel.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample Size Calculation

A power analysis using G power software was performed to calculate the sample size required for this study. Assuming a 5% significance level and a power of 0.8, the minimal clinical important difference of 10.4 points between groups on the Constant Score and standard deviations from previous study, generated a sample size of 72 patients (36 per group).


Statistical analysis will be performed using SPSS software (SPSS, Version 11.5, SPSS Inc., USA). A series of repeated measures analysis of variance (ANOVA) will be used to investigate primary and secondary clinical outcome measures between the two rehabilitation groups at baseline, and at 6 weeks and 3, 6, and 12 months post-surgery. Where a significant interaction effect is found, post-hoc independent t-tests will be used to determine time-points at which the two groups differ. Statistical significance will be determined at p = 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3840 0
St John of God Hospital, Subiaco - Subiaco

Funding & Sponsors
Funding source category [1] 291255 0
University
Name [1] 291255 0
University of Western Australia
Country [1] 291255 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
School of Sport Science, Exercise and Health (M408)
The University of Western Australia
35 Stirling Highway
Crawley Perth
Western Australia 6009
Country
Australia
Secondary sponsor category [1] 289931 0
Hospital
Name [1] 289931 0
St John of God Hospital Subiaco Clinic
Address [1] 289931 0
302/25 McCourt Street, Subiaco WA 6008
Country [1] 289931 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 292819 0
Human Research Ethics Committee (HREC) University of Western Australia
Ethics committee address [1] 292819 0
Human Research Ethics Office (M459)
The University of Western Australia
35 Stirling Highway
Crawley Perth
Western Australia 6009
Ethics committee country [1] 292819 0
Australia
Date submitted for ethics approval [1] 292819 0
01/07/2015
Approval date [1] 292819 0
Ethics approval number [1] 292819 0
Ethics committee name [2] 292913 0
St John of God Health Care (SJGHC) Human Research Ethics Committee (HREC)
Ethics committee address [2] 292913 0
St John of God Health Care Human Research Ethics Committee
Level 3, St John of God House
177-179 Cambridge Street
Wembley WA 6014
Ethics committee country [2] 292913 0
Australia
Date submitted for ethics approval [2] 292913 0
01/07/2015
Approval date [2] 292913 0
Ethics approval number [2] 292913 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 465 465 0 0
/AnzctrAttachments/368522-Research Plan Study 3.docx
Attachments [2] 466 466 0 0
/AnzctrAttachments/368522-Participant Information Sheet Study 3.docx
Attachments [3] 499 499 0 0
/AnzctrAttachments/368522-Table 2.docx

Contacts
Principal investigator
Name 57146 0
Mr Peter Edwards
Address 57146 0
The School of Sport Science, Exercise and Health (M408), The University of Western Australia
35 Stirling Highway
Crawley, Perth, Western Australia 6009
Country 57146 0
Australia
Phone 57146 0
+61422370913
Fax 57146 0
Email 57146 0
[email protected]
Contact person for public queries
Name 57147 0
Mr Peter Edwards
Address 57147 0
The School of Sport Science, Exercise and Health (M408), The University of Western Australia
35 Stirling Highway
Crawley, Perth, Western Australia 6009
Country 57147 0
Australia
Phone 57147 0
+61422370913
Fax 57147 0
Email 57147 0
[email protected]
Contact person for scientific queries
Name 57148 0
Mr Peter Edwards
Address 57148 0
The School of Sport Science, Exercise and Health (M408), The University of Western Australia
35 Stirling Highway
Crawley, Perth, Western Australia 6009
Country 57148 0
Australia
Phone 57148 0
+61422370913
Fax 57148 0
Email 57148 0
[email protected]

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