Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000764538
Ethics application status
Approved
Date submitted
27/06/2015
Date registered
23/07/2015
Date last updated
30/06/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Preoperative group shoulder program for patients awaiting shoulder surgery
Scientific title
Effect of SPrEE (Shoulder Prehabilitation Exercise and Education Program) for patients awaiting rotator cuff surgery on function and quality of life - a randomised, controlled, clinical trial.
Secondary ID [1] 286989 0
Nil
Universal Trial Number (UTN)
U1111-1171-6130
Trial acronym
SPrEE
(Shoulder Prehabilitation Exercise and Education program)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
rotator cuff surgery 295451 0
Condition category
Condition code
Musculoskeletal 295703 295703 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PREHABILITATION- 8 week GROUP program
EDUCATION - 1 x one hour per week
EXERCISE - twice per week, one hour sessions
both administered by qualified physiotherapists in a group setting
EDUCATION- topics include shoulder anatomy, operative procedure, patient and therapist expectations, post-operative protocol and exercise technique
EXERCISE - neuromuscular control exercises for rotator cuff and scapular stabilisers (50% of allocated time of one hour) interspersed with moderate intensity (max 60% HR) general fitness exercise (25% of time) and Tai Chi (25% of time)
Attendance log will be used to monitor adherence
Intervention code [1] 292193 0
Rehabilitation
Comparator / control treatment
normal care: no active treatment
on waiting list for surgery
Control group
Active

Outcomes
Primary outcome [1] 295411 0
Shoulder Pain and Disability Index (SPADI)
Timepoint [1] 295411 0
baseline, 8 weeks post randomisation, preadmission clinic, 3, 6 and 12 month post surgery
Primary outcome [2] 295499 0
Western Ontario Rotator Cuff Index (WORC)
Timepoint [2] 295499 0
baseline, 8 weeks post randomisation, preadmission clinic, 3, 6 and 12 month post surgery
Primary outcome [3] 295500 0
Short Form 36 (SF36) to measure quality of life
Timepoint [3] 295500 0
baseline, 8 weeks post randomisation, preadmission clinic, 3, 6 and 12 month post surgery
Secondary outcome [1] 315530 0
Depression, Anxiety, Stress Scales (DASS)
(primary outcome)
Timepoint [1] 315530 0
Timepoint: baseline, 8 weeks post randomisation, preadmission clinic, 3, 6 and 12 month post surgery
Secondary outcome [2] 315708 0
Shoulder Surgery Expectation Survey
(primary outcome)
Timepoint [2] 315708 0
baseline, 3, 6 and 12 month post surgery
Secondary outcome [3] 315709 0
Visual Analogue Scale (VAS) to assess intensity of pain
Timepoint [3] 315709 0
baseline, 8 weeks post randomisation, preadmission clinic, 3, 6 and 12 month post surgery
Secondary outcome [4] 315710 0
Shoulder range of motion- forward flexion; hand-behind-back
Timepoint [4] 315710 0
baseline, 8 weeks post randomisation, preadmission clinic, 3 (as per surgeon protocol), 6 and 12 month post surgery
Secondary outcome [5] 315711 0
Shoulder strength using a dynamometer
Timepoint [5] 315711 0
baseline, 8 weeks post randomisation, preadmission clinic, 3 (as per surgeon protocol) , 6 and 12 month post surgery
Secondary outcome [6] 315712 0
Aerobic capacity- 6 minute walk test
Chester Step test
Timepoint [6] 315712 0
baseline, 8 weeks post randomisation, preadmission clinic, 3, 6 and 12 month post surgery

Eligibility
Key inclusion criteria
Aged 18 years and over

Rotator cuff pathology, calcific tendinitis, rotator cuff tear
of any size, subacromial impingement, subscapularis tendon tear; on waiting list for surgery

Willingness to give informed consent and to participate
and comply with study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with insufficient ability to understand the English language

Recent or previous fractures of the shoulder complex

Previous shoulder surgery on the affected side or both

Radiologically verified malignancy

Adhesive capsulitis

Symptoms referred from the cervical spine

Clinically verified polyarthritis, rheumatoid arthritis, fibromyalgia

Failed medical clearance to participate in exercises

Unable to agree to participate in the research protocol for 8 weeks

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)
allocation concealment procedures using sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation was performed
primary outcome measure was the Shoulder Pain And Disability Index (SPADI), whereby 18 points was considered a clinically relevant difference between the two groups, with a standard deviation of 25, alpha set on 5% and power on 80%.

Statistical Analysis Plan*
*Data double entered. Analysis by intention-to-treat and outcomes analysed in terms of change from baseline.
*Descriptive statistics (means, quartiles, standard deviations, ranges and proportions) generated for all variables included in the study.
*Standard bivariate tests (T tests and chi-square) will evaluate any potential systematic differences at baselines.
*Paired T tests to measure changes within-groups and between-groups between the preoperative and postoperative assessments.
*Changes that occur in continuous data over the entire study period analysed using a 2-way repeated measures analysis of covariance (ANCOVA) to estimate the change between the randomised groups, with baseline values of the response variables as the covariate along with group allocation.
*Demographic and other baseline characteristics will be summarised by assigned treatment group.
*Categorical variables will be summarised by frequencies and percentages. Percentages will be calculated according to the number of patients for whom data are available.
*Continuous variables will be summarised by mean and standard deviation as well as quartiles.
*Regression analysis will be undertaken to account for potential confounding variables such as age, co-morbidities, dominant arm and type of tear.



Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/07/2015
Actual
6/07/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
74
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 291546 0
Charities/Societies/Foundations
Name [1] 291546 0
The Prince of Wales Hospital Foundation
Country [1] 291546 0
Australia
Primary sponsor type
Individual
Name
Dr Judy Chen
Address
The Prince of Wales Hospital
Barker Street
Randwick
NSW 2031
Country
Australia
Secondary sponsor category [1] 290223 0
Individual
Name [1] 290223 0
Prof Bill Walsh
Address [1] 290223 0
The Prince of Wales Hospital
Barker Street
Randwick
NSW 2031
Country [1] 290223 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293088 0
South Eastern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 293088 0
Ethics committee country [1] 293088 0
Australia
Date submitted for ethics approval [1] 293088 0
Approval date [1] 293088 0
19/08/2014
Ethics approval number [1] 293088 0
HREC/14/POWH/327

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58390 0
Dr Judy Chen
Address 58390 0
The Prince of Wales Hospital
Physiotherapy Department
Barker Street
Randwick
NSW 2031
Country 58390 0
Australia
Phone 58390 0
61-2-93822850
Fax 58390 0
61-2-93822868
Email 58390 0
Judy.Chen@sesiahs.health.nsw.gov.au
Contact person for public queries
Name 58391 0
Judy Chen
Address 58391 0
The Prince of Wales Hospital
Physiotherapy Department
Barker Street
Randwick
NSW 2031
Country 58391 0
Australia
Phone 58391 0
61-2-93822850
Fax 58391 0
61-2-93822868
Email 58391 0
Judy.Chen@sesiahs.health.nsw.gov.au
Contact person for scientific queries
Name 58392 0
Judy Chen
Address 58392 0
The Prince of Wales Hospital
Physiotherapy Department
Barker Street
Randwick
NSW 2031
Country 58392 0
Australia
Phone 58392 0
61-2-93822850
Fax 58392 0
61-2-93822868
Email 58392 0
Judy.Chen@sesiahs.health.nsw.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.