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Trial registered on ANZCTR


Registration number
ACTRN12617001405303
Ethics application status
Approved
Date submitted
19/09/2017
Date registered
4/10/2017
Date last updated
6/05/2019
Date data sharing statement initially provided
6/05/2019
Date results information initially provided
6/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Tailored versus standard strengthening rehabilitation for patients with shoulder pain: a feasibility trial
Scientific title
The effectiveness of a tailored rehabilitation versus standard strengthening programme for patients with shoulder pain: a feasibility randomized controlled trial (the Otago MASTER trial)
Secondary ID [1] 292619 0
None
Universal Trial Number (UTN)
U1111-1200-4591
Trial acronym
The Otago MASTER trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder subacromial pain 304307 0
Condition category
Condition code
Musculoskeletal 303662 303662 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 304153 304153 0 0
Physiotherapy
Physical Medicine / Rehabilitation 304154 304154 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients allocated to this group will receive 16 individual, face-to-face sessions, each lasting for 60 min, twice per week, over an 8-week period. The intervention will be delivered by an experienced musculoskeletal physiotherapists.

The intervention consists of sustained mobilization followed by exercises focusing on restoring normal movement pattern and the dynamic stability of the scapulothoracic and glenohumeral joints. The intervention will involve manual therapy techniques focusing on restoring cervical or thoracic spinal movement, and shoulder and scapular movement to reduce pain, and motor control and progressive resistance training of impaired muscles.

Manual therapy techniques and motor control and progressive resistance training will be tailored based on physical impairments presented by the patient, and identified through a thorough physical examination. Progression of dynamic exercises (i.e. concentric-eccentric contractions) will be performed by increasing the number of sets from two to three.

Participants will perform a total of 8 strengthening exercises (with two sets of ten repetitions each) and may receive up to three manual therapy techniques per session of treatment.

Participants will be asked to perform two types of home-based exercise, with 2-3 sets of 10 repetitions each. The exercises will be tailored to participants' physical impairments.

Participants will be asked to perform home-based exercises during the days that they do not attend the physiotherapy session.
Intervention code [1] 298911 0
Rehabilitation
Comparator / control treatment
Group 2 – Standardized exercise training:

Patients allocated to this group will receive 16 individual, face-to-face sessions, each lasting for 60 min, twice per week, over an 8-week period. The intervention will be delivered by an experienced musculoskeletal physiotherapists.

The intervention focuses on restoring muscle strength and flexibility and has been shown to be more effective than ‘no intervention’ or control for reducing pain and disability. Participants will perform a total of 8 strengthening exercises (with two sets of ten repetitions each) and three stretching exercises per session of treatment. Progression of progressive resistance training for all scapular and shoulder muscles and stretching dynamic exercises (i.e. concentric-eccentric contractions) will be performed by increasing the number of sets from two to three. In this group, participants will not receive any form of manual therapy technique.

The key difference between Groups 1 and 2 is that participants in Group 2 will receive a standardized strengthening and flexibility programme that is not tailored to individual physical impairments. Participants in Group 2 will complete the same strengthening programme (with minor variations regarding load progression).

Participants will be asked to perform two types of home-based exercise, with 2-3 sets of 10 repetitions each. The exercises will be the same for all participants, and not based on specific physical impairments.

Participants will be asked to perform home-based exercises during the days that they do not attend the physiotherapy session.
Control group
Active

Outcomes
Primary outcome [1] 303023 0
Recruitment rate
Timepoint [1] 303023 0
Monthly for eighteen months.
Primary outcome [2] 303024 0
Proportion of participants enrolled from the total number screened, expressed as the ratio “number of enrolled participants/total number of screened participants” with reasons for exclusion.
Timepoint [2] 303024 0
Monthly for eighteen months.
Primary outcome [3] 303025 0
Adherence to the rehabilitation programme, measured as number of sessions attended, and expressed as a percentage of the total number of sessions
Timepoint [3] 303025 0
Weekly for 8 weeks.
Secondary outcome [1] 337714 0
Drop-out rates, measured as the number of participants who dropped-out, and expressed as a percentage of the total number of participants enrolled in the study
Timepoint [1] 337714 0
Weekly for 12 months.
Secondary outcome [2] 337715 0
Pain level as measured by a numeric pain scale.
Timepoint [2] 337715 0
Baseline, and Weeks 4, 8, and 12
Secondary outcome [3] 337716 0
Shoulder-related disability assessed using the ‘patient specific functional scale’ (PSFS)
Timepoint [3] 337716 0
Baseline, and Weeks 4, 8, and 12
Secondary outcome [4] 337717 0
Health outcomes will be expressed as quality-adjusted life year (QALY) using the Short-Form 12 (SF-12v2).
Timepoint [4] 337717 0
Baseline, and Week 12
Secondary outcome [5] 338378 0
Shoulder Pain and Disability Index (SPADI)
Timepoint [5] 338378 0
Baseline, Weeks 4, 8, and 12
Secondary outcome [6] 338995 0
Adverse reaction (as reported by participants)
Timepoint [6] 338995 0
Weekly for 8 weeks
Secondary outcome [7] 370054 0
Pain self-efficacy questionnaire
Timepoint [7] 370054 0
Baseline, Weeks 4, 8, and 12

Eligibility
Key inclusion criteria
Inclusion and exclusion criteria
Patients from 18 years to 65 years old, with mechanical shoulder pain will be recruited to participate in the study. Participants will be screened as per the British Elbow and Shoulder Society (BESS) guidelines. Participants will be included if they present one positive finding on the following tests: (1) Painful arc movement during shoulder flexion or abduction; or (2) pain on resisted lateral rotation or abduction or Jobe’s test.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
We will exclude participants with the history of shoulder dislocation, shoulder subluxation, shoulder surgery and cervical surgery within the last 6 months, participants with symptoms of inflammation or systematic disease, signs of paraesthesia in the upper extremities, hemiplegic shoulder pain, frozen shoulder, or positive clinical signs of full thickness rotator cuff tear will be excluded.

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)
The randomisation schedule will be concealed in numbered sealed, opaque envelopes. A research administrator will provide the envelope to the clinician delivering the interventions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be computer-generated by a research administrator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

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
All statistical analyses will be performed using R software. Descriptive statistics will be used to analyse: (1) recruitment rates; (2) adherence to the rehabilitation programme; (3) proportion of participants enrolled from the total number screened; (4) drop-out rates; (5) adverse reactions.

To obtain estimates of intervention effects, we will compare changes in pain and shoulder-related disability scores between the two intervention groups (i.e. tailored and standardized rehabilitation) a repeated mixed-model analysis of variance (ANOVA) will be used. Group intervention (tailored and standardized rehabilitation) will be considered as between-subject factor, and ‘time-point’ (baseline, 4th, 8th week and 12th week) will be considered as within-subject factor. Baseline measurements will be considered as covariates. We will conduct an independent mixed-model ANOVA for each outcome measure (i.e. pain levels and shoulder-related disability). Alpha will be set at 0.05, and power at 80% for all statistical analysis. Since this is a feasibility study, we will not adjust alpha for multiple comparisons. This will decrease the chance of Type II error, increasing the chance of identifying potentially important differences between groups. This statistical approach is considered appropriate for feasibility or exploratory studies.

The Bayesian method will be used to interpret findings from the feasibility trial, and determine whether or not it is worthwhile conducting the full trial. It is recommended that other confidence interval (CI) ranges should be used (e.g. 85% or 75%CI in addition to the mean difference and the respective 95%CI) when assessing differences between groups from feasibility trials.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9137 0
New Zealand
State/province [1] 9137 0
Otago

Funding & Sponsors
Funding source category [1] 297248 0
Government body
Name [1] 297248 0
Health Research Council
Address [1] 297248 0
Level 3 - ProCARE Building, Grafton Mews, at 110 Stanley Street, Auckland Postcode: 1010 PO Box 5541, Wellesley Street, Auckland 1141
Country [1] 297248 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
325 Great King Street,
Postcode: 9054
PO Box 56
Dunedin
Country
New Zealand
Secondary sponsor category [1] 296219 0
None
Name [1] 296219 0
Address [1] 296219 0
Country [1] 296219 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298368 0
University of Otago Ethics Committee
Ethics committee address [1] 298368 0
University of Otago Council PO Box 56 Dunedin 9054 New Zealand
Ethics committee country [1] 298368 0
New Zealand
Date submitted for ethics approval [1] 298368 0
20/06/2017
Approval date [1] 298368 0
20/07/2017
Ethics approval number [1] 298368 0

Summary
Brief summary
This is a two-arm, assessor-blinded, patient-blinded, randomized controlled feasibility trial. Twenty-four patients with shoulder subacromial pain will be recruited randomly allocated into the standardized or tailored rehabilitation group. Both groups will receive a total of 16 sessions over 8 weeks. Follow-up will occur at 4, 8 and 12 weeks after baseline.

In this feasibility trial we aim to assess: (1) patients recruitment rate; how any percent of patients agree to participate, patients adherence to the rehabilitation program, and drop-out rates; (2) to obtain the estimates of adverse reactions to treatment; (3) to measure the estimates of intervention effects in order to inform the sample size of the fully-powered RCT.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76846 0
Dr Daniel Cury Ribeiro
Address 76846 0
School of Physiotherapy - University of Otago 325 Great King Street, Postcode: 9054, PO Box 56, Dunedin
Country 76846 0
New Zealand
Phone 76846 0
+64 3 479 7455
Fax 76846 0
Email 76846 0
daniel.ribeiro@otago.ac.nz
Contact person for public queries
Name 76847 0
Dr Daniel Cury Ribeiro
Address 76847 0
School of Physiotherapy - University of Otago 325 Great King Street, Postcode: 9054, PO Box 56, Dunedin
Country 76847 0
New Zealand
Phone 76847 0
+64 3 479 7455
Fax 76847 0
Email 76847 0
daniel.ribeiro@otago.ac.nz
Contact person for scientific queries
Name 76848 0
Dr Daniel Cury Ribeiro
Address 76848 0
School of Physiotherapy - University of Otago 325 Great King Street, Postcode: 9054, PO Box 56, Dunedin
Country 76848 0
New Zealand
Phone 76848 0
+64 479 7455
Fax 76848 0
Email 76848 0
daniel.ribeiro@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary