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Trial registered on ANZCTR


Registration number
ACTRN12615000704594
Ethics application status
Approved
Date submitted
15/06/2015
Date registered
7/07/2015
Date last updated
20/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise intervention for subacromial impingement syndrome. A randomised controlled trial of two rehabilitation protocols.
Scientific title
Is an intervention consisting of up to 3 pain free exercises equivalent to a standard evidence based protocol in regards to pain, function and compliance for patients aged between 30 and 65 with intermittent unilateral shoulder pain and positive impingement tests.
Secondary ID [1] 286852 0
Nil
Universal Trial Number (UTN)
U1111-1170-8845
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder impingement syndrome
295246 0
Subacromial pain syndrome 295389 0
Condition category
Condition code
Musculoskeletal 295491 295491 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 295492 295492 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will be given individualised exercises according to a protocol that: excludes exercise in the presence of pain and excludes exercises that reduce the subacromial space.
There are 2 standard exercises- Elastic resisted adduction and extension and an optional 3rd exercise (internal rotation against elastic resistance).
Participants will attend a maximum of 8 physiotherapy session over 12 weeks. No manual therapy is performed at physiotherapy sessions.
The initial physiotherapy session will be for 1 hour with subsequent visits being 30 minutes.
Exercises are performed as a home exercise programme using elastic supplied to the participant. Subjects are asked to aim to complete the exercises every 2 hrs. Exercises are started at repetitions determined by the physiotherapist with an aim of 10-15 repetitions per occasion per exercise.
Physiotherapists are provided with the following directions regarding progression:
* Do not progress elastic resistance
* Add internal rotation if not prescribed at start of programme
* Can increase repetitions up to 20-25 per exercise per occasion
* Can increase ROM through which exercises are performed

Participants are encouraged to continue exercises after 12 weeks according to previous instructions regarding maintenance exercise.
A self reported exercise diary will be used to monitor and record compliance.
Intervention code [1] 292020 0
Rehabilitation
Intervention code [2] 292145 0
Treatment: Other
Comparator / control treatment
Subjects will be given individualised treatment according to a recommended protocol from the literature (Holmgren et al 2012). Specifically, the protocol advocates: exercises performed within tolerable levels of pain/ discomfort that include exercises that reduce the subacromial space.
Exercises include resisted internal and external rotation, abduction, range of motion exercises and manual therapy.
Participants will attend a maximum of 8 physiotherapy session over 12 weeks. The initial physiotherapy session will be for 1 hour with subsequent visits being 30 minutes. Exercises are performed as a home exercise programme.
Manual therapy can be performed at the physiotherapist's discretion, particularly aimed at stretching the posterior glenohumeral capsule and pectoralis minor muscle.
Exercises are not allowed to provoke more than a 5/10 pain and are:
* Repeated 15 times in 3 sets twice daily for 8 weeks.
* Perform posterior shoulder stretch for 30-60 seconds and repeat 3 times twice daily.
* From week 8 to week 12, repeat exercises once a day.
Progress by:
* The exercises are individually adjusted and progressed with increased external load using weights and elastic rubber bands at physiotherapist visits once every fortnight during the whole rehabilitation period.
* Don’t increase number of exercises per day.

Following completion of the specific exercise programme (after 12 weeks), participants should maintain the daily home exercises for another 2 months.

A self reported exercise diary will be used to monitor and record compliance.
Control group
Active

Outcomes
Primary outcome [1] 295224 0
Patient Specific Functional Scale (PSFS), limited to 3 items
Timepoint [1] 295224 0
Recruitment
6 weeks
12 weeks
6 months
Primary outcome [2] 295225 0
Pain levels using the Visual Analague Scale (VAS)
Timepoint [2] 295225 0
Recruitment
6 weeks
12 weeks
6 months
Primary outcome [3] 295226 0
Compliance measured by daily exercise diary and dropouts
Timepoint [3] 295226 0
6 weeks
12 weeks
6 months
Secondary outcome [1] 315110 0
Shoulder range of motion of abduction and flexion
Timepoint [1] 315110 0
Recruitment
6 weeks
12 weeks
6 months
Secondary outcome [2] 315111 0
13 point global rating of change
Timepoint [2] 315111 0
6 weeks
12 weeks
6 months
Secondary outcome [3] 315112 0
Shoulder Pain and Disability Index (SPADI)
Timepoint [3] 315112 0
Recruitment
6 weeks
12 weeks
6 months
Secondary outcome [4] 315113 0
Pain self efficacy questionnaire
Timepoint [4] 315113 0
Recruitment
6 weeks
12 weeks
6 months
Secondary outcome [5] 315114 0
Patient expectations using the:
Patient Shoulder Outcome Expectancies (PSOE)
and
Patient Shoulder Expectancy Fulfillment (PSEF)
Timepoint [5] 315114 0
Recruitment
6 weeks
12 weeks
6 months

Eligibility
Key inclusion criteria
Referred for physiotherapy treatment and
a) Aged between 30-65
b) Pain is intermittent
c) Pain behaves mechanically
d) Positive for impingement signs; Hawkins-Kennedy Test, Neers Test, Painful arc and Allingham's Test
Minimum age
30 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Suspected or diagnosed pathologies arising from vertebral column structures.
b) Diagnoses of neoplastic disorders.
c) Pain potentially from inflammatory (including adhesive capsulitis) or neurogenic origin.
d) Clinical features (Murrell and Walton 2001) or radiological evidence of rotator cuff tear.
e)Shoulder trauma, or cervical or upper thoracic spine injury in the previous 12 weeks.
f) Previous shoulder dislocation.
g) Previous CVA.
h) Severe pain that prevents exercises from being undertaken.
i) Bilateral shoulder pain (since comparison with the contralateral side is required for certain outcome measurements).
j) Inability to provide informed consent.
k) Patients who decline to comply with an exercise program.
l) Patients who do not speak English, Vietnamese or Arabic.

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 receptionist will inform patients with a referral for physiotherapy for shoulder pain, who present to the Physiotherapy Outpatient Department at Fairfield Hospital, about the study. She will arrange a routine appointment for assessment/triage and provide an Information Sheet. When the patient subsequently presents for assessment, the receptionist will ask the patient whether they are willing to participate. Volunteers will be provided a Consent Form. This process will obviate the need for the assessing physiotherapist to recruit subjects. Those patients interested in participating will be consented by another physiotherapist, who is not involved in the provision of treatment.
Patients who decline to participate will be assessed and treated according to the usual procedures for the Physiotherapy Department and treatment will not be withheld in any way.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Prior to the study, a researcher not involved in data collection or treatment will generate a randomisation sequence. Labelled pieces of paper with the intervention arm will be placed in sealed opaque envelopes according to the random sequence. The envelopes will labelled with a subject number between 1 and 20 written on the front. Subjects will be allocated consecutively according to their entry number into the study. The envelopes will be kept at University of Western Sydney by a researcher not involved in measurement or treatment of subjects, and will be delivered to the hospital as each block sequence is completed. The Receptionist shall keep the envelopes in a secure location.
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
A blinded assessor, not been involved in the treatment of subjects and unaware of the subject’s allocation, will perform data analyses. Planned Contrasts within a Repeated measures ANOVA will be employed to describe within- and between-group differences for each continuous outcome measure. Exercise compliance and medication use will be compared using Chi Square analyses, since data will be categorical. Data will be analysed according to the intention-to-treat principle to account for drop-outs (Peat, 2001).
Regarding target sample size: a figure of 80 per treatment arm is indicative. Following recruitment of the first 20 participants, an independent assessor shall determine mean and standard deviation data for analyses to determine the number of patients required to appropriately power the study for a level of 0.8 at an alpha level of 0.05, allowing for 20% drop outs. Assumptions include minimal clinically important differences of 15/100 for pain intensity and 20% for the Patient Specific Functional Scale.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/07/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3903 0
Fairfield Hospital - Prairiewood
Recruitment postcode(s) [1] 9807 0
2176 - Prairiewood

Funding & Sponsors
Funding source category [1] 291441 0
Self funded/Unfunded
Name [1] 291441 0
Country [1] 291441 0
Primary sponsor type
Hospital
Name
Fairfield Hospital
Address
Cnr of Polding St and Prairievale Rd, Prairewood, NSW, 2176.
Country
Australia
Secondary sponsor category [1] 290116 0
None
Name [1] 290116 0
Address [1] 290116 0
Country [1] 290116 0
Other collaborator category [1] 278494 0
University
Name [1] 278494 0
University of Western Sydney
Address [1] 278494 0
Physiotherapy
School of Science and Health
University of Western Sydney
Narellan Road
Campbelltown NSW 2560
Australia

Post:
Physiotherapy
School of Science and Health
University of Western Sydney
Locked Bag 1797
Penrith NSW 2751
Australia
Country [1] 278494 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292993 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 292993 0
Ethics committee country [1] 292993 0
Australia
Date submitted for ethics approval [1] 292993 0
Approval date [1] 292993 0
09/01/2015
Ethics approval number [1] 292993 0
HREC/14/LPOOL/195

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 496 496 0 0
/AnzctrAttachments/368685-ApprovalJan15.pdf
Attachments [2] 497 497 0 0
/AnzctrAttachments/368685-ProtocolApril16_14.pdf

Contacts
Principal investigator
Name 57798 0
Dr Robert Boland
Address 57798 0
Physiotherapy Department
Fairfield Health Service (FHS)
PO BOX 5
Fairfield, NSW 1851
Country 57798 0
Australia
Phone 57798 0
+612 9616 8324
Fax 57798 0
+612 9616 8537
Email 57798 0
[email protected]
Contact person for public queries
Name 57799 0
Toni Andary
Address 57799 0
Physiotherapy Department
FHS
PO BOX 5
Fairfield, NSW 1851
Country 57799 0
Australia
Phone 57799 0
+612 9616 8324
Fax 57799 0
+612 9616 8537
Email 57799 0
[email protected]
Contact person for scientific queries
Name 57800 0
Robert Boland
Address 57800 0
Physiotherapy Department
FHS
PO BOX 5
Fairfield, NSW 1851
Country 57800 0
Australia
Phone 57800 0
+612 9616 8324
Fax 57800 0
+612 9616 8537
Email 57800 0
[email protected]

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