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Trial registered on ANZCTR


Registration number
ACTRN12613000859785
Ethics application status
Approved
Date submitted
24/07/2013
Date registered
5/08/2013
Date last updated
5/08/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effects of a therapeutic exercise programme plus or minus manual handling and tape for painful restriction of shoulder movement and function
Scientific title
The effects of a therapeutic exercise programme plus or minus manual therapy and tape on shoulder range of movement, pain and function in people with shoulder pain that limits ability to raise arm overhead
Secondary ID [1] 282856 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder pain 289662 0
Condition category
Condition code
Musculoskeletal 289984 289984 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 290074 290074 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Therapeutic exercise plus manual therapy with movement and tape and a home exercise programme
Attendance for 4 treatment sessions each approximately 45 minutes once per week for 4 weeks. The manual therapy technique is a Mulligan's Mobilisation with Movement(MWM) to the glenohumeral joint 10 repetitions x 3 sets.
Exercises are to be performed twice daily.They are individually prescribed including numbers of repetitions and resistance ( free weights or theraband) for each exercise They include progressive exercises for the scapular stabilisers - lower traps and serratus anterior and progressive strengthening for the rotator cuff muscles. Compliance is monitored by asking the patient to rate compliance on a percentage basis - total compliance, 90-75%, 74-50%, 49-25% and < 25% between each of the 4 weekly treatment sessions.
Two layers of tape are applied (Fixomull and rigid tape) immediately following the Mobilisation with Movement (MWM) application at each of the 4 treatment sessions to clean dry skin. This is applied by the same treating physiotherapist from the anterior humeral head over the GHJ diagonally across the scapula to the level of T7. The patient is asked to leave the tape on for 24 hours unless there is any adverse reaction to the tape such as burning or itching. In this case they are asked to remove the tape immediately and note the length of time the tape was in place.
Intervention code [1] 287547 0
Treatment: Other
Comparator / control treatment
Therapeutic exercise plus a home exercise programme individually prescribed as per the intervention group Attendance is also for 30 -45 minutes for each of 4 weeks.

The same treating physiotherapist prescribes an individualized programme targeting the scapular stabilizers and rotator cuff muscles. Compliance is monitored as per the Mobilisation with Movement (MWM)and tape group.

Control group
Active

Outcomes
Primary outcome [1] 290036 0
Goniometric measure of AROM to pain onset in scaption
Timepoint [1] 290036 0
Baseline, 4 weeks, 8 weeks
Primary outcome [2] 290092 0
Pain measures using PPT and VAS 0-10 cm
Timepoint [2] 290092 0
baseline, 4 weeks, 8 weeks post interventions
Primary outcome [3] 290093 0
heat and cold sensitivity measures using quantitative sensory testing - onset of the feeling of heat and cold turning to one of discomfort plus heat and cold
Timepoint [3] 290093 0
baseline, 4 weeks, 8 weeks
Secondary outcome [1] 303818 0
Patient specific outcome 1-3
Any activitythat the patient is reporting having problem with because of the shoulder pain.
e.g. lifting heavy objects down from overhead , taking shirt off overhead, sustaining forward arm position
The patient is asked to rate their pain level when performing their specific activity that is causing pain on a VAS scale 0 - 10 cm
Timepoint [1] 303818 0
baseline, 4 weeks, 8 weeks post initial intervention,
Secondary outcome [2] 303982 0
Shoulder pain and disability assessed using the SPADI
Timepoint [2] 303982 0
baseline, 4 weeks, 8 weeks

Eligibility
Key inclusion criteria
Shoulder pain for a minimum 4 weeks duration which is provoked or increased by arm elevation and participants aged between18 and 65 years.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Recent shoulder dislocation, any recent fractures around the shoulder, systemic illnesses such as rheumatoid arthritis, acute phase of adhesive capsulitis, shoulder pain that is deemed to be originating from the neck or if there is a neurological impairment, osteoporosis, haemophilia and/or malignancies, any treatment of shoulder pain by a health care practitioner within the last six weeks and /or a corticosteroid injection to the shoulder joint in the last six months.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using coin toss for allocation to the envelope.
Group allocation (MT , tape and TE and HEP vs TE and HEP) placed in envelopes, those envelopes were sealed and then mixed and numbered for participants
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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/11/2012
Actual
27/11/2012
Date of last participant enrolment
Anticipated
30/11/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 7210 0
4011 - Hendra
Recruitment postcode(s) [2] 7211 0
4012 - Wavell Heights
Recruitment postcode(s) [3] 7212 0
4014 - Nudgee
Recruitment postcode(s) [4] 7213 0
4013 - Northgate

Funding & Sponsors
Funding source category [1] 287684 0
University
Name [1] 287684 0
Griffith University
Country [1] 287684 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Parklands Drive
Southport QLD 4215
Country
Australia
Secondary sponsor category [1] 286416 0
None
Name [1] 286416 0
Address [1] 286416 0
Country [1] 286416 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289643 0
Griffith University Office of Human Research Ethics
Ethics committee address [1] 289643 0
Griffith Unviersity
Parklands Drive
Southport QLD 4215
Ethics committee country [1] 289643 0
Australia
Date submitted for ethics approval [1] 289643 0
Approval date [1] 289643 0
04/09/2012
Ethics approval number [1] 289643 0
PES/34/12/HREC

Summary
Brief summary
The aim of this research is to investigate the optimal conservative approach to the treatment of patients with shoulder pain. There is evidence to demonstrate that exercise alone is better than a wait and see approach and also that one treatment session of a specific manual therapy and tape improves movement in people with shoulder pain.
It is hoped that information gathered from this project will help to contribute to knowledge of an optimal conservative treatment approach to shoulder pain that limits a person’s ability to carry out many activities of daily living and to participate in work and sport.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41530 0
Ms Pamela Teys
Address 41530 0
School of Physiotherapy
The Australian Catholic University
1100 Nudgee Road
Banyo Qld 4014
Country 41530 0
Australia
Phone 41530 0
+617 36237689
Fax 41530 0
+617 36237650
Email 41530 0
[email protected]
Contact person for public queries
Name 41531 0
Ms Pamela Teys
Address 41531 0
School of Physiotherapy
The Australian Catholic University
1100 Nudgee Road
Banyo Qld 4014
Country 41531 0
Australia
Phone 41531 0
+61736237689
Fax 41531 0
+61736237650
Email 41531 0
[email protected]
Contact person for scientific queries
Name 41532 0
Dr Leanne Bisset
Address 41532 0
Scholl of Rehabilitation Sciences
Griffith University
Parklands Drive
Southport QLD 4215
Country 41532 0
Australia
Phone 41532 0
+61-7-55527717
Fax 41532 0
Email 41532 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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