Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000404426
Ethics application status
Not yet submitted
Date submitted
31/07/2007
Date registered
6/08/2007
Date last updated
6/08/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does a Stretching Regime Decrease Posterior Shoulder Tightness in People with Subacromial Impingement Syndrome?
Scientific title
A study to evaluate the effectiveness of Posterior Capsule Stretches on increasing range, decreasing pain and increasing function in people with Subacromial Impingement Syndrome (SAIS)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subacromial Impingement Syndrome 2201 0
Condition category
Condition code
Musculoskeletal 2296 2296 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Preliminary Study: People randomly assigned a sequence of treatment modalities (Posterior Capsule stretch, Placebo Stretch (External Rotation) and no stretch) over three seperate days. 24 hours between each treatment session.
Main Study:
Intervention: Posterior Capsule Stretch- Person is in Side-ly on the affected side and humerus at 90 degrees abduction, elbow at 90 degrees flexion. The person internally rotates the arm till a strong but comfortable pull is felt in the posterior shoulder. The person undertakes the stretch for 60 seconds and repeats three times, this is done three times a day for 6 weeks. They also undertake a 'standardised' Physiotherapy exercise program.

Both groups recieve Standardised Physiotherapy for 6 weeks and then can have ongoing treatment as per Physiotherapist discretion.
Intervention code [1] 1916 0
Rehabilitation
Comparator / control treatment
Control: The person undertakes a 'standardised' Physiotherapy Exercises program with no posterior caspule stretches.
Control group
Active

Outcomes
Primary outcome [1] 3186 0
Change in Range: Crossed adduction measure.
Timepoint [1] 3186 0
This will be measured at baseline, after each of the three interventions in the preliminary study and at 6 weeks, 3 and 6 months for the main study.
Secondary outcome [1] 5312 0
Change in pain: Visual Analogue Scale (VAS)
Timepoint [1] 5312 0
At baseline, 6 weeks, 3 and 6 months for the main study.
Secondary outcome [2] 5313 0
Change in Pain sensitivity: Pressure Pain threshold.
Timepoint [2] 5313 0
At baseline, 6 weeks, 3 and 6 months for the main study.
Secondary outcome [3] 5314 0
Change in Function: SF-36 Short Form
Timepoint [3] 5314 0
At baseline, 6 weeks, 3 and 6 months for the main study.

Eligibility
Key inclusion criteria
Patients with a clinical diagnosis of unilateral SAIS and at least four weeks duration of symptoms. The diagnosis will be based on the patients' history and a clinical examination, which will include the reproduction of pain with shoulder internal rotation at ninety degrees of flexion (Hawkins Test) and posterior shoulder tightness as indicated by a loss of more than 2 cm on crossed adduction shoulder measures when compared to the unaffected side (Tyler et al., 1999). All genders included.
Minimum age
18 Years
Maximum age
66 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from the study if they have a history or current diagnosis of dislocation with an associated positive apprehension test, rotator cuff tears/rupture, adhesive capsulitis, acromioclavicular joint pathology, cervical spine pathology, neurological pathology, systemic disease affecting the upper limb (e.g. cancer or rheumatological disease), heart failure, radiological/imaging findings of internal derangement of the glenohumeral joint, bilateral upper limb pain, trauma to the upper limb within the previous four weeks, or physiotherapy treatment for this condition within the last six month (Desmeules et al., 2003).

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)
Person is referred to the physiotherapy department and is screened using a screening form. They are then randomly assigned a treatment sequence A. intervention B. Stretch C. Placebo and following this preliminary study will be randomly assigned to an intervention group and a control group. they and the primary tester will be blinded to allocation via sealed opaque envelopes for the preliminary study and contacting the holder of the allocation schedule who was "off-site".
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
a computer generated randomisation sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Subjects and assessor are blinded in this study
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2459 0
Government body
Name [1] 2459 0
Queensland Health
Country [1] 2459 0
Australia
Primary sponsor type
Government body
Name
Queensland Health
Address
Country
Australia
Secondary sponsor category [1] 2232 0
None
Name [1] 2232 0
Nil
Address [1] 2232 0
Country [1] 2232 0

Ethics approval
Ethics application status
Not yet submitted

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

Contacts
Principal investigator
Name 27730 0
Address 27730 0
Country 27730 0
Phone 27730 0
Fax 27730 0
Email 27730 0
Contact person for public queries
Name 11105 0
Rod Ellem
Address 11105 0
GCH Physiotherapy Department
108 Nerang St
Southport QLD 4215
Country 11105 0
Australia
Phone 11105 0
0434566081
Fax 11105 0
Email 11105 0
[email protected]
Contact person for scientific queries
Name 2033 0
Leanne Bisset
Address 2033 0
School of Physiotherapy and Exercise Science
Griffith University
Gold Coast
PMB 50 Gold Coast Mail Centre
QLD 9726
Country 2033 0
Australia
Phone 2033 0
07-5552 7717
Fax 2033 0
Email 2033 0
[email protected]

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.