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Trial registered on ANZCTR


Trial ID
ACTRN12605000151639
Ethics application status
Approved
Date submitted
12/08/2005
Date registered
15/08/2005
Date last updated
15/08/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Passive joint mobilisation for the treatment of shoulder pain
Scientific title
An evaluation of the effectiveness of passive mobilisation of shoulder joints for the treatment of shoulder pain: a randomised controlled clinical trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rotator cuff syndrome
242 0
Impingement syndrome 243 0
Painful arc syndrome 244 0
Condition category
Condition code
Alternative and Complementary Medicine 274 274 0 0
Pain management
Musculoskeletal 275 275 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental intervention: advice, exercises and passive joint mobilisations at shoulder region joints
Intervention code [1] 181 0
Treatment: Other
Comparator / control treatment
Control intervention: advice and exercises
Control group
Active

Outcomes
Primary outcome [1] 323 0
* Shoulder Pain and Disability Index questionnaire (SPADI)
Timepoint [1] 323 0
At 1, 3 and 6 months after randomisation
Primary outcome [2] 324 0
* Self-assessed improvement measured on a Likert scale consisting of the following 6 categories: much worse, slightly worse, same, slightly improved, greatly improved, and fully recovered
Timepoint [2] 324 0
At 1, 3 and 6 months after randomisation
Secondary outcome [1] 723 0
Painful active abduction and flexion range of motion.
Timepoint [1] 723 0
At 1, 3 and 6 months after randomisation.

Eligibility
Key inclusion criteria
Subjects will be included if they have pain over the glenohumeral joint or in the proximal upper limb during shoulder movements and maintenance of at least 75% of normal active abduction and flexion range of movement.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects will be excluded from the study if: shoulder symptoms are exacerbated during active cervical movements with and/or without overpressure and/or during cervical or thoracic region palpation; they are complaining of parathesia in the affected upper limb; passive shoulder joint mobilisation is contra-indicated; shoulder forward flexion and/or abduction is less than 75% active range of movement; shoulder pain is due to an inflammatory or neoplastic disorder; they have had surgery or trauma to the shoulder in the previous 4 weeks; or they are experiencing a feeling of shoulder instability.

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)
numbered envelopes - concealed allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random numbers generated using the "rand()" function in Microsoft Excel
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
blinded assessmenrt used
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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 in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 329 0
Self funded/Unfunded
Name [1] 329 0
Address [1] 329 0
Country [1] 329 0
Primary sponsor type
Individual
Name
Dr Karen Ginn
Address
Country
Secondary sponsor category [1] 262 0
Individual
Name [1] 262 0
Dr Meg Stuart
Address [1] 262 0
Country [1] 262 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1264 0
Royal Prince Alfred Hospital Sydney University of Sydney
Ethics committee address [1] 1264 0
Ethics committee country [1] 1264 0
Australia
Date submitted for ethics approval [1] 1264 0
Approval date [1] 1264 0
Ethics approval number [1] 1264 0

Summary
Brief summary
Forty subjects presenting with pain during shoulder movements will be recruited for this study. Subjects will be randomly allocated into either a control or experimental group. Both groups will receive advice and shoulder exercises. The experimental group will additionally receive passive shoulder joint mobilisation. Outcome measurements of pain intensity, functional impairment, self assessment of improvement and active range of movement will be re-assessed by a blinded researcher at 1, 3 and 6 months following recruitment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36020 0
Address 36020 0
Country 36020 0
Phone 36020 0
Fax 36020 0
Email 36020 0
Contact person for public queries
Name 9370 0
Dr Karen Ginn
Address 9370 0
University of Sydney
Cumberland Campus
PO Box 170
Lidcombe NSW 1825
Country 9370 0
Australia
Phone 9370 0
+61 2 93519352
Fax 9370 0
Email 9370 0
K.Ginn@fhs.usyd.edu.au
Contact person for scientific queries
Name 298 0
Dr Karen Ginn
Address 298 0
University of Sydney
Cumberland Campus
PO Box 170
Lidcombe NSW 1825
Country 298 0
Australia
Phone 298 0
+61 2 93519352
Fax 298 0
Email 298 0
K.Ginn@fhs.usyd.edu.au