Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000080628
Ethics application status
Approved
Date submitted
27/07/2005
Date registered
5/08/2005
Date last updated
11/03/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Passive joint mobilisation for the treatment of shoulder pain and stiffness
Scientific title
The effect of passive joint mobiisation on shoulder pain and disability in the treatment of shoulder pain and stiffness
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rotator cuff syndrome
 155 0
Impingement syndrome 156 0
Frozen shoulder 157 0
Condition category
Condition code
Musculoskeletal 175 175 0 0
Other injuries and accidents
Musculoskeletal 176 176 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
* experimental intervention: advice, exercises and passive mobilisations at shoulder region joints
Intervention code [1] 72 0
Treatment: Other
Comparator / control treatment
* control intervention: advice and exercises
Control group
Active

Outcomes
Primary outcome [1] 213 0
Shoulder Pain and Disability Index (SPADI)
Timepoint [1] 213 0
1 month and 6 months after randomisation
Primary outcome [2] 3379 0
Self-assessed improvement measured on a Likert scale consisting of the following 6 categories: completely recovered; significantly improved; slightly improved; no change; slightly deteriorated; significantly deteriorated
Timepoint [2] 3379 0
1 month and 6 months
Secondary outcome [1] 489 0
Active abduction and flexion range measured via photography and hand-behind-back range measured using a tape measure.
Timepoint [1] 489 0
1 month and 6 months

Eligibility
Key inclusion criteria
Subjects will be included if they have a unilateral shoulder problem of local mechanical origin. This will be defined as pain over the glenohumeral joint or in proximal upper limb during shoulder movements and restriction of greater than 30 degrees active flexion or abduction range or greater than 10cm active hand-behind-back range compared to unaffected side.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects will be excluded if their shoulder problem is due to trauma in last month, if they have an acute inflammatory or local neoplastic disorder, if they complain of a feeling of instability at the glenohumeral joint during active shoulder movements or if passive mobilisation of the joints of the shoulder region is contra-indicated. Subjects will also be excluded if their shoulder pain is referred from vertebral column structures. Referred pain will be defined as pain over the glenohumeral joint or in the proximal upper limb during active neck movements or during palpation of cervicothoracic vertebral column or complaining of paraesthesiae in affected upper limb.

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 by Microsoft Excel. Allocation was not stratified but it is blocked.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 232 0
Charities/Societies/Foundations
Name [1] 232 0
Physiotherapy Research Foundation
Country [1] 232 0
Australia
Primary sponsor type
Hospital
Name
Prince of Wales Hospital - Sydney
Address
Barker Street, Randwick, NSW
Country
Australia
Secondary sponsor category [1] 172 0
University
Name [1] 172 0
University of Sydney
Address [1] 172 0
Esat Strret, Lidcombe, NSW
Country [1] 172 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
90 volunteers presenting for treatment at a public hospital outpatient department with restricted, painful shoulder dysfunction will be recruited. Following an initial examination to obtain baseline data subjects will be randomly allocated to one of two treatment groups: advice and exercises or advice, exercises and passive joint mobilisations. Subjects will attend between 4 and 8 treatment sessions over a one month period. Outcome measurements will then be re-assessed. Following re-assessment treatment may continue for a maximum of 10 treatment sessions over a maximum of 8 weeks. Re-assessment will be repeated 6 months after recruitment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35609 0
Address 35609 0
Country 35609 0
Phone 35609 0
Fax 35609 0
Email 35609 0
Contact person for public queries
Name 9261 0
Dr Karen Ginn
Address 9261 0
University of Sydney
Cumberland Campus
PO Box 170
Lidcombe NSW 1825
Country 9261 0
Australia
Phone 9261 0
+61 2 93519352
Fax 9261 0
Email 9261 0
[email protected]
Contact person for scientific queries
Name 189 0
Dr Karen Ginn
Address 189 0
University of Sydney
Cumberland Campus
PO Box 170
Lidcombe NSW 1825
Country 189 0
Australia
Phone 189 0
+61 2 93519352
Fax 189 0
Email 189 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.