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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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

Study type
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

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

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
Both males and females
Can healthy volunteers participate?
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
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
Other design features
blinded assessment used
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 232 0
Name [1] 232 0
Physiotherapy Research Foundation
Address [1] 232 0
6/651 Victoria Street, Abbotsford, Victoria
Country [1] 232 0
Primary sponsor type
Prince of Wales Hospital - Sydney
Barker Street, Randwick, NSW
Secondary sponsor category [1] 172 0
Name [1] 172 0
University of Sydney
Address [1] 172 0
Esat Strret, Lidcombe, NSW
Country [1] 172 0

Ethics approval
Ethics application status

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

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
Phone 9261 0
+61 2 93519352
Fax 9261 0
Email 9261 0
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
Phone 189 0
+61 2 93519352
Fax 189 0
Email 189 0

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary