Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000226505
Ethics application status
Approved
Date submitted
1/06/2006
Date registered
5/06/2006
Date last updated
5/06/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Manual therapies for osteoarthritis: A pilot study
Scientific title
Massage and joint mobilisation for improving quality of life in people with osteoarthritis: A pilot study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 1204 0
Condition category
Condition code
Musculoskeletal 1289 1289 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention groups: massage adjunct to usual care, joint mobilisation adjunct to usual care

Duration: 10 weeks (one Victorian school term)
Frequency of intervention: one session (approx 40 minutes) per week
Three group comparison of the effects of usual care with 2 types of manual therapy adjunctive to usual care on the health-related quality of life of people with osteoarthritis.
Intervention code [1] 1056 0
Treatment: Other
Comparator / control treatment
Control group: usual care
Control group
Active

Outcomes
Primary outcome [1] 1754 0
Pain: measured using short-form McGill Pain Questionnaire, returns scores for sensory pain, affective pain, total pain, present pain index, and visual analogue pain scale.

Primary timepoint week 9 of 10 week intervention.
Timepoint [1] 1754 0
Measures taken at baseline, week 5, week 9
Primary outcome [2] 1755 0
Arthritis-specific quality of life, measured using the Arthritis Impact Measurement Scales version 2 (AIMS2).

Primary timepoint week 9 of 10 week intervention.
Timepoint [2] 1755 0
Measures taken at baseline, week 5, week 10
Secondary outcome [1] 3103 0
General health-related quality of life.
Timepoint [1] 3103 0
Measured using the Medical Outcomes Study 36-Item health survey (SF-36).
Secondary outcome [2] 3104 0
Returns scores on 9 quality of life domains.
Timepoint [2] 3104 0
Secondary timepoints, baseline, week 5 of 10 week intervention. (Measures taken at baseline, week 5, week 9).

Eligibility
Key inclusion criteria
Able to walk 20 metres unaided, able to dress / undress self, able to read / write in English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Substantive co-morbidity, development / diagnosis of co-morbidity during intervention period.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random number table
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Pilot study of small sample size - results intpretted in terms of clinically meaningful effect sizes rather than statistical significance.
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
19
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1415 0
University
Name [1] 1415 0
Victoria University
Country [1] 1415 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
Country
Australia
Secondary sponsor category [1] 1241 0
None
Name [1] 1241 0
nil
Address [1] 1241 0
Country [1] 1241 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2771 0
Victoria University
Ethics committee address [1] 2771 0
Ethics committee country [1] 2771 0
Australia
Date submitted for ethics approval [1] 2771 0
Approval date [1] 2771 0
27/02/2003
Ethics approval number [1] 2771 0
HRETH.FHD.045/01

Summary
Brief summary
First study in a series of three pilot clinical trials. Three way comparison of the effects of 2 manual therapies adjunctive to usual care with usual care alone on health-related quality of life in people with osteoarthritis. Study is complete. Trial registration is required in order to publish a report of the trial in a journal.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36093 0
Address 36093 0
Country 36093 0
Phone 36093 0
Fax 36093 0
Email 36093 0
Contact person for public queries
Name 10245 0
Dr Melainie Cameron
Address 10245 0
Victoria University
School of HMRP
PO Box 14428
Melbourne MC 8001
Country 10245 0
Australia
Phone 10245 0
+61 3 9919 4287
Fax 10245 0
+61 3 9919 4891
Email 10245 0
[email protected]
Contact person for scientific queries
Name 1173 0
Dr Melainie Cameron
Address 1173 0
Victoria University
School of HMRP
PO Box 14428
Melbourne MC 8001
Country 1173 0
Australia
Phone 1173 0
+61 3 9919 4287
Fax 1173 0
+61 3 9919 4891
Email 1173 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.