Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000224527
Ethics application status
Approved
Date submitted
1/06/2006
Date registered
2/06/2006
Date last updated
2/06/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Joint mobilisation and water exercise for quality of life in osteoarthritis
Scientific title
The effects of joint mobilisation and water exercise on health-related quality of life in people with osteoarthritis
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 1202 0
Condition category
Condition code
Musculoskeletal 1286 1286 0 0
Osteoarthritis

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

Duration: 10 weeks (one Victorian school term)
Frequency of intervention: single therapy groups = one session (approx 40 minutes) per week, combined therapy group = 2 sessions (approx 40 minutes) per week.
Four group comparison of the effects of usual care with manual therapy and / or water exercise adjunctive to usual care on the health-related quality of life of people with osteoarthritis.
Intervention code [1] 1057 0
Treatment: Other
Comparator / control treatment
Control group: usual care
Control group
Active

Outcomes
Primary outcome [1] 1746 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] 1746 0
Measures taken at baseline, weeks 5, 9, 12, 24
Primary outcome [2] 1747 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] 1747 0
Measures taken at baseline, weeks 5, 9, 12, 25
Secondary outcome [1] 3100 0
General health-related quality of life
Timepoint [1] 3100 0
Measured using the Medical Outcomes Study 36-Item health survey (SF-36).
Secondary outcome [2] 3101 0
Returns scores on 9 quality of life domains.
Timepoint [2] 3101 0
Secondary timepoints, baseline, week 5 of 10 week intervention. (Measures taken at baseline, weeks 5, 9, 12, 24).

Eligibility
Key inclusion criteria
Able to walk 20 metres unaided, able to dress / undress self, able to get in and out of swimming pool unaided, 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
Small sample size - results interpretted in terms of clinically important effect sizes not statistical significance.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
22
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1413 0
University
Name [1] 1413 0
Victoria University
Country [1] 1413 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
Country
Australia
Secondary sponsor category [1] 1239 0
Charities/Societies/Foundations
Name [1] 1239 0
Arthritis Victoria
Address [1] 1239 0
Country [1] 1239 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2770 0
Victoria University
Ethics committee address [1] 2770 0
Ethics committee country [1] 2770 0
Australia
Date submitted for ethics approval [1] 2770 0
Approval date [1] 2770 0
27/02/2003
Ethics approval number [1] 2770 0
HRETH.FHD.045/01

Summary
Brief summary
Third study in a series of three pilot clinical trials. Four way comparison of the effects of manual therapy (joint mobilisation), water exercise, and both interventions 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 35568 0
Address 35568 0
Country 35568 0
Phone 35568 0
Fax 35568 0
Email 35568 0
Contact person for public queries
Name 10246 0
Melainie Cameron
Address 10246 0
VIctoria University
PO Box 14428
Melbourne MC VIC 8001
Country 10246 0
Australia
Phone 10246 0
+61 3 99194287
Fax 10246 0
+61 3 99194891
Email 10246 0
[email protected]
Contact person for scientific queries
Name 1174 0
Melainie Cameron
Address 1174 0
Victoria University
PO Box 14428
Melbourne MC VIC 8001
Country 1174 0
Australia
Phone 1174 0
+61 3 99194287
Fax 1174 0
+61 3 99194891
Email 1174 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
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