Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000080426
Ethics application status
Approved
Date submitted
28/12/2006
Date registered
23/01/2007
Date last updated
23/01/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Multidisciplinary osteoarthritis of the knee study
Scientific title
To compare the effectiveness of an osteoarthritis of the knee self-management program delivered by health professionals with a control group, as determined by improvements in pain, quality of life and physical function
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the knee 1572 0
Condition category
Condition code
Musculoskeletal 1673 1673 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group completed the 8-week self-management education program that included specific exercises with instruction tailored for OA of the knee. Self-management aims to motivate people to undertake the changes in behaviour necessary to improve their lives. For some people that may involve moving from a very sedentary lifestyle to one of mild activity (and hopefully progressing to more activity). Another person may already have a very active lifestyle involving a lot of aerobic activity, but little else. They may be motivated to include strengthening and/or balance exercises to their regimen.

Within each group of participants there will be a wide spread and it is up to the individual to decide what they consider to be important enough to model (copy) from the program. The information that is given throughout the course is based on principles of exercise, with demonstrations given throughout so that participants clearly understand what type of exercise involves what type of activity- to clarify, they will understand the difference between balance, strengthening, aerobic and flexibility exercise and the implications of each.

This program is NOT an exercise class. It does not go into a gym, or a hydrotherapy pool etc, however the principles of different types of exercise are certainly part of the program. Since it is not an exercise class, though exercise is a component of it (and participants may choose to try new exercises as part of their weekly goal setting), along with pain management, use of analgesia, medications, dealing with negative emotions- our outcome measures reflect quality of life, pain, and function.
Intervention code [1] 1527 0
Treatment: Other
Comparator / control treatment
The control group had a 6 month waiting period before receiving the OA knee program.
Control group
Active

Outcomes
Primary outcome [1] 2316 0
Health status, measured using the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis index.
Timepoint [1] 2316 0
All outcomes were measured at baseline, 8 weeks, 6 months and 12 months.
Primary outcome [2] 2317 0
Quality of life, measured using the Short Form 36 (SF36) questionnaire Version 1.
Timepoint [2] 2317 0
All outcomes were measured at baseline, 8 weeks, 6 months and 12 months.
Primary outcome [3] 2318 0
Pain, measured using a Visual Analog Scale (VAS).
Timepoint [3] 2318 0
All outcomes were measured at baseline, 8 weeks, 6 months and 12 months.
Primary outcome [4] 2319 0
Knee function, measured using the Functional Knee Assessment Test (FKAT).
Timepoint [4] 2319 0
All outcomes were measured at baseline, 8 weeks, 6 months and 12 months.
Secondary outcome [1] 4042 0
Range of movement of the knee joints, measured using a long armed Goniometer.
Timepoint [1] 4042 0
All outcomes were measured at baseline, 8 weeks, 6 months and 12 months.
Secondary outcome [2] 4043 0
Quadriceps and hamstrings muscle strength, measured using the Fixed Mecmesin Basic Force Gauge Dynamometer.
Timepoint [2] 4043 0
All outcomes were measured at baseline, 8 weeks, 6 months and 12 months.

Eligibility
Key inclusion criteria
Inclusion criteria: Established OA of one or both knees diagnosed either by clinical examination or by radiological (x-ray) evidence by a general practitioner (GP) or specialist physician.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: Those participants with rheumatoid arthritis, or other inflammatory joint disease, who plan to have knee surgery within 6 months of commencing the study, or have physical impairments that preclude them from fulfilling the requirements of the program.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Pre-made cards will be placed each in a sealed, opaque envelope. These will then be placed in an enclosed box. After a subject has signed informed consent, the box will be opened and an envelope containing a randomisation card will be chosen by a third party to determine which treatment the subject will receive.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be allocated to groups using simple randomisation procedures such as coin tossing
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Those who volunteer for the study will be randomised to an immediate start (intervention group) or a delayed start 6 months later (control group). Group participants will be aware of which group they have been randomised to. The physiotherapists doing assessments for outcome measures will be unaware of group allocation of participants. For ethical reasons those volunteers randomised to the control group will be offered the program at the conclusion of the 6 month study
Phase
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
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1818 0
Charities/Societies/Foundations
Name [1] 1818 0
Arthritis WA
Country [1] 1818 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Arthritis WA
Address
Country
Australia
Secondary sponsor category [1] 1640 0
Individual
Name [1] 1640 0
Dr N.K Briffa, Curtin University of Technology
Address [1] 1640 0
Country [1] 1640 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3407 0
Curtin University of Technology.
Ethics committee address [1] 3407 0
Ethics committee country [1] 3407 0
Australia
Date submitted for ethics approval [1] 3407 0
Approval date [1] 3407 0
Ethics approval number [1] 3407 0
HR141

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27461 0
Address 27461 0
Country 27461 0
Phone 27461 0
Fax 27461 0
Email 27461 0
Contact person for public queries
Name 10716 0
Sophie Coleman
Address 10716 0
Arthritis WA
PO Box 34
Wembley WA 6914
Country 10716 0
Australia
Phone 10716 0
+61 8 93884412
Fax 10716 0
+61 8 93884488
Email 10716 0
[email protected]
Contact person for scientific queries
Name 1644 0
Dr N K Briffa
Address 1644 0
School of Physiotherapy
Curtin University of Technology
WA
Country 1644 0
Australia
Phone 1644 0
+61 8 92663666
Fax 1644 0
Email 1644 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.