Not available
ACTRN12619001240134
Government body, National Health and Medical Research Council (NHMRC)
Prof Rana Hinman
We are conducting a clinical trial to compare the clinical effectiveness and cost-effectiveness of different modes of delivering physiotherapy care to people with knee OA. Participants will undergo five consultations with a physiotherapist over 3 months (30-45 minutes) for prescription of a home-based strengthening exercise program and physical activity plan (to be conducted independently at home), as well as OA education, after which participants will be reassessed remotely via paper or web-bas .... Read more
i) meet National Institute for Health and Care Excellence clinical criteria for knee OA: i. age 45 years or older; ii. activity-related knee joint pain; iii. morning knee stiffness lasting no more than 30 mins, ii) report history of knee pain of at least 3mths duration; iii) report knee pain on most days of the past month; iv) report an average pain score of at least 4 on an 11-point numeric rating scale during walking over the previous week; v) report difficulty walking and climbing stairs; vi) .... Read more
i) inability to speak English; ii) on waiting list for/planning knee/hip surgery in next 12 months; iii) previous arthroplasty on affected knee; iv) recent knee surgery (past 6 months); v) consulting/ed physiotherapy or doing strengthening exercise for knee (past 6 months); vi) self-reported inflammatory arthritis (e.g. rheumatoid arthritis); vii) any neurological condition affecting lower limbs; and/or viii) any unstable/uncontrolled cardiovascular condition. Clearance to participate from a gen .... Read more
No
Sample Size 394
Min. age 45 Years
Max. age No limit
Sex Both males and females
Condition category Knee osteoarthritis
Condition code Musculoskeletal , Physical Medicine / Rehabilitation
Intervention code Treatment: Other , Rehabilitation
Participants will undergo five one-on-one i) face-to-face or; ii) video consultations with a physiotherapist over 3 months (at approximately weeks 1, 2, 4, 7, 10) each lasting 30 minutes except the first which will be 45 mins. The consultations will involve the prescription of a home-based strengthening exercise program and physical activity plan (to be conducted independently at home), as well as OA education. Physiotherapists will prescribe 5-6 strengthening exercises to be performed at home t .... Read more
Control group Active
The study is comparing the two modes of physiotherapy delivery.
Outcome: Severity of knee pain during walking Scored on an 11-point NRS for average pain on walking in the last weekTimepoint: Baseline, 3 months
Outcome: Self-reported physical function assessed by Western Ontario & McMaster Osteoarthritis Index (WOMAC) physical function sub-scaleTimepoint: Baseline, 3 months
Yes
Data will be made available to researchers as required for specific, approved analyses. Data will be provided from locked, cleaned, and de- identified study database. Requests will be reviewed by the Principal Investigator prior to approval.
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Individual participant data not covered above
All data presented in the results paper will be made available for sharing (DOI:https://doi.org/10.1016/S0140-6736(23)02630-2)
The investigators endorse the concept of data sharing to advance medical science. All requests for data sharing will be reviewed by the Principal Investigator to ensure no conflict with any planned sub analyses and to ensure that the data are shared in an ethical and protected manner. Analyses aimed to improve treatment of knee osteoarthritis for non-commercial purposes are eligible.
No
From: 07/03/2024
To: 07/03/2039 (a period of 15 years from publication)
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