Better Knee, Better Me: effectiveness of two scalable health care interventions supporting self-management for knee osteoarthritis – a randomised controlled trial.
- Conditions
- knee osteoarthritisMusculoskeletal - Osteoarthritis
- Registration Number
- ACTRN12618000930280
- Lead Sponsor
- The University of Melbourne
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 415
Our selection criteria are consistent with a clinical diagnosis of osteoarthritis from both the National Institute for Health and Care Excellence (NICE) and the Australian Clinical Care Standard for reaching diagnosis of knee osteoarthritis). Specific inclusion criteria are:
1.Aged between 45 and 80 years
2.Reports activity-related knee joint pain
3.Reports morning knee stiffness less than or equal to 30 minutes;
4.History of knee pain on most days for 3 months or more;
5.Overall average knee pain in past week self-rated as 4 or more out of 10 on an 11-point numeric rating scale;
6.Body mass index (BMI) greater than or equal to 28 kg/m2 and < 41 kg/m2;
7.Member of Medibank Private with a level of cover that includes arthroplasty surgery;
8.Able to give informed consent and to participate fully in the interventions and assessment procedures;
9.Willing to follow advice for self-management, participate in exercise/physical activity and/or participate in the weight loss program if part of their treatment program; and
10.Have the ability to regularly weigh themselves (e.g. have access to a set of bathroom scales).
1.Booked for knee surgery on either knee;
2.Have had all eligible knee joints replaced (i.e. bilateral replacements or unilateral replacement with non-operated knee pain < 4 out of 10);
3.Recent knee surgery within the past 6 months;
4.Unable to speak English or unable read English;
5.Self-reported diagnosis of rheumatoid arthritis or other inflammatory arthritis;
6.Other medical condition or upcoming medical procedures that in the opinion of the research staff and/or investigators would preclude participation;
7.Unable to use/access telephone and internet;
8.For those identified as at risk from the pre-exercise and falls screening, GP does not give clearance;
9.Used low-calorie meal replacement products (e.g. Optifast /Optislim) for weight loss in previous 6 months;
10.Currently, or during the past 6 months, undertaking regular strengthening exercise for the knee or;
11.Unable to undertake Very Low Energy/ketogenic diet for medical reasons including:
a.Self-reported diagnosis of Type 1 diabetes
b.Self-reported Type 2 diabetes requiring insulin or other medication apart from metformin
c.Self-reported warfarin use
d.Stroke or cardiac event in previous 6 months
e.Unstable heart condition
f.Fluid intake restriction.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Average overall knee pain.<br>Self-reported, using an 11-point numeric rating scale for Average overall knee pain in the last week” where 0=No pain” and 10=Worst pain possible”.<br>[Measured at baseline, 6 months and 12 months with the primary time point being 6 months. ];Physical function.<br>Self-reported, using the Western Ontario & McMaster University Osteoarthritis Index (WOMAC) Physical Function subscale..<br>[Measured at baseline, 6 months and 12 months with the primary time point being 6 months. ]
- Secondary Outcome Measures
Name Time Method