None listed
Conditions
Brief summary
Ankle osteoarthritis is a debilitating condition that affects individuals of working age and is characterised by high levels of pain and disability. However, very little is known about how to manage ankle osteoarthritis. While education and exercise interventions have been shown to be successful in the management of hip and knee osteoarthritis, such an intervention has not been investigated in ankle osteoarthritis. The proposed study will establish the feasibility and credibility of a combined education and exercise intervention for ankle osteoarthritis. Secondary outcomes will explore whether education and exercise can improve pain, stiffness, function, and quality of life in this population. This study will determine the feasibility of conducting a full-scale randomised clinical trial investigating education and exercise in people with ankle osteoarthritis and inform the selection of outcome measures. It is an essential first step in determining the effectiveness of an education and exercise intervention for individuals with ankle osteoarthritis. Study findings have the capacity to change the way ankle osteoarthritis is managed and inform the development of clinical practice guidelines to help clinicians make evidence-based decisions when managing people with ankle osteoarthritis.
Interventions
Education and exercise:
The trial intervention will be delivered by a registered physiotherapist with experience delivering education and exercise interventions to patients with lower limb musculoskeletal conditions. The education and exercise intervention will be delivered in a group setting at a physiotherapy clinic with approximately four participants per group/class. There will be two education sessions which will discuss what osteoarthritis is; the diagnosis and symptoms of ankle osteoarthr
Education and exercise: The trial intervention will be delivered by a registered physiotherapist with experience delivering education and exercise interventions to patients with lower limb musculoskeletal conditions. The education and exercise intervention will be delivered in a group setting at a physiotherapy clinic with approximately four participants per group/class. There will be two education sessions which will discuss what osteoarthritis is; the diagnosis and symptoms of ankle osteoarthritis; recommendations from international guidelines for managing osteoarthritis; research evidence for the treatment of ankle osteoarthritis; Australian physical activity guidelines and tips; and information about the exercise and education intervention that participants will undertake. The education sessions will be guided by a PowerPoint presentation and accompanied by hard copy handouts, both of which have been designed for the intervention. The exercise program will include an aerobic exercise warm up (e.g., cycling on a stationary bike), and exercises to improve foot and ankle muscle strength (e.g., resisted ankle eversion and body weight resisted heel raises), compound lower limb strength and function (e.g., step ups and bridges), and balance (e.g., standing balance exercises). Exercise difficulty/load will be individually evaluated and progressed for each participant. Participants will attend the 2 education sessions and 12 exercise sessions twice weekly over 7 weeks. The 2 education sessions will occur in the first week of the intervention and the 12 exercise sessions will occur twice weekly for the next 6 weeks (e.g., weeks 2-7). Each session will be approximately 1 hour in length. Attendance and exercise completion will be recorded by the treating physiotherapist at each session. Participants will not be given home exercises during the 7-week program, but will be given a home exercise program after the final group exercise session. The home exercise program includes the exercises that participants performed in the group exercise program. Participants will be provided with a handout of the exercises and resistance bands. They will be asked to continue to perform the exercises twice a week (as they did during the group sessions).
Sponsors
The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
a) Aged over 35 years b) Ankle joint pain on most days for the last 3 months c) Severity of pain in the last week greater than or equal to 3 out of 10 on an 11-point numerical rating scale (NRS) anchored with ‘no pain’ at 0 and ‘worst pain imaginable’ at 10 d) Modified Kellgren & Lawrence scale osteoarthritis grade greater than or equal to 2 at the subtalar and/or talocrural joints as determined by assessment of radiographs and defined as presence of osteophytes and/or joint space narrowing e) Committed to undergo the allocated treatment and undertake all follow up outcome measurements f) Able to understand verbal and written English
Exclusion criteria
a) Health problems or pain elsewhere that are more concerning than that at the ankle b) Received exercise and/or education-based treatment for ankle osteoarthritis in the last 3 months c) Previous ankle arthrodesis or total ankle replacement d) Neurological, vestibular or systemic arthritic conditions e) Receiving treatment for cancer f) Inability to undertake radiographic evaluations (e.g. pregnancy) and/or participate in the treatment program
Outcome results
None listed