Footwear and Exercise for Knee Osteoarthritis (FiREwORK Trial)
- Conditions
- Knee Osteoarthritis
- Interventions
- Device: Stable Supportive ShoesDevice: Flat Flexible ShoesOther: Exercise Therapy
- Registration Number
- NCT03796832
- Lead Sponsor
- University Ghent
- Brief Summary
Osteoarthritis (OA) is a chronic degenerative joint disease and leading cause of musculoskeletal pain and disability worldwide. The high rates of knee replacement surgery worldwide emphasize the need for more effective non-surgical interventions to attenuate progressive disability. International scientific and professional societies also propose that therapies need to seek efficacious combinations of modalities with the ultimate aim to achieve longer-term, optimal and synergistic treatment effects.
Exercise therapy, such as strengthening and aerobic exercise, is universally, and strongly, recommended as it demonstrates beneficial effects on clinical symptoms and is considered safe for all patients with knee OA. However, during activities as simple as walking, higher knee joint loads have been demonstrated in people with medial tibiofemoral OA, a common form of knee OA. Increased joint loading as such may elicit aggravated symptoms and accelerated joint structural decline over time. No convincing evidence exists to confirm exercise therapy effectively alters joint loading parameters during walking gait in people with knee OA. Notably, recent studies suggest that wearing appropriate footwear may help offload the joint in people with knee OA, a strategy that is also easily applicable at a wide population level.
The purpose of this clinical study is to compare 9-month treatment consisting of exercise therapy and daily wear of one of two shoe classes (flat flexible shoes or stable supportive shoes), on symptom relief and joint structural damage in people with knee OA. In this study, we will randomly allocate eligible participants in one of two treatment arms. This means there will be an equal amount of participants in each group, and participants nor researchers will be able to choose in which group participants will end up in.Participants in both groups will enroll in a 9 month exercise program and will be provided a pair of one of the two shoe classes to wear daily. To ensure an unbiased appraisal of treatment effects, we will not disclose the study hypotheses to participants during the intervention period.
The results of this study will help determine whether the addition of appropriate footwear to exercise therapy improves symptom relief and/or slows structural disease progression in people with knee OA.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 97
- Symptomatic and radiographic diagnosis of knee OA as per the American College of Rheumatology criteria (ie, aged≥50, knee pain on most days and osteophytes)
- Radiographic evidence of medial OA (ie, Kellgren Lawrence(KL) grade ≥2, ≥grade 1 medial joint space narrowing (JSN) (scale 0-3)> lateral JSN, using a standardized atlas)
- Average knee pain on walking over the past week of ≥4 on a 11-point numeric rating scale (NRS; "0=no pain" to "10=worst pain imaginable")
- Ability to walk unaided
- Willing to comply with therapy prescriptions
- Sufficient understanding of the Dutch language
- Current and previous (3 months) participation in exercise therapy
- Current and previous (3 months) use of customised footwear, minimalist shoes, insoles, braces and unable/unwilling to abandon during the study
- Knee surgery in either knee and/or injections (corticosteroids, hyaluronic acid) in the study knee (most painful knee or right knee if both equally painful) in the past 6 months
- Current or recent (4 weeks) use of oral corticosteroids
- Knee replacement or high tibial osteotomy surgery in the past, or planned during the study
- Inflammatory arthropathies
- Other muscular, joint, neurological or metabolic conditions affecting lower limb function and/or precluding safe regular participation in exercise therapy and walking
- Body mass index (BMI) of >36 kg/m2 (due to difficulties performing gait analysis and MRI)
- Foot/ankle pain/pathologies at either side, and worse than knee pain complaints
- Contra-indications for radiography & MRI
- Use of supplements (eg, glucosamine, chondroitin, curcuma derivates) or pain medication (NSAIDs, paracetamol) or other disease modifying or anti-bone resorptive drugs if participants were not on a stable dose for ≥2 months prior to entering the trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stable Supportive Shoes+Exercise Therapy Stable Supportive Shoes This arm will wear Stable Supportive Shoes daily for the duration of 9 months combined with supervised facility-based and home-based exercise therapy (months 0-3) and unsupervised home-based exercise therapy (months 4-9). Flat Flexible Shoes+Exercise Therapy Flat Flexible Shoes This arm will wear Flat Flexible Shoes daily for the duration of 9 months combined with supervised facility-based and home-based exercise therapy (months 0-3) and unsupervised home-based exercise therapy (months 4-9). Flat Flexible Shoes+Exercise Therapy Exercise Therapy This arm will wear Flat Flexible Shoes daily for the duration of 9 months combined with supervised facility-based and home-based exercise therapy (months 0-3) and unsupervised home-based exercise therapy (months 4-9). Stable Supportive Shoes+Exercise Therapy Exercise Therapy This arm will wear Stable Supportive Shoes daily for the duration of 9 months combined with supervised facility-based and home-based exercise therapy (months 0-3) and unsupervised home-based exercise therapy (months 4-9).
- Primary Outcome Measures
Name Time Method Change in severity of knee pain on walking Measured at baseline, 13 and 37 weeks Scored on an 11-point numeric rating scale for average knee pain on walking over the past week, with terminal descriptors of "0=no pain" to "10=worst pain imaginable".
- Secondary Outcome Measures
Name Time Method Severity of intercondylar synovitis Measured at baseline, 13 and 37 weeks Graded using the MRI Osteoarthritis Knee Score hoffa-synovitis sub-score, ranging grade 0 (normal) to grade 3 (severe).
Severity of bone marrow lesions Measured at baseline, 13 and 37 weeks Graded using the MRI Osteoarthritis Knee Score bone marrow lesion sub-score, grade 0 (none) to grade 3 (\>66% of subregional volume).
Severity of whole knee effusion Measured at baseline, 13 and 37 weeks Graded using the MRI Osteoarthritis Knee Score effusion-synovitis sub-score, ranging grade 0 (physiologic amount) to grade 3 (large - evidence of capsular distention).
Severity of physical dysfunction Measured at baseline, 13 and 37 weeks Measured with the function subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index. This sub-scale gives a range of possible scores from "0=no dysfunction" to "68=maximum dysfunction".
Participant-perceived global change in pain Measured at 13 and 37 weeks Scored on a 7-point ordinal scale (with terminal descriptors of "1=much worse" to "7=much better"). Participants who report they are "moderately better" and above will be classified as "improved".
Participant-perceived global change in physical function Measured at 13 and 37 weeks Scored on a 7-point ordinal scale (with terminal descriptors of "1=much worse" to "7=much better"). Participants who report they are "moderately better" and above will be classified as "improved".
Participant-perceived global change overall Measured at 13 and 37 weeks Scored on a 7-point ordinal scale (with terminal descriptors of "1=much worse" to "7=much better"). Participants who report they are "moderately better" and above will be classified as "improved".
Average Daily Step Count Measured during weeks 1, 12 and 36 Measured using a pedometer attached to the hip for 7 subsequent days to assess objective physical activity.
Habitual physical activity level Measured at baseline, 13 and 37 weeks Measured using the Physical Activity Scale for the Elderly with scores ranging 0-400 where higher scores indicate greater physical activity.
Severity of knee pain overall Measured at baseline, 13 and 37 weeks Scored on an 11-point numeric rating scale for average knee pain overall the past week, with terminal descriptors of "0=no pain" to "10=worst pain imaginable".
Health-related quality of life Measured at baseline, 13 and 37 weeks Measured using the EuroQoL Quality of Life Scale (EQ-5D) with scores ranging from 0 to 100 (higher scores indication better health-related quality of life).
Trial Locations
- Locations (1)
Ghent University, Department of Rehabilitation Sciences
🇧🇪Ghent, Belgium