Clinical trial NCT03796832: Footwear and Exercise for Knee Osteoarthritis (FiREwORK Trial)
Official title: The FiREwORK Trial - Self-management With FootweaR Combined With Exercise for OsteoaRthritis (OA) at the Knee: a Phase II Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee Osteoarthritis
Exercise Therapy
Shoes
Pain
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Universiteit Antwerpen
First posted: 2019-01-08
Enrollment: 97
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a mono-centre randomized controlled trial with a 1:1 allocation into the experimental treatment (exercise therapy and Flat Flexible Shoes) and comparator treatment (exercise therapy and Stable Supportive Shoes). Exercise therapy will consist of supervised facility- and home-based exercises for 3 months (primary time point) and unsupervised home-based exercises for a subsequent 6 months (secondary time point).
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in severity of knee pain on walking
timeFrame: Measured at baseline, 13 and 37 weeks
Secondary outcomes:
measure: Severity of intercondylar synovitis
timeFrame: Measured at baseline, 13 and 37 weeks
measure: Severity of whole knee effusion
timeFrame: Measured at baseline, 13 and 37 weeks
measure: Severity of bone marrow lesions
timeFrame: Measured at baseline, 13 and 37 weeks
measure: Severity of physical dysfunction
timeFrame: Measured at baseline, 13 and 37 weeks
measure: Severity of knee pain overall
timeFrame: Measured at baseline, 13 and 37 weeks
measure: Participant-perceived global change in pain
timeFrame: Measured at 13 and 37 weeks
measure: Participant-perceived global change in physical function
timeFrame: Measured at 13 and 37 weeks
measure: Participant-perceived global change overall
timeFrame: Measured at 13 and 37 weeks
measure: Average Daily Step Count
timeFrame: Measured during weeks 1, 12 and 36
measure: Habitual physical activity level
timeFrame: Measured at baseline, 13 and 37 weeks
measure: Health-related quality of life
timeFrame: Measured at baseline, 13 and 37 weeks
Other outcomes:
measure: Adherence to shoe usage
timeFrame: Measured by pedometer at week 1, week 12, week 37, and by logbooks at month 1 , month 2, month 3, month 4, month 5, month 6, month 7, month 8, month 9
measure: Adherence to exercise therapy
timeFrame: Measured at week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12 and month 4, month 5, month 6, month 7, month 8, month 9
measure: Adverse events, co-interventions including medication use
timeFrame: Measured at baseline, 13 and 37 weeks
measure: Knee joint loading - lower limb kinetics and kinematics
timeFrame: Measured at baseline, 13 and 37 weeks
measure: Markers of local synovial inflammation - synovial hypertrophy and Doppler activity
timeFrame: Measured at baseline, 13 and 37 weeks
measure: Neuropathic pain
timeFrame: Measured at baseline, 13 and 37 weeks
measure: Foot posture
timeFrame: Measured at baseline, 13 and 37 weeks
measure: Location of knee pain
timeFrame: Measured at baseline, 13 and 37 weeks
measure: Numbers of participants dropped out from study
timeFrame: From baseline to 9 months
measure: Peripheral sensitization (thermal)
timeFrame: Measured at baseline, 13 and 37 weeks
measure: Widespread sensitization (thermal)
timeFrame: Measured at baseline, 13 and 37 weeks
measure: Pain sensitivity (local)
timeFrame: Measured at baseline, 13 and 37 weeks
measure: Pain sensitivity (peripheral)
timeFrame: Measured at baseline, 13 and 37 weeks
measure: Peripheral sensitization (mechanical)
timeFrame: Measured at baseline, 13 and 37 weeks
measure: Widespread sensitization (mechanical)
timeFrame: Measured at baseline, 13 and 37 weeks
measure: Dysfunctional endogenous analgesia
timeFrame: Measured at baseline, 13 and 37 weeks
measure: Dysfunctional endogenous analgesia
timeFrame: Measured at baseline, 13 and 37 weeks
measure: Central sensitization
timeFrame: Measured at baseline, 13 and 37 weeks
Locations:
city: Ghent
country: Belgium
facility: Ghent University, Department of Rehabilitation Sciences
Study officials:
affiliation: University Ghent
name: Patrick Calders, PhD
role: PRINCIPAL_INVESTIGATOR
References: