Knee OsteoarthritisFiREwORKNCT03796832
Footwear and Exercise for Knee Osteoarthritis (FiREwORK Trial)
A study testing Flat Flexible Shoes, Stable Supportive Shoes and Exercise Therapy in people with Knee Osteoarthritis, run by University Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Flat Flexible Shoes, Stable Supportive Shoes and Exercise Therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Jan 2019to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Ghent University, Department of Rehabilitation Sciences
Ghent, 9000
About this study
Official title: The FiREwORK Trial - Self-management With FootweaR Combined With Exercise for OsteoaRthritis (OA) at the Knee: a Phase II Randomized Controlled Trial
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.
Read more
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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Flat Flexible Shoes, Stable Supportive Shoes, Exercise Therapy
- Keywords
- Knee Osteoarthritis, Exercise Therapy, Shoes, Pain
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flat Flexible ShoesDevice
Off-the-shelf commercially available shoes will be used compliant with previously published criteria: (i) heel height <15 mm, (ii) shoe pitch <10 mm, (iii) absent arch support/motion control, (iv) minimal sole rigidity, (v) weight <=200g (+/-10%). Participants will be instructed to wear the shoes at least 4 hours daily for the duration of the 9-month intervention and to avoid wearing other types of shoes, if possible.
Stable Supportive ShoesDevice
Off-the-shelf commercially available shoes will be used compliant with previously published criteria: (i) heel height >30 mm, (ii) shoe pitch >10 mm, (iii) present arch support/motion control, (iv) sole rigidity, (v) weight >300g (+/-10%). Participants will be instructed to wear the shoes at least 4 hours daily for the duration of the 9-month intervention and to avoid wearing other types of shoes, if possible.
Exercise TherapyOther
The 3-month supervised exercise program will consist of one group session per week of approximately 30 minutes complemented with home-based exercises 3 times per week. Group sessions will consist of a 10-min warm-up followed by a circuit training of strengthening and/or neuromuscular exercises. Subsequently, during a 6-month unsupervised home exercise program, participants will perform strengthening exercises of the lower limb muscles 3 times weekly. Throughout the 9-month intervention, participants will be encouraged to maintain a daily routine of aerobic exercises, consisting of structured activity bouts of at least 10 minutes at a moderate intensity (grade 5-6 (out of 10, maximum exertion) on a Rate of Perceived Exertion scale), achieving at least 70 minutes of weekly physical activity at 3 months and 150 minutes at 9 months.
| Study group | Role | What they receive |
|---|---|---|
| Flat Flexible Shoes+Exercise Therapy | Experimental | 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). Receives: Device: Flat Flexible Shoes; Other: Exercise Therapy |
| Stable Supportive Shoes+Exercise Therapy | Active comparator | 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). Receives: Device: Stable Supportive Shoes; Other: Exercise Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in severity of knee pain on walking
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".
Measured: Measured at baseline, 13 and 37 weeks
Secondary outcomes (11)
Severity of intercondylar synovitis
Graded using the MRI Osteoarthritis Knee Score hoffa-synovitis sub-score, ranging grade 0 (normal) to grade 3 (severe).
Measured: Measured at baseline, 13 and 37 weeks
Severity of whole knee effusion
Graded using the MRI Osteoarthritis Knee Score effusion-synovitis sub-score, ranging grade 0 (physiologic amount) to grade 3 (large - evidence of capsular distention).
Measured: Measured at baseline, 13 and 37 weeks
Severity of bone marrow lesions
Graded using the MRI Osteoarthritis Knee Score bone marrow lesion sub-score, grade 0 (none) to grade 3 (>66% of subregional volume).
Measured: Measured at baseline, 13 and 37 weeks
Severity of physical dysfunction
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".
Measured: Measured at baseline, 13 and 37 weeks
Severity of knee pain overall
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".
Measured: Measured at baseline, 13 and 37 weeks
Participant-perceived global change in pain
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".
Measured: Measured at 13 and 37 weeks
Participant-perceived global change in physical function
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".
Measured: Measured at 13 and 37 weeks
Participant-perceived global change overall
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".
Measured: Measured at 13 and 37 weeks
Average Daily Step Count
Measured using a pedometer attached to the hip for 7 subsequent days to assess objective physical activity.
Measured: Measured during weeks 1, 12 and 36
Habitual physical activity level
Measured using the Physical Activity Scale for the Elderly with scores ranging 0-400 where higher scores indicate greater physical activity.
Measured: Measured at baseline, 13 and 37 weeks
Health-related quality of life
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).
Measured: Measured at baseline, 13 and 37 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start28 Jan 2019
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Universiteit Antwerpen
- Responsible party
- Sponsor
- Investigators
- Patrick Calders, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796832
- Sponsor's protocol ID
- B670201835057
- Other IDs
- G013318N, U1111-1225-9954
- Acronym
- FiREwORK
- Status last verified
- Oct 2023
- First submitted
- 21 Dec 2018
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dainese P, Stautemas J, De Mits S, Wittoek R, Van Ginckel A, Huysse W, Demeyer H, Mahieu H, Calders P. Exercise and footwear in medial knee osteoarthritis: a randomized controlled trial comparing flat flexible footwear to stable supportive shoes. Rheumatol Adv Pract. 2024 Oct 30;8(4):rkae133. doi: 10.1093/rap/rkae133. eCollection 2024.
PubMed 39669115
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The FiREwORK Trial - Self-management With FootweaR Combined With Exercise for OsteoaRthritis (OA) at the Knee: a Phase II Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03796832
- Acronym / sponsor ID
- FiREwORK / B670201835057
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, Exercise Therapy, Shoes, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Universiteit Antwerpen
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 8 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Flat Flexible Shoes+Exercise Therapy | Experimental | Device: Flat Flexible Shoes, Other: Exercise TherapyThis 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 | Active comparator | Device: Stable Supportive Shoes, Other: Exercise TherapyThis 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). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flat Flexible ShoesOff-the-shelf commercially available shoes will be used compliant with previously published criteria: (i) heel height <15 mm, (ii) shoe pitch <10 mm, (iii) absent arch support/motion control, (iv) minimal sole rigidity, (v) weight <=200g (+/-10%). Participants will be instructed to wear the shoes at least 4 hours daily for the duration of the 9-month intervention and to avoid wearing other types of shoes, if possible. | Device | Flat Flexible Shoes+Exercise Therapy |
| Stable Supportive ShoesOff-the-shelf commercially available shoes will be used compliant with previously published criteria: (i) heel height >30 mm, (ii) shoe pitch >10 mm, (iii) present arch support/motion control, (iv) sole rigidity, (v) weight >300g (+/-10%). Participants will be instructed to wear the shoes at least 4 hours daily for the duration of the 9-month intervention and to avoid wearing other types of shoes, if possible. | Device | Stable Supportive Shoes+Exercise Therapy |
| Exercise TherapyThe 3-month supervised exercise program will consist of one group session per week of approximately 30 minutes complemented with home-based exercises 3 times per week. Group sessions will consist of a 10-min warm-up followed by a circuit training of strengthening and/or neuromuscular exercises. Subsequently, during a 6-month unsupervised home exercise program, participants will perform strengthening exercises of the lower limb muscles 3 times weekly. Throughout the 9-month intervention, participants will be encouraged to maintain a daily routine of aerobic exercises, consisting of structured activity bouts of at least 10 minutes at a moderate intensity (grade 5-6 (out of 10, maximum exertion) on a Rate of Perceived Exertion scale), achieving at least 70 minutes of weekly physical activity at 3 months and 150 minutes at 9 months. | Other | Flat Flexible Shoes+Exercise Therapy, Stable Supportive Shoes+Exercise Therapy |
Primary outcome
Change in severity of knee pain on walking
Time frame: 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".
11 secondary outcomes
Severity of intercondylar synovitis
Time frame: Measured at baseline, 13 and 37 weeks
Severity of whole knee effusion
Time frame: Measured at baseline, 13 and 37 weeks
Severity of bone marrow lesions
Time frame: Measured at baseline, 13 and 37 weeks
Severity of physical dysfunction
Time frame: Measured at baseline, 13 and 37 weeks
Severity of knee pain overall
Time frame: Measured at baseline, 13 and 37 weeks
Participant-perceived global change in pain
Time frame: Measured at 13 and 37 weeks
Participant-perceived global change in physical function
Time frame: Measured at 13 and 37 weeks
Participant-perceived global change overall
Time frame: Measured at 13 and 37 weeks
Average Daily Step Count
Time frame: Measured during weeks 1, 12 and 36
Habitual physical activity level
Time frame: Measured at baseline, 13 and 37 weeks
Health-related quality of life
Time frame: Measured at baseline, 13 and 37 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 39669115Dainese P, Stautemas J, De Mits S, Wittoek R, Van Ginckel A, Huysse W, Demeyer H, Mahieu H, Calders P. Exercise and footwear in medial knee osteoarthritis: a randomized controlled trial comparing flat flexible footwear to stable supportive shoes. Rheumatol Adv Pract. 2024 Oct 30;8(4):rkae133. doi: 10.1093/rap/rkae133. eCollection 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Calders, PhD principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flat Flexible Shoes, Stable Supportive Shoes and Exercise Therapy in people with Knee Osteoarthritis, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in severity of knee pain on walking (time frame: Measured at baseline, 13 and 37 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03796832, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.