MetatarsalgiaNCT06962475
Randomized Controlled Trial of Custom Foot Orthoses for Chronic Forefoot Pain
A study testing Podiatric advice and Customized foot orthoses in people with Metatarsalgia, run by Université du Québec à Trois-Rivières at 1 site in Canada.
Trial summary
Background Chronic metatarsalgia (CM) causes significant pain and disability, affecting quality of life. Foot orthoses (FOs) including medially wedged designs with a metatarsal pad decrease excessive plantar pressure under the metatarsal heads, which is a suggested risk factor for developing CM. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metatarsalgia
- What is being tested?
- Podiatric advice and Customized foot orthoses
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2025to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- are aged 18 years or over,
- have bilateral or unilateral metatarsalgia under one or more of the lesser metatarsal heads for at least 3 months (pain score of ≥ 4 out of 10 on a Visual Analogue Scale (VAS)) that is aggravated by weight-bearing activities,
- are able to walk without assistive devices (e.g., cane, walker),
- are willing to wear shoes that will accommodate their FOs on a daily basis and
- are willing to minimize the use of other interventions (e.g., pain medications, physical therapy) during the trial period
Who cannot join
- have arthritis,
- have neurological diseases (e.g., intermetatarsal neuroma) or other mechanical pain, plantar corns (e.g., intractable plantar keratoma),
- have a history of orthopedic foot surgery,
- have prior use of customized FOs,
- have cognitive impairments,
- are pregnant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Université du Québec à Trois-Rivières
Trois-Rivières, Quebec, G9A 5H7
Eléna Payen Schalkens, 873 887 9707, elena.payen.schalkens@uqtr.ca
About this study
Official title: A Participant- and Assessor-blinded Superiority Randomized Controlled Trial of Custom Foot Orthoses for Chronic Metatarsalgia
Background Chronic metatarsalgia (CM) causes significant pain and disability, affecting quality of life. Foot orthoses (FOs) including medially wedged designs with a metatarsal pad decrease excessive plantar pressure under the metatarsal heads, which is a suggested risk factor for developing CM. This FOs model may be effective in diminishing pain and improving function in these individuals. Thus, the objective of this trial will be to compare the effects of medially wedged FOs with a metatarsal pad and sham FOs on pain and foot function in individuals with CM.
Methods/design This participant- and assessor-blinded superiority randomized controlled trial (RCT) with two parallel groups will be conducted in Trois-Rivières, Canada. Sixty-four participants with CM will be recruited from the Université du Québec à Trois-Rivières outpatient podiatry clinic and via social media invitations. They will be randomized into intervention (customized FOs) or control (sham FOs) groups and will be evaluated at baseline and after 6 and 12 weeks. The primary outcome will be: (1) mean pain during walking for the most painful foot during the past week. The secondary outcomes will be: (1) Foot Function Index, (2) Global rating of change and (3) the 5-level EQ-5D.
Discussion Medially wedged FOs with a metatarsal pad are expected to provide a greater reduction in pain and improvement in foot function compared to sham FOs. This trial will help guide FOs prescription recommendations for managing foot pain in individuals with CM in the future.
Read the detailed description
Foot musculoskeletal disorders cause significant impairments and disabilities for those affected. Among the various types of foot pain, chronic metatarsalgia (CM) is the most prevalent. Metatarsalgia represents 88% of all causes of foot pain, with a prevalence of 13 to 36% in adults. It is characterized by persistent pain to one or more metatarsophalangeal joints, resulting from harm (whether of mechanical origin or not) to the anatomical structures associated with the joint, including bone, cartilage, capsule and ligaments, tendons, bursae and subcutaneous tissue, and skin. Chronic metatarsalgia significantly reduces the quality of life of those affected, physically, psychologically, and socially. Different treatment modalities are used for CM, such as stretching exercises, footwear modifications, and foot orthoses (FOs). The first-line treatment is conservative, and surgery should be considered only when conservative treatment fails. Nevertheless, there is little high-level evidence (level I) to support the efficacy of conservative treatments for CM.
The reduction of the mechanical overload under the metatarsal heads during locomotion is a fundamental aspect of CM treatment, and it strongly correlates with pain reduction. Foot orthoses are commonly used devices to reduce pain and improve function in individuals with musculoskeletal disorders. They reduce forefoot plantar pressure during locomotion in individuals with CM and redistribute plantar pressure more evenly. Metatarsal pads, a common FOs modification, effectively redistribute forefoot plantar pressure and thus reduce pain caused by excessive metatarsal loads. Adding a medial wedge to FOs (inclination in the frontal plane) further reduces forefoot peak pressure in healthy adults. While FOs tested so far are generally effective in managing CM, their effects can be inconsistent across patients, some patients did not find them effective. From a biomechanical standpoint, FOs reduce mechanical overload; however, it is crucial to determine whether they also effectively reduce pain and improve foot function. Randomized controlled trials (RCT) are considered the gold standard for evaluating treatment effectiveness and efficiently translating research findings into clinical practice. This study design will allow us to assess whether, in addition to their biomechanical effects, FOs provide clinical benefits for individuals with CM.
All details are here : https://doi.org/10.1371/journal.pone.0340905
- Conditions
- Metatarsalgia
- Being tested
- Podiatric advice, Customized foot orthoses, Sham foot orthoses
- Keywords
- RCT, Metatarsalgia, Foot Orthoses, Sham, Customized
- Medical subject headings
- Metatarsalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Podiatric adviceOther
A podiatrist with 11 years of clinical experience will take the negative foot impressions using a semi-weightbearing method with a foam box for both groups to ensure adequate blinding of participants. Then, the foam boxes of the experimental group will be scanned so that the FOs can be 3D printed. Both groups will receive identical clinical guideline-based information and support at the beginning of the trial. The instructions will be as follows: (1) undertake a familiarization protocol of 14 consecutive full days (2) wear the FOs (customized or sham) at all time when they are standing (targeted minimum of 5 hours per day), (3) avoid positions that cause the metatarsophalangeal joints to dorsiflex (e.g., squatting or tiptoeing), (4) mechanical stress load management according to the tissue stress model, (5) do not walk barefoot and (6) wear shoes with good cushioning in which the FOs will be properly placed.
Customized foot orthosesOther
The customized foot orthoses will be manufactured with a Nylon-11 shell with 6° medially wedged forefoot-rearfoot posts (2.6 mm if the participants' weight (PW) is inferior or equal to 45 kg; 3.2 mm if 45<PW<100 kg; 4.0 mm if PW>100 kg), a full-length 3 mm Poron top cover and a metatarsal pad (15 shore A) located 5 mm proximal to the metatarsal heads.
Sham foot orthosesOther
The molded sham FOs will be manufactured from 3 mm ethylene vinyl acetate. They will have an identical top cover material, color and a similar shape than the customized FOs, however, they will provide negligible mechanical support, considering the very low stiffness of their medial arch. The only impact of these FOs on plantar pressure is under the heel. These devices have been used as a sham condition in previous trials and a study has validated them as being credible.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants randomized to the intervention group will receive customized FOs for both feet. Receives: Other: Podiatric advice; Other: Customized foot orthoses |
| Control group | Sham comparator | Participants randomized to the control group will receive sham FOs for both feet. Receives: Other: Podiatric advice; Other: Sham foot orthoses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean pain during walking for the most painful foot during the past week
visual analog scale (from 0 to 10, 0 being no pain and 10 pain as bad as it could be).
Measured: From Baseline to the end of follow-up at 12 weeks
Secondary outcomes (3)
Foot Function Index (FFI)
The FFI is a widely used, valid, and reliable self-administered questionnaire consisting of 23 items grouped into 3 domains: foot pain (9 items), disability (9 items), and activity limitation (5 items) : we used disability (min: 0, max: 90) and activity limitation (min: 0, max: 50) subscales.
Measured: From Baseline to the end of follow-up at 12 weeks
Global rating of change (GROC)
participants' perception of overall treatment effect will be measured using the self-reported global rating of change scale [33]. This outcome will then be dichotomized into the categories of "effective" ("a very great deal better", "a great deal better", "a good deal better" and "moderately better") and "ineffective" ("somewhat better", "a little better", "about the same, hardly any better at all", "no change", "about the same, hardly any worse at all", "a little worse", "somewhat worse", "moderately worse", "a good deal worse", "a great deal worse" and 'a very great deal worse")
Measured: During the follow-up: 6weeks and 12 weeks
Health-related quality of life (HRQoL)
the 5-level EQ-5D (EQ-5D-5L) will be used [35]. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The participant will be asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Measured: From Baseline to the end of follow-up at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start1 Feb 2025
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
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 MetatarsalgiaStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université du Québec à Trois-Rivières
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962475
- Sponsor's protocol ID
- 2025_UQTR_FOs_RCT
- Status last verified
- Feb 2026
- First submitted
- 29 Jan 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Payen Schalkens E, Acien M, Marchand AA, Isabelle PL, Abboud J, Moisan G. Custom foot orthoses for chronic metatarsalgia: Study protocol for a participant- and assessor-blinded superiority randomized controlled trial. PLoS One. 2026 Jan 16;21(1):e0340905. doi: 10.1371/journal.pone.0340905. eCollection 2026.
PubMed 41544006
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Participant- and Assessor-blinded Superiority Randomized Controlled Trial of Custom Foot Orthoses for Chronic Metatarsalgia
- ClinicalTrials.gov ID
- NCT06962475
- Acronym / sponsor ID
- 2025_UQTR_FOs_RCT
- Conditions
- Metatarsalgia
- Keywords
- RCT, Metatarsalgia, Foot Orthoses, Sham, Customized
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Université du Québec à Trois-RivièresUniversity, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 8 May 2025 (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.
Background Chronic metatarsalgia (CM) causes significant pain and disability, affecting quality of life. Foot orthoses (FOs) including medially wedged designs with a metatarsal pad decrease excessive plantar pressure under the metatarsal heads, which is a suggested risk factor for developing CM. This FOs model may be effective in diminishing pain and improving function in these individuals. Thus, the objective of this trial will be to compare the effects of medially wedged FOs with a metatarsal pad and sham FOs on pain and foot function in individuals with CM.
Methods/design This participant- and assessor-blinded superiority randomized controlled trial (RCT) with two parallel groups will be conducted in Trois-Rivières, Canada. Sixty-four participants with CM will be recruited from the Université du Québec à Trois-Rivières outpatient podiatry clinic and via social media invitations. They will be randomized into intervention (customized FOs) or control (sham FOs) groups and will be evaluated at baseline and after 6 and 12 weeks. The primary outcome will be: (1) mean pain during walking for the most painful foot during the past week. The secondary outcomes will be: (1) Foot Function Index, (2) Global rating of change and (3) the 5-level EQ-5D.
Discussion Medially wedged FOs with a metatarsal pad are expected to provide a greater reduction in pain and improvement in foot function compared to sham FOs. This trial will help guide FOs prescription recommendations for managing foot pain in individuals with CM in the future.
Detailed description
Foot musculoskeletal disorders cause significant impairments and disabilities for those affected. Among the various types of foot pain, chronic metatarsalgia (CM) is the most prevalent. Metatarsalgia represents 88% of all causes of foot pain, with a prevalence of 13 to 36% in adults. It is characterized by persistent pain to one or more metatarsophalangeal joints, resulting from harm (whether of mechanical origin or not) to the anatomical structures associated with the joint, including bone, cartilage, capsule and ligaments, tendons, bursae and subcutaneous tissue, and skin. Chronic metatarsalgia significantly reduces the quality of life of those affected, physically, psychologically, and socially. Different treatment modalities are used for CM, such as stretching exercises, footwear modifications, and foot orthoses (FOs). The first-line treatment is conservative, and surgery should be considered only when conservative treatment fails. Nevertheless, there is little high-level evidence (level I) to support the efficacy of conservative treatments for CM.
The reduction of the mechanical overload under the metatarsal heads during locomotion is a fundamental aspect of CM treatment, and it strongly correlates with pain reduction. Foot orthoses are commonly used devices to reduce pain and improve function in individuals with musculoskeletal disorders. They reduce forefoot plantar pressure during locomotion in individuals with CM and redistribute plantar pressure more evenly. Metatarsal pads, a common FOs modification, effectively redistribute forefoot plantar pressure and thus reduce pain caused by excessive metatarsal loads. Adding a medial wedge to FOs (inclination in the frontal plane) further reduces forefoot peak pressure in healthy adults. While FOs tested so far are generally effective in managing CM, their effects can be inconsistent across patients, some patients did not find them effective. From a biomechanical standpoint, FOs reduce mechanical overload; however, it is crucial to determine whether they also effectively reduce pain and improve foot function. Randomized controlled trials (RCT) are considered the gold standard for evaluating treatment effectiveness and efficiently translating research findings into clinical practice. This study design will allow us to assess whether, in addition to their biomechanical effects, FOs provide clinical benefits for individuals with CM.
All details are here : https://doi.org/10.1371/journal.pone.0340905
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Podiatric advice, Other: Customized foot orthosesParticipants randomized to the intervention group will receive customized FOs for both feet. |
| Control group | Sham comparator | Other: Podiatric advice, Other: Sham foot orthosesParticipants randomized to the control group will receive sham FOs for both feet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- are aged 18 years or over,
- have bilateral or unilateral metatarsalgia under one or more of the lesser metatarsal heads for at least 3 months (pain score of ≥ 4 out of 10 on a Visual Analogue Scale (VAS)) that is aggravated by weight-bearing activities,
- are able to walk without assistive devices (e.g., cane, walker),
- are willing to wear shoes that will accommodate their FOs on a daily basis and
- are willing to minimize the use of other interventions (e.g., pain medications, physical therapy) during the trial period
Key exclusion criteria (6 listed)
- have arthritis,
- have neurological diseases (e.g., intermetatarsal neuroma) or other mechanical pain, plantar corns (e.g., intractable plantar keratoma),
- have a history of orthopedic foot surgery,
- have prior use of customized FOs,
- have cognitive impairments,
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 |
|---|---|---|
| Podiatric adviceA podiatrist with 11 years of clinical experience will take the negative foot impressions using a semi-weightbearing method with a foam box for both groups to ensure adequate blinding of participants. Then, the foam boxes of the experimental group will be scanned so that the FOs can be 3D printed. Both groups will receive identical clinical guideline-based information and support at the beginning of the trial. The instructions will be as follows: (1) undertake a familiarization protocol of 14 consecutive full days (2) wear the FOs (customized or sham) at all time when they are standing (targeted minimum of 5 hours per day), (3) avoid positions that cause the metatarsophalangeal joints to dorsiflex (e.g., squatting or tiptoeing), (4) mechanical stress load management according to the tissue stress model, (5) do not walk barefoot and (6) wear shoes with good cushioning in which the FOs will be properly placed. | Other | Control group, Intervention Group |
| Customized foot orthosesThe customized foot orthoses will be manufactured with a Nylon-11 shell with 6° medially wedged forefoot-rearfoot posts (2.6 mm if the participants' weight (PW) is inferior or equal to 45 kg; 3.2 mm if 45<PW<100 kg; 4.0 mm if PW>100 kg), a full-length 3 mm Poron top cover and a metatarsal pad (15 shore A) located 5 mm proximal to the metatarsal heads. | Other | Intervention Group |
| Sham foot orthosesThe molded sham FOs will be manufactured from 3 mm ethylene vinyl acetate. They will have an identical top cover material, color and a similar shape than the customized FOs, however, they will provide negligible mechanical support, considering the very low stiffness of their medial arch. The only impact of these FOs on plantar pressure is under the heel. These devices have been used as a sham condition in previous trials and a study has validated them as being credible. | Other | Control group |
Primary outcome
Mean pain during walking for the most painful foot during the past week
Time frame: From Baseline to the end of follow-up at 12 weeks
visual analog scale (from 0 to 10, 0 being no pain and 10 pain as bad as it could be).
3 secondary outcomes
Foot Function Index (FFI)
Time frame: From Baseline to the end of follow-up at 12 weeks
Global rating of change (GROC)
Time frame: During the follow-up: 6weeks and 12 weeks
Health-related quality of life (HRQoL)
Time frame: From Baseline to the end of follow-up at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Derived from this study: PubMed 41544006Payen Schalkens E, Acien M, Marchand AA, Isabelle PL, Abboud J, Moisan G. Custom foot orthoses for chronic metatarsalgia: Study protocol for a participant- and assessor-blinded superiority randomized controlled trial. PLoS One. 2026 Jan 16;21(1):e0340905. doi: 10.1371/journal.pone.0340905. eCollection 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Podiatric advice and Customized foot orthoses in people with Metatarsalgia, run by Université du Québec à Trois-Rivières at 1 site in Canada.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 10 Feb 2026. 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 Canada. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eléna Payen, Msc (873 887 9707, elena.payen@uqtr.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean pain during walking for the most painful foot during the past week (time frame: From Baseline to the end of follow-up at 12 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 NCT06962475, 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 10 Feb 2026.