MetatarsalgiaNCT06350435
Effects of Prefabricated Foot Orthoses With and Without Metatarsal Pads on Central Metatarsalgia
A study testing Prefabricated foot orthoses (PFO) with metatarsal pads and Prefabricated foot orthoses (PFO) without metatarsal pads in people with Metatarsalgia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Compare the effects of prefabricated foot orthoses with and without metatarsal pads on pain intensity in the 2nd to 4th metatarsophalangeal joints, foot and ankle functional abilities as well as the occurrence of plantar callosities among patients with central metatarsalgia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metatarsalgia
- What is being tested?
- Prefabricated foot orthoses (PFO) with metatarsal pads and Prefabricated foot orthoses (PFO) without metatarsal pads
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteHong Kong
- Study dates
- 26 Jan 2024to 18 Apr 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years;
- Complain of foot pain on the 2nd to 4th MTPJs during walking in shoes, rating the pain intensity as ≥ 50mm on the Visual Analogue Scale (VAS);
- Able to be ambulant
Who cannot join
- Peripheral vascular disease (PVD)
- Neurological dysfunctions or neuromuscular disorders
- Active infection, i.e., cellulitis, osteomyelitis, shingles
- Cognitive impairment
- History of lower limb surgery and currently undergoing rehabilitation
- Active ulceration on foot and ankle
- Current utilization of prescribed insoles
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Prefabricated Foot Orthoses With and Without Metatarsal Pads in People With Central Metatarsalgia: A Randomized Controlled Trial
Compare the effects of prefabricated foot orthoses with and without metatarsal pads on pain intensity in the 2nd to 4th metatarsophalangeal joints, foot and ankle functional abilities as well as the occurrence of plantar callosities among patients with central metatarsalgia.
Read the detailed description
Metatarsalgia is a common condition that affecting about 10% of the general population. Central metatarsalgia involves pathology of the 2nd to 4th metatarsal and their respective metatarsophalangeal joints. This randomized control trial is designed to compare the effects of prefabricated foot orthoses with and without metatarsal pads on pain intensity, foot and ankle functional abilities as well as the occurrence of plantar callosities.
- Conditions
- Metatarsalgia
- Being tested
- Prefabricated foot orthoses (PFO) with metatarsal pads, Prefabricated foot orthoses (PFO) without metatarsal pads
- Medical subject headings
- Metatarsalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prefabricated foot orthoses (PFO) with metatarsal padsDevice
Also called Slimflex® Amber Insoles, Podotech® High Density Metatarsal Pad- Wide Raise SD2121, SD2122, SD2123
A pair of prefabricated foot orthoses, each with a metatarsal pad to be affixed underneath
Prefabricated foot orthoses (PFO) without metatarsal padsDevice
Also called Slimflex® Amber Insoles
A pair of prefabricated foot orthoses only
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Not described Receives: Device: Prefabricated foot orthoses (PFO) with metatarsal pads |
| Control group | Other | Not described Receives: Device: Prefabricated foot orthoses (PFO) without metatarsal pads |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity at the 2nd to 4th metatarsophalangeal joints during walking in shoes on Visual Analogue Scale
VAS consists of a 100mm-long uninterrupted horizontal line, with 2 verbal description at each end. A score of 0mm represents "no pain" while 100 mm represents "the worst imaginable pain".
Measured: Baseline, a follow-up at 4-8 weeks from baseline
Secondary outcomes (2)
Foot and Ankle Outcome Score (FAOS)
FAOS consists of 42 questions, which are categorized into 5 subdomains: symptoms, pain, activities of daily living, sports and quality of life. Each question id rated on a 5-point Likert scale, ranging from 0 to 4 and subsequently transformed into a normalized score between 0 and 100. A score of 100 indicates absence of symptoms, while a score of 0 indicates the presence of severe symptoms.
Measured: Baseline, a follow-up at 4-8 weeks from baseline
Size of callosities and corns on the plantar area of the 2nd to 4th metatarsophalangeal joints
Measured: Baseline, a follow-up at 4-8 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start26 Jan 2024
- Primary completion18 Apr 2024
- Study completion18 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetatarsalgiaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Pamela Youde Nethersole Eastern Hospital
- Responsible party
- Principal investigator, Chan Fung Ting, Chinese University of Hong Kong
- Investigators
- Fung Ting Chan, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350435
- Sponsor's protocol ID
- CUHK 2023.569
- Status last verified
- Jul 2024
- First submitted
- 1 Apr 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Prefabricated Foot Orthoses With and Without Metatarsal Pads in People With Central Metatarsalgia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06350435
- Acronym / sponsor ID
- CUHK 2023.569
- Conditions
- Metatarsalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Pamela Youde Nethersole Eastern Hospital
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 18 Apr 2024 (actual)
- Study completion
- 18 Apr 2024 (actual)
- First posted
- 5 Apr 2024 (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.
Compare the effects of prefabricated foot orthoses with and without metatarsal pads on pain intensity in the 2nd to 4th metatarsophalangeal joints, foot and ankle functional abilities as well as the occurrence of plantar callosities among patients with central metatarsalgia.
Detailed description
Metatarsalgia is a common condition that affecting about 10% of the general population. Central metatarsalgia involves pathology of the 2nd to 4th metatarsal and their respective metatarsophalangeal joints. This randomized control trial is designed to compare the effects of prefabricated foot orthoses with and without metatarsal pads on pain intensity, foot and ankle functional abilities as well as the occurrence of plantar callosities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: Prefabricated foot orthoses (PFO) with metatarsal pads |
| Control group | Other | Device: Prefabricated foot orthoses (PFO) without metatarsal pads |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years;
- Complain of foot pain on the 2nd to 4th MTPJs during walking in shoes, rating the pain intensity as ≥ 50mm on the Visual Analogue Scale (VAS);
- Able to be ambulant
Key exclusion criteria (7 listed)
- Peripheral vascular disease (PVD)
- Neurological dysfunctions or neuromuscular disorders
- Active infection, i.e., cellulitis, osteomyelitis, shingles
- Cognitive impairment
- History of lower limb surgery and currently undergoing rehabilitation
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 |
|---|---|---|
| Prefabricated foot orthoses (PFO) with metatarsal padsAlso: Slimflex® Amber Insoles, Podotech® High Density Metatarsal Pad- Wide Raise SD2121, SD2122, SD2123A pair of prefabricated foot orthoses, each with a metatarsal pad to be affixed underneath | Device | Experimental Group |
| Prefabricated foot orthoses (PFO) without metatarsal padsAlso: Slimflex® Amber InsolesA pair of prefabricated foot orthoses only | Device | Control group |
Primary outcome
Pain intensity at the 2nd to 4th metatarsophalangeal joints during walking in shoes on Visual Analogue Scale
Time frame: Baseline, a follow-up at 4-8 weeks from baseline
VAS consists of a 100mm-long uninterrupted horizontal line, with 2 verbal description at each end. A score of 0mm represents "no pain" while 100 mm represents "the worst imaginable pain".
2 secondary outcomes
Foot and Ankle Outcome Score (FAOS)
Time frame: Baseline, a follow-up at 4-8 weeks from baseline
Size of callosities and corns on the plantar area of the 2nd to 4th metatarsophalangeal joints
Time frame: Baseline, a follow-up at 4-8 weeks from baseline
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 16 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Metatarsalgia
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Randomized Controlled Trial of Custom Foot Orthoses for Chronic Forefoot Pain
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US and MRI of the Forefoot: Intermetatarsal Bursitis or Morton's Neuroma
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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.
Fung Ting Chan principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prefabricated foot orthoses (PFO) with metatarsal pads and Prefabricated foot orthoses (PFO) without metatarsal pads in people with Metatarsalgia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 3 inclusion and 7 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 16 Jul 2024. 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 Hong Kong. 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?
Pain intensity at the 2nd to 4th metatarsophalangeal joints during walking in shoes on Visual Analogue Scale (time frame: Baseline, a follow-up at 4-8 weeks from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2024; AzTrials last refreshed its copy on 8 Nov 2026.