Effects of Prefabricated Foot Orthoses With and Without Metatarsal Pads on Central Metatarsalgia

NCT ID: NCT06350435

Last Updated: 2024-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-26

Study Completion Date

2024-04-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Metatarsalgia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental Group

Group Type EXPERIMENTAL

Prefabricated foot orthoses (PFO) with metatarsal pads

Intervention Type DEVICE

A pair of prefabricated foot orthoses, each with a metatarsal pad to be affixed underneath

Control group

Group Type OTHER

Prefabricated foot orthoses (PFO) without metatarsal pads

Intervention Type DEVICE

A pair of prefabricated foot orthoses only

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Prefabricated foot orthoses (PFO) with metatarsal pads

A pair of prefabricated foot orthoses, each with a metatarsal pad to be affixed underneath

Intervention Type DEVICE

Prefabricated foot orthoses (PFO) without metatarsal pads

A pair of prefabricated foot orthoses only

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Slimflex® Amber Insoles Podotech® High Density Metatarsal Pad- Wide Raise SD2121, SD2122, SD2123 Slimflex® Amber Insoles

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pamela Youde Nethersole Eastern Hospital

OTHER

Sponsor Role collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Chan Fung Ting

Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Fung Ting Chan

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pamela Youde Nethersole Eastern Hospital

Hong Kong, , Hong Kong

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Hong Kong

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CUHK 2023.569

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Orthotics, Pain & Fear of Falling
NCT04894396 COMPLETED NA