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

Not Applicable

Completed

• Conditions: Metatarsalgia
• Interventions: Device: Prefabricated foot orthoses (PFO) without metatarsal pads; Device: Prefabricated foot orthoses (PFO) with metatarsal pads

• Registration Number: NCT06350435
• Lead Sponsor: Chinese University of Hong Kong

Brief 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.

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 Timeline

• Study Start: 2024-01-26
• Study First Submitted: 2024-04-01
• Study First Submitted QC: 2024-04-01
• Study First Posted: 2024-04-05
• Primary Completion: 2024-04-18
• Study Completion: 2024-04-18
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Prefabricated foot orthoses (PFO) without metatarsal pads	-
Experimental Group	Prefabricated foot orthoses (PFO) with metatarsal pads	-

Primary Outcome Measures

Name	Time	Method
Pain intensity at the 2nd to 4th metatarsophalangeal joints during walking in shoes on Visual Analogue Scale	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".

Secondary Outcome Measures

Name	Time	Method
Foot and Ankle Outcome Score (FAOS)	Baseline, a follow-up at 4-8 weeks from baseline	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.
Size of callosities and corns on the plantar area of the 2nd to 4th metatarsophalangeal joints	Baseline, a follow-up at 4-8 weeks from baseline

Trial Locations

Locations (1)

Pamela Youde Nethersole Eastern Hospital; 🇭🇰 Hong Kong, Hong Kong