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

Chinese University of Hong Kong32 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metatarsalgia

Interventions

Prefabricated foot orthoses (PFO) with metatarsal padsDEVICE

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

Prefabricated foot orthoses (PFO) without metatarsal padsDEVICE

A pair of prefabricated foot orthoses only

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pamela Youde Nethersole Eastern Hospital

Hong Kong, Hong Kong

Outcomes

Primary Outcomes

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".

Time frame: Baseline, a follow-up at 4-8 weeks from baseline

Secondary Outcomes

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.

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

Data from ClinicalTrials.gov

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