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

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.

Study Overview

• Status: Completed
• Conditions: Metatarsalgia
• Intervention / Treatment: Device: Prefabricated foot orthoses (PFO) with metatarsal pads; Device: Prefabricated foot orthoses (PFO) without metatarsal pads

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Pamela Youde Nethersole Eastern Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group	Device: Prefabricated foot orthoses (PFO) with metatarsal pads; A pair of prefabricated foot orthoses, each with a metatarsal pad to be affixed underneath; Other Names: Slimflex® Amber Insoles; Podotech® High Density Metatarsal Pad- Wide Raise SD2121, SD2122, SD2123
Other: Control group	Device: Prefabricated foot orthoses (PFO) without metatarsal pads; A pair of prefabricated foot orthoses only; Other Names: Slimflex® Amber Insoles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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".	Baseline, a follow-up at 4-8 weeks from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.	Baseline, a follow-up at 4-8 weeks from baseline

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: Pamela Youde Nethersole Eastern Hospital
• Investigators: Principal Investigator: Fung Ting Chan, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2024
• Primary Completion (Actual): April 18, 2024
• Study Completion (Actual): April 18, 2024

Study Registration Dates

• First Submitted: April 1, 2024
• First Submitted That Met QC Criteria: April 1, 2024
• First Posted (Actual): April 5, 2024

Study Record Updates

• Last Update Posted (Actual): July 16, 2024
• Last Update Submitted That Met QC Criteria: July 15, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Foot Diseases; Joint Diseases; Musculoskeletal Diseases; Metatarsalgia
• Other Study ID Numbers: CUHK 2023.569

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No