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

NCT06350435 | Completed DMC

• 1 other identifier: CUHK 2023.569
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Metatarsalgia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Foot and Ankle Outcome Score (FAOS)

  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

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

Study Arms (2)

Experimental Group

EXPERIMENTAL

Device: Prefabricated foot orthoses (PFO) with metatarsal pads

Control group

OTHER

Device: Prefabricated foot orthoses (PFO) without metatarsal pads

Interventions

Prefabricated foot orthoses (PFO) with metatarsal pads DEVICE

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

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

Experimental Group

Prefabricated foot orthoses (PFO) without metatarsal pads DEVICE

A pair of prefabricated foot orthoses only

Also known as: Slimflex® Amber Insoles

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Pamela Youde Nethersole Eastern Hospital: collaborator

Study Sites (1)

Pamela Youde Nethersole Eastern Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Metatarsalgia

Condition Hierarchy (Ancestors)

Foot Diseases; Musculoskeletal Diseases; Joint Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fung Ting Chan

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 5, 2024
• Study Start: January 26, 2024
• Primary Completion: April 18, 2024
• Study Completion: April 18, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)