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

Metatarsalgia Clinical Trial

Official title:

Effects of Prefabricated Foot Orthoses With and Without Metatarsal Pads in People With Central Metatarsalgia: A Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06350435
• Other study ID #: CUHK 2023.569
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 18, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: April 2024
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: May 31, 2024
• Est. primary completion date: April 26, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metatarsalgia

Intervention

Device:
• Prefabricated foot orthoses (PFO) with metatarsal pads
A pair of prefabricated foot orthoses, each with a metatarsal pad to be affixed underneath
• Prefabricated foot orthoses (PFO) without metatarsal pads
A pair of prefabricated foot orthoses only

Locations

Country	Name	City	State
Hong Kong	Pamela Youde Nethersole Eastern Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Pamela Youde Nethersole Eastern Hospital

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Foot and Ankle Outcome Score		Baseline, a follow-up at 4-8 weeks from baseline
Secondary	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