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

The Chinese University of Hong Kong logo

The Chinese University of Hong Kong

Status

Completed

Conditions

Metatarsalgia

Treatments

Device: Prefabricated foot orthoses (PFO) with metatarsal pads
Device: Prefabricated foot orthoses (PFO) without metatarsal pads

Study type

Interventional

Funder types

Other

Identifiers

NCT06350435
CUHK 2023.569

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

32 participants in 2 patient groups

Experimental Group
Experimental group
Treatment:
Device: Prefabricated foot orthoses (PFO) with metatarsal pads
Control group
Other group
Treatment:
Device: Prefabricated foot orthoses (PFO) without metatarsal pads

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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