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NCT Number: NCT06350435

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pamela Youde Nethersole Eastern Hospital

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prefabricated foot orthoses (PFO) with metatarsal pads

Device

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

Prefabricated foot orthoses (PFO) without metatarsal pads

Device

A pair of prefabricated foot orthoses only

Other names: Slimflex® Amber Insoles

Primary outcomes

  1. Pain intensity at the 2nd to 4th metatarsophalangeal joints during walking in shoes on Visual Analogue Scale

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

    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".

Secondary outcomes

  1. Foot and Ankle Outcome Score (FAOS)

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

    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.

  2. 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

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • Pamela Youde Nethersole Eastern Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 5, 2024
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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