An interventional study of Prefabricated foot orthoses (PFO) with metatarsal pads and Prefabricated foot orthoses (PFO) without metatarsal pads in Metatarsalgia, sponsored by Chinese University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-16.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment
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.
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.
Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.
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Exclusion Criteria:
Device: Prefabricated foot orthoses (PFO) with metatarsal pads
Device: Prefabricated foot orthoses (PFO) without metatarsal pads
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
A pair of prefabricated foot orthoses only
Also known as: Slimflex® Amber Insoles
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".
Time frame: 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.
Time frame: 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
Time frame: Baseline, a follow-up at 4-8 weeks from baseline
Plan to share: No
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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Metatarsalgia
Chinese University of Hong Kong