Metatarsalgia
Conditions
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.
Detailed 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.
Interventions
DEVICEPrefabricated foot orthoses (PFO) with metatarsal pads
A pair of prefabricated foot orthoses, each with a metatarsal pad to be affixed underneath
DEVICEPrefabricated foot orthoses (PFO) without metatarsal pads
A pair of prefabricated foot orthoses only
Sponsors
Pamela Youde Nethersole Eastern Hospital
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Foot and Ankle Outcome Score (FAOS) | 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. |
| 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 | — |
Countries
Hong Kong
Outcome results
None listed