Flat feet Musculoskeletal Diseases
Conditions
Interventions
The study employed a parallel-group randomization design with a 1:1 allocation ratio. The randomization sequence was generated by an independent statistics unit using SAS software (version 9.4, SAS In
Sponsors
First People's Hospital of Kunshan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18-65 years, male or female, capable of independent cooperation and orthotic insole usage. 2. Physician-confirmed diagnosis of flatfoot during screening. 3. No prior treatment received for the condition after symptom onset. 4. Absence of other foot disorders (e.g., foot ulcers, diabetic foot). 5. Agreement to avoid pregnancy from informed consent signing through trial completion. 6. Full understanding of trial objectives, procedures, and risks; voluntary participation with signed informed consent before any study procedures.
Exclusion criteria
Exclusion criteria: 1. Unauthorized use of non-protocol drugs/medical devices during the trial. 2. Cognitive impairment preventing treatment cooperation. 3. Flatfoot deemed by a physician to require surgical intervention (conservative treatment failure). 4. Foot-related topical agents, physical therapy, or rehabilitation within 1 month before screening, or concurrent treatments affecting efficacy. 5. History of foot surgery within 12 months before screening or planned surgery during the trial. 6. Use of anesthetics, opioids, antispasmodics, long-acting NSAIDs (e.g., piroxicam, meloxicam, nabumetone, etoricoxib), or other efficacy-impacting drugs within 7 days before screening. 7. Foot/ankle pain unrelated to structural abnormalities (e.g., neurological disorders, rheumatoid conditions, trauma, referred pain). 8. Severe primary diseases (cardiovascular, hepatic, renal, hematopoietic) or psychiatric disorders. 9. Other investigator-determined unsuitability or voluntary withdrawal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall foot function is measured using the Foot and Ankle Ability Measure (FAAM) score at baseline, 1, 2 and 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Daily activity functions are measured using the Foot and Ankle Ability Measure (FAAM) - Activities of Daily Living (ADL) score at baseline, 1, 2 and 3 months 2. Sports function is measured using the Foot and Ankle Ability Measure (FAAM) - Sports score at baseline, 1, 2 and 3 months 3. Pain is measured using the Numerical Rating Scale (NRS) for pain at baseline, 1, 2 and 3 months | — |
Countries
China
Contacts
Public ContactKe Lu
Outcome results
None listed