The improvement effect of custom 3D printed foot orthoses on foot pain and foot function Musculoskeletal Diseases
Conditions
Interventions
A pre- and post-control study using Custom 3D printed foot orthoses
The study involves the use of custom 3D-printed foot orthoses tailored through 3D scanning technology, with participants from the ge
Sponsors
First People's Hospital of Kunshan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age under 75 years, able to cooperate with the use of orthotic insoles independently 2. No medication treatment within the past three months 3. No other foot issues, such as skin ulcerations or diabetic foot 4. Participants agree to have no plans for pregnancy from the time of signing the informed consent until the end of the trial 5. Participants fully understand the purpose, nature, methods, and potential adverse reactions of the study, voluntarily consent to participate and sign the informed consent form before the initiation of any research procedures
Exclusion criteria
Exclusion criteria: 1. Individuals who use any medications or medical devices outside of the study-required trial products during the study period 2. Those with cognitive impairments who are unable to comply with treatment 3. Participants who have received topical treatments, physical therapy, or rehabilitation for foot conditions within one month prior to screening, or who are undergoing other treatments that may affect efficacy 4. Individuals with a history of foot surgery within the past 12 months or those planning surgery on the affected area during the trial 5. Participants who used anesthetics, opioid analgesics, antispasmodics, long-acting non-steroidal anti-inflammatory drugs (e.g., piroxicam, meloxicam, naproxen, etoricoxib) or other medications that could influence efficacy assessment within the last 7 days prior to screening; those who use analgesics during the 3-month trial period will be considered to have withdrawn voluntarily 6. Foot and ankle pain due to neurological disorders, autoimmune diseases, foot trauma, or referred pain unrelated to structural abnormalities 7. Individuals with severe organic primary diseases affecting the cardiovascular, hepatic, renal, or hematological systems, as well as those with mental illnesses 8. Other reasons deemed inappropriate for enrollment by the researchers or participants who withdraw from the trial for personal reasons 9. During the follow-up period, the worker was unable to complete the follow-up due to various reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physical function measured Foot and Ankle Ability Measure (FAAM) at baseline and three months after using Custom 3D printed foot orthoses | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
China
Contacts
Public ContactChong Li
Outcome results
None listed