Effectiveness of custom 3D-printed foot orthoses in improving foot symptoms: a pre-and post-intervention study
| ISRCTN | ISRCTN77775253 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77775253 |
- Submission date
- 23/02/2025
- Registration date
- 13/03/2025
- Last edited
- 07/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
This study aims to evaluate the effectiveness of custom 3D-printed foot orthoses in improving foot symptoms and functional status by comparing baseline and post-intervention outcomes. Custom 3D-printed foot orthoses are expected to effectively improve functional status and alleviate foot symptoms, supporting their use as a personalized treatment option in clinical practice. Future research should investigate their long-term efficacy and adaptability across diverse populations.
Who can participate?
Participants aged from 18 to 75 years old with and without foot pain
What does the study involve?
Baseline data included demographic and clinical characteristics (e.g., age, sex), physical function questionnaire scores, and pain intensity assessed using the numeric rating scale (NRS), and 3D-scanned foot morphology data. After three months of using custom 3D-printed foot orthoses, follow-up questionnaire scores were collected for comparison.
What are the possible benefits and risks of participating?
Possible Benefits: The custom insoles are designed based on the user’s foot morphology, providing active support to redistribute foot pressure, alleviate fatigue, and reduce pain. They offer excellent support and cushioning, protecting the feet, ankles, and knees from sports-related injuries. The insoles can also correct biomechanical misalignment caused by conditions such as high arches, flat feet, or foot deformities, helping to distribute foot pressure, enhance balance, improve athletic performance, and prevent injuries. They are particularly beneficial for older adults, as they support the arch of the foot, alleviate joint degeneration and fatigue, and improve overall quality of life. Additionally, the insoles can slow down or prevent the progression of hallux valgus and related foot conditions, promoting foot health.
Possible Risks: There is a possibility that foot pain symptoms may not improve, and foot function may not be enhanced.
Where is the study run from?
Affiliated Kunshan Hospital of Jiangsu University, China
When is the study starting and how long is it expected to run for?
November 2023 to May 2024
Who is funding the study?
Medical Innovation (Suzhou) Clinical Research Co., Ltd
Who is the main contact?
Dr Chong Li, lichong1705@163.com
Contact information
Public, Scientific, Principal Investigator
The First People’s Hospital of Kunshan, No. 566 East of Qianjin Road
Suzhou, Jiangsu
215300
China
 ORCID ID |
0000-0002-1526-221X |
|---|---|
| Phone | +86-0512-57532362 |
| lichong1705@163.com |
Study information
| Study design | Single-group pre-and post-intervention study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Quality of life, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Effectiveness of custom 3D-printed foot orthoses in improving FAAM scores among general populations: a pre-and post-intervention study |
| Study objectives | Custom 3D-printed foot orthoses have a positive effect on foot pain and foot function |
| Ethics approval(s) |
Approved 05/07/2024, The First People’s Hospital of Kunshan (No. 566 East of Qianjin Road, Suzhou, Jiangsu, 215300, China; +86-0512-57029736; sgu8434@sina.com), ref: 2024-03-029-H01-Κ00 |
| Health condition(s) or problem(s) studied | The improvement effect of custom 3D printed foot orthoses on foot pain and foot function |
| Intervention | 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 general population using the orthoses for at least 24 days per month and 8 hours per day over a 3-month follow-up period. The intervention is location-independent, and data collection includes participant demographics, baseline and follow-up FAAM scores, baseline NRS scores, and 3D foot scan data. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Custom 3D printed foot orthoses |
| Primary outcome measure | Physical function measured Foot and Ankle Ability Measure (FAAM) at baseline and three months after using Custom 3D printed foot orthoses |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 03/11/2023 |
| Completion date | 07/05/2024 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 200 |
| Total final enrolment | 76 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 03/11/2023 |
| Date of final enrolment | 07/05/2024 |
Locations
Countries of recruitment
- China
Study participating centre
Suzhou, Jiangsu
215300
China
Sponsor information
Hospital/treatment centre
No. 566 East of Qianjin Road
Suzhou, Jiangsu
215300
China
| Phone | +86-0512- |
|---|---|
| not@available.com | |
| Website | https://www.ksrmyy.org/ |
"ROR" |
https://ror.org/01kzsq416 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 07/05/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the results publication |
Editorial Notes
25/02/2025: Study's existence confirmed by the Independent Ethics Committee at the First People’s Hospital of Kunshan. This study is a preliminary pilot trial conducted as part of a larger randomized controlled trial (RCT). As such, the data collection for this pilot phase commenced prior to the formal approval of the ethics documentation for the main study.
