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NCT07103070 · ClinicalTrials.gov registry record
A Test of Efficacy and Foot Position Alteration in Patients Wearing Good Feet Arch Supports for the Treatment of Pain
A clinical trial, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- 43
- Enrollment target
NCT07103070: Completed study, sponsored by Massachusetts General Hospital.
NCT07103070 is a clinical trial that has completed, run by Massachusetts General Hospital. The registered enrollment target is 43 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07103070 has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- 43 participants
- Enrollment target
Study Summary
This study is a single armed prospective case series designed to evaluate the efficacy of treating common structural-related foot ailments (i.e. plantar fasciitis, metatarsalgia, and/or hallux valgus) with a high quality non-custom made arch support. It is believed that these conditions are the result of inadequate or poorly fitted arch supports resulting in a lack of structural correction in the foot while weight bearing. Over-the-counter insoles are believed to counteract the shortcomings in foot structure that result in these painful conditions. In this study, it is proposed that changes in foot morphology can be measured quantitatively using weight bearing CT Scan (Computerized Tomography) and X-rays of the subject with and without the arch supports. Subjects will also answer questions from a validated series of questionnaires pertaining to their foot condition and generalized health and activity level. The study is a minimal risk study, with all subjects receiving the arch supports being investigated. There is no placebo offered. Initial evaluation of all subjects will include all imaging and measurements. Collection of subjective responses will occur after 4 weeks, 8 weeks, and 12 weeks of treatment.
Primary Outcome
Change in symptoms and relief of pain will be quantified based on subjective completion of validated questionnaires. Scoring is based on a 5-point scale, with higher scores indicating greater pain intensity. Raw scores are converted to T-scores, standardized to a mean of 50 (average for the general population) and a standard deviation of 10. Higher T-scores reflect more severe pain intensity.
Interventions
- DEVICE Arch supports
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2022-06-13 |
| Est. Completion | 2024-03-31 |
What the finished NCT07103070 record still lists
NCT07103070 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 43 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Arch supports is the first listed.
NCT07103070 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07103070 about?
NCT07103070 is a clinical study titled "A Test of Efficacy and Foot Position Alteration in Patients Wearing Good Feet Arch Supports for the Treatment of Pain". This study is a single armed prospective case series designed to evaluate the efficacy of treating common structural-related foot ailments (i.e. plantar fasciitis, metatarsalgia, and/or hallux valgus) with a high quality non-custom made arch support. It is believed that these conditions are the resu...
What is the current status of trial NCT07103070?
This trial is currently completed. The enrollment target is 43 participants. The study started on 2022-06-13. Estimated completion is 2024-03-31.
What interventions are being tested in trial NCT07103070?
The interventions under investigation include: Arch supports (DEVICE).
Who is sponsoring clinical trial NCT07103070?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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