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NCT05763381 · ClinicalTrials.gov registry record · NA
Low-Level Laser Therapy for Plantar Fasciitis
A NA study, sponsored by The Geneva Foundation.
- Completed
- Registry status
- NA
- Development phase
- 71
- Enrollment target
NCT05763381: Completed NA study, sponsored by The Geneva Foundation.
NCT05763381 is a NA study that has completed, run by The Geneva Foundation. The registered enrollment target is 71 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05763381, a NA study, has completed, sponsored by The Geneva Foundation.
- COMPLETED
- Registry status
- NA
- Development phase
- 71 participants
- Enrollment target
Study Summary
Plantar fasciitis (PF), a degenerative injury of the connective tissue in the foot, results in pain-related disability in Service Members and contributes to decreased physical activity and excessive healthcare costs. Even if effective, current treatment protocols may require 6-12 months of therapy to return individuals to pain-free activity. Photobiomodulation therapy (PBMT) uses non-ionizing light to elicit biological changes in tissues resulting in beneficial therapeutic outcomes. Evidence supports use of PBM for other degenerative connective tissue conditions, such as achilles tendinopathy and epicondylitis. A previous pilot study was completed in an active-duty military and civilian population, which demonstrated a positive effect of two PBM dose parameters on function and pain levels in participants with chronic PF when combined with stretching and ice. These positive findings from the aforementioned study are promising in the treatment of this common and debilitating issue, but require the addition of a sham comparison to rigorously eliminate any potential placebo effect of the treatment protocol, and further refine the treatment protocol in order to make evidence-based clinical recommendations. As such, proposing a follow-up study and the addition of an objective outcome measure will strengthen the impact of the study. SPECIFIC AIM 1: To assess the clinical effectiveness of photobiomodulation compared to sham photobiomodulation to improve function and decrease pain. SPECIFIC AIM 2: To evaluate the effectiveness of photobiomodulation compared to sham photobiomodulation to resolve plantar fascial thickening. DESIGN: A prospective randomized sham-controlled trial to meet the aims of the study. METHOD: A sample of up to 100 active-duty military members will be randomly assigned to the Sham-PBMT or PBMT group. At baseline, during the treatment protocol, and at long-term (3 and 6 months) follow-up, measures of foot function, pain, and plantar fascial thickness w
Primary Outcome
The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included PF cases in development. There are two subscales, Activities of Daily Living(ADL) (21- item) and Sports (7-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). The minimum clinically important difference 8 \& 9 points for ADL \& Sports subscale, respectively. Higher s
Interventions
- DEVICE Photobiomodulation Therapy (PBMT)
- DEVICE Sham-Photobiomodualtion Therapy (Sham-PBMT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2022-08-11 |
| Est. Completion | 2024-10-31 |
| Phase | NA |
What the finished NCT05763381 record still lists
NCT05763381 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Photobiomodulation Therapy (PBMT) is the first listed.
NCT05763381 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05763381 about?
NCT05763381 is a clinical study titled "Low-Level Laser Therapy for Plantar Fasciitis". Plantar fasciitis (PF), a degenerative injury of the connective tissue in the foot, results in pain-related disability in Service Members and contributes to decreased physical activity and excessive healthcare costs. Even if effective, current treatment protocols may require 6-12 months of therapy t...
What is the current status of trial NCT05763381?
This trial is currently completed. It is a NA study. The enrollment target is 71 participants. The study started on 2022-08-11. Estimated completion is 2024-10-31.
What interventions are being tested in trial NCT05763381?
The interventions under investigation include: Photobiomodulation Therapy (PBMT) (DEVICE), Sham-Photobiomodualtion Therapy (Sham-PBMT) (DEVICE).
Who is sponsoring clinical trial NCT05763381?
This trial is sponsored by The Geneva Foundation, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05763381's enrollment target sits among peer trials
71 1102nd of 2000 higher than 898 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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