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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 is a NA study that has completed, run by The Geneva Foundation. The registered enrollment target is 71 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05763381
The ClinicalTrials.gov registry entry for NCT05763381 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Geneva Foundation, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Photobiomodulation Therapy (PBMT) is the first listed.
NCT05763381 reports 0 study locations.
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.
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