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N/A N=69 Randomized Single-blind Supportive Care

Low-Level Laser Therapy for Plantar Fasciitis

Plantar Fascitis

Enrolled (actual)
69
Serious AEs
7.8%
Results posted
Jun 2025
Primary outcome: Primary: Foot and Ankle Ability Measure (FAAM) — 47.00; 45.28; 11.65; 11.72 Percentage of function

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Photobiomodulation Therapy (PBMT) (Device); Sham-Photobiomodualtion Therapy (Sham-PBMT) (Device)
Age
Adult · 18+ yrs
Sex
All
Sponsor
The Geneva Foundation
Primary completion
Oct 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Foot and Ankle Ability Measure (FAAM)
57.00; 16.11
PRIMARY
Foot and Ankle Ability Measure (FAAM)
57.00; 16.11
PRIMARY
Foot and Ankle Ability Measure (FAAM)
57.00; 16.11
PRIMARY
Foot and Ankle Ability Measure (FAAM)
57.00; 16.11
PRIMARY
Pain Diary Defense and Veterans Pain Rating Scale (DVPRS)
3.50
PRIMARY
Pain Diary Defense and Veterans Pain Rating Scale (DVPRS)
3.50
PRIMARY
Pain Diary Defense and Veterans Pain Rating Scale (DVPRS)
3.50
PRIMARY
Pain Diary Defense and Veterans Pain Rating Scale (DVPRS)
3.50
PRIMARY
Ultrasound Measurement (Plantar Fascial Thickness)
4.155; 4.665
PRIMARY
Ultrasound Measurement (Plantar Fascial Thickness)
4.155; 4.665
PRIMARY
Ultrasound Measurement (Plantar Fascial Thickness)
4.155; 4.665

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 will be collected for analysis. The proposed methods will allow the study team to establish if PBMT is clinically effective to accelerate recovery compared to Sham-PBMT and result in resolution of fascial thickening, decrease in pain, and improved function. LONG-TERM GOAL: The long-term goals of the research include developing PBMT protocols for broad application to other painful and duty-limiting conditions.

Eligibility Criteria

Inclusion Criteria

  • DEERS eligible
  • Able to read and understand English language for consent purposes
  • Experience pain in the bottom of foot and/or heel at any time during the day
  • Diagnosis of Plantar Fasciitis (PF) by a healthcare provider based on accepted diagnostic criteria
  • Abel to commit to study procedures, including a 6-week intervention and 3 month follow-up
  • Have experienced symptoms of PF for at least 3 months

Exclusion Criteria

  • Diagnosed with a calcaneal (heel) fracture by a healthcare provider
  • Currently pregnant or plan to become pregnant during intervention period (safety of PBM not established in pregnancy)
  • History of traumatic injury to symptomatic foot/feet
  • Previous surgery, or other invasive treatment for same condition
  • Significant portion of calf area covered in tattoos/ink/scarring (pigment in ink can absorb light, causing overheating of skin)
  • History of neuropathy or inability to detect changes in skin temperature (increased risk of skin warming due to inability to detect change)
  • Current use of medications associated with sensitivity to heat or light (e.g., amiodarone, chlorpromazine, doxycycline, hydrochlorothiazide, nalidixic acid, naproxen, piroxicam, tetracycline, thioridazine, voriconazole)
  • Concurrent participation in another research study addressing pain issue
  • Current use of pacemaker
  • Current or chronic sciatica resulting in chronic or intermittent lower extremity pain, numbness, or tingling
  • Previous enrollment in this study for contralateral foot
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05763381). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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