Low-Level Laser Therapy for Plantar Fasciitis

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: The Geneva Foundation

Trial Summary

What is the purpose of this trial?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

Active-duty military members with a healthcare provider's diagnosis of Plantar Fasciitis, experiencing foot pain for at least 3 months, and able to commit to a 6-week treatment plus follow-ups. Excludes pregnant individuals, those on light/heat-sensitive meds or pacemakers, prior invasive treatments for the condition, significant tattoos/scarring on calves, neuropathy sufferers, and participants in other pain studies.

Inclusion Criteria

I experience pain in my foot or heel at some point during the day.

DEERS eligible

Able to read and understand English language for consent purposes

+4 more

Exclusion Criteria

I have nerve damage or can't feel changes in skin temperature.

Concurrent participation in another research study addressing pain issue

I have had injections, surgery, or other treatments for my condition before.

+6 more

Participant Groups

The trial is testing Photobiomodulation Therapy (PBMT) against Sham-PBMT to see if PBMT can improve foot function and reduce pain more effectively. Up to 100 service members will be randomly assigned to either group and monitored over time for changes in foot function, pain levels, and plantar fascial thickness.

2Treatment groups

Active Control

Placebo Group

Group I: The Usual Care + PBM GroupActive Control1 Intervention

Participants that are assigned to this group will receive active treatment with PBM 3 times a week for 3 weeks for a total of 9 treatments.

Group II: The Usual Care + Sham (Placebo) PBM GroupPlacebo Group1 Intervention

Participants that are assigned to this group will receive Sham PBM therapy 3 times a week for 3 weeks for a total of 9 treatments. Sham PBM therapy is an inactive harmless treatment that is intended to mimic the active PBM treatment.