Low-Level Laser Therapy for Plantar Fasciitis

Overseen By Jeremy D Schroeder, DO

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: The Geneva Foundation

Must not be taking: Heat/light sensitivity drugs

Disqualifiers: Pregnancy, Neuropathy, Sciatica, others

Compensation: Varies

Number of Visits: 12

Duration: 6 weeks

100 Participants Needed

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using medications that make you sensitive to heat or light, like doxycycline or naproxen.

What data supports the effectiveness of the treatment Photobiomodulation Therapy (PBMT) for plantar fasciitis?

Research shows that Photobiomodulation Therapy (PBMT) can effectively reduce pain and improve foot function in people with plantar fasciitis. It has been found to be more effective than some other treatments, like extracorporeal shock wave therapy, for pain relief. ^{1 2 3 4 5}

Is low-level laser therapy (also known as photobiomodulation therapy) safe for humans?

Research on photobiomodulation therapy (PBMT) for plantar fasciitis and other conditions suggests it is generally safe for humans, as no significant safety concerns have been reported in the studies reviewed. ^{2 3 4 5 6}

How does photobiomodulation therapy (PBMT) differ from other treatments for plantar fasciitis?

Photobiomodulation therapy (PBMT) is unique because it uses low-level laser light to reduce pain and improve foot function by decreasing the thickness of the plantar fascia, which is different from other treatments like corticosteroid injections or shock wave therapy. It is non-invasive and can be used alone or with exercise, showing superior pain relief compared to some other therapies. ^{2 5 6 7 8}

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

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive PBMT or Sham-PBMT 3 times a week for 3 weeks, along with a daily regimen of stretching and cryotherapy

6 weeks

9 visits (in-person)

Follow-up

Participants are monitored for changes in plantar fascia thickness and pain levels at 3 and 6 weeks, with long-term follow-up at 3 months

3 months

2 visits (in-person), remote follow-up

Open-label extension (optional)

Sham-PBMT participants may opt to cross-over to active PBMT for an additional 6 weeks

6 weeks

Treatment Details

Interventions

• Photobiomodulation Therapy (PBMT)
• Sham-Photobiomodulation Therapy (Sham-PBMT)

Trial Overview 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.

Participant Groups

Group I: The Usual Care + PBM Group Active Control 1 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 Group Placebo Group 1 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.

Who Is Running the Clinical Trial?

The Geneva Foundation

Lead Sponsor

Trials

39

Recruited

13,700+

Musculoskeletal Injury Rehabilitation Research for Operational Readiness

Collaborator

Trials

4

Recruited

280+

Uniformed Services University of the Health Sciences

Collaborator

Trials

130

Recruited

91,100+

Findings from Research

Low-level laser therapy (PBMT) significantly accelerates the healing of chronic diabetic foot ulcers (DFUs), with a mean closure time of 26 days observed in a study of 17 patients with type 2 diabetes.

The treatment also improved neuropathic symptoms, as indicated by a notable reduction in vibration pressure threshold, suggesting that PBMT combined with structured foot care can enhance overall foot health in diabetic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation therapy in neuroischaemic diabetic foot ulcers: a novel method of limb salvage. Maiya, AG., Kumar, AS., Hazari, A., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy of pharmacological and non-pharmacological therapies on pain intensity and disability for plantar fasciitis: a systematic review and meta-analysis. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Parameters and Effects of Photobiomodulation in Plantar Fasciitis: A Meta-Analysis and Systematic Review. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Clinical effectiveness of multi-wavelength photobiomodulation therapy as an adjunct to extracorporeal shock wave therapy in the management of plantar fasciitis: a randomized controlled trial. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Combination Therapy Versus Exercise and Orthotic Support in the Management of Pain in Plantar Fasciitis: A Randomized Controlled Trial. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Effects of photobiomodulation therapy (PBMT) on the management of pain intensity and disability in plantar fasciitis: systematic review and meta-analysis. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of low-level laser therapy on pain and disability in patients with plantar fasciitis: A systematic review and meta-analysis. [2022]

7. Turkey pubmed.ncbi.nlm.nih.gov

Comparison of effects of low level laser therapy and local corticosteroid injection in the treatment of plantar fasciitis. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Photobiomodulation therapy in neuroischaemic diabetic foot ulcers: a novel method of limb salvage. [2019]