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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a light-based treatment called photobiomodulation therapy (PBMT) for plantar fasciitis, a painful foot condition. The researchers aim to determine if PBMT can reduce pain and improve foot function more effectively than a placebo treatment. Participants will receive either the active PBMT or a sham version, which acts as a pretend treatment. Ideal candidates are active-duty military members who have experienced plantar fasciitis pain for at least three months and can commit to the study's schedule. As an unphased trial, this study allows participants to contribute to innovative research that could lead to new treatment options for plantar fasciitis.

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 prior data suggests that this therapy is safe for treating plantar fasciitis?

Research has shown that photobiomodulation therapy (PBMT), which uses light to heal tissues, has been well-tolerated in past studies. For instance, one study with individuals suffering from plantar fasciitis (a painful foot condition) found that PBMT reduced pain and improved movement. Importantly, no serious side effects occurred, suggesting the therapy is safe for humans.

PBMT has also been tested on other conditions, like Achilles tendinopathy (a tendon issue), with positive safety results. This therapy is already used for several health problems, supporting its safety. However, while past results are promising, more research is needed to confirm its safety and effectiveness specifically for plantar fasciitis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Photobiomodulation Therapy (PBMT) for plantar fasciitis because it offers a non-invasive alternative to traditional treatments like physical therapy, orthotics, and anti-inflammatory medications. PBMT uses low-level lasers to stimulate cellular activity and promote healing, potentially reducing pain and inflammation more quickly and with fewer side effects than standard options. Unlike treatments that primarily offer symptomatic relief, PBMT targets the underlying cellular processes, making it a promising option for those seeking a long-term solution without the need for surgery or medication.

What evidence suggests that photobiomodulation therapy is effective for plantar fasciitis?

Research shows that photobiomodulation therapy (PBMT), which participants in this trial may receive, can help reduce pain and improve movement in people with plantar fasciitis. In previous studies, participants reported a noticeable decrease in pain, from an average score of 4.5 to 2.8, in just three weeks when PBMT was used along with their usual treatment. This therapy uses light to create positive changes in body tissues, which may explain its benefits for conditions like plantar fasciitis. PBMT has also shown potential in treating other tissue problems, such as Achilles tendinopathy. While these results are encouraging, more studies are needed to fully understand its effectiveness and improve treatment methods. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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

Concurrent participation in another research study addressing pain issue

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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. At the completion of the initial 6 weeks, the Usual Care + Sham (Placebo) PBM Group will be unblinded, and may choose to cross-over and complete another 6 weeks in the active treatment group. If participants choose to cross-over and receive active PBMT, they will re-complete all of the original study procedures (with the exception of screening, as participants have qualified for the study, and baseline data collection, as the study team will use the 6-week follow-up data as the new baseline prior to active PBMT 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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10761604/

Photobiomodulation Therapy Plus Usual Care Is Better ... Results. PBMT groups experienced a reduction in pain over the first three weeks (from an average of 4.5 to 2.8) after which their pain levels ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/16/NCT03015116/Prot_SAP_000.pdf

PROTOCOL TITLE: Effectiveness of Photobiomodulation ... Even if effective, current treatment protocols may require 6-12 months of therapy to return individuals to pain-free activity. Photobiomodulation (PBM), or low ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2468781221001624

Effect of low-level laser therapy on pain and disability in ... LLLT may improve pain in the short term and can be considered as a component of care of patients with PF. However, this superiority disappeared compared to ...

4. chattanoogarehab.com chattanoogarehab.com/us/blog/laser-therapy-with-eswt-for-plantar-fasciitis/

Clinical effectiveness of multi-wavelength photobiomodulation ... This study looks at the clinical effectiveness of combining laser therapy and shockwave therapy in the treatment of plantar fasciitis.

5. bmjopen.bmj.com bmjopen.bmj.com/content/12/9/e059479

Efficacy of low-level laser therapy in patients with lower ... Conclusion LLLT significantly reduces pain and disability in lower extremity tendinopathy and plantar fasciitis in the short and medium term. Long-term data ...

6. lightforcemedical.com lightforcemedical.com/conditions_treated_by_photobiomodulation/

What Conditions Can Photobiomodulation Treat? A Full List PBMT vs Traditional Treatments ; Plantar Fasciitis, ✓ Targeted, ⚠️ Pain relief only, ❌ Reserved for severe ; TMJ (Jaw Joint Pain), ✓ Yes, ⚠️ Limited ...

7. clinicaltrial.be clinicaltrial.be/en/details/261110?per_page=100&only_recruiting=0&only_eligible=0

Low-Level Laser Therapy for Plantar Fasciitis Photobiomodulation Therapy (PBMT): PBMT will be administered by a trained member of the study team using the LightForce® XPi therapy laser, ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37464155/

Effects of photobiomodulation therapy (PBMT) on the ... To review the effects of photobiomodulation therapy (PBMT) on pain intensity and disability in people with plantar fasciitis (PF) when compared ...