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Low-Level Laser Therapy for Plantar Fasciitis
N/A
Waitlist Available
Research Sponsored by The Geneva Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-month
Summary
This trial aims to evaluate a new therapy to reduce pain and disability from foot injury in service members. Results will help inform best practices for treating foot-related issues.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed for PBMT or Sham-PBMT in this summary, potential risks may include skin warming due to light absorption which could lead to overheating of the skin especially where there is tattoo ink or scarring.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3-month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Baseline Data Collection CRF
Baseline Data Collection CRF (Fitzpatrick Skin Phototype)
Demographic Information
+3 moreTrial Design
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.
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Who is running the clinical trial?
Musculoskeletal Injury Rehabilitation Research for Operational ReadinessFED
3 Previous Clinical Trials
181 Total Patients Enrolled
The Geneva FoundationLead Sponsor
37 Previous Clinical Trials
13,551 Total Patients Enrolled
Uniformed Services University of the Health SciencesFED
124 Previous Clinical Trials
90,653 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have nerve damage or can't feel changes in skin temperature.I experience pain in my foot or heel at some point during the day.I have had injections, surgery, or other treatments for my condition before.I have had a traumatic injury to my foot or feet that still causes symptoms.I am not taking medications that make me sensitive to heat or light.I have been diagnosed with Plantar Fasciitis by a doctor.I have had symptoms of pulmonary fibrosis for at least 3 months.I can commit to a 6-week study and follow-ups at 3 and 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: The Usual Care + PBM Group
- Group 2: The Usual Care + Sham (Placebo) PBM Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.