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Photobiomodulation Therapy for Stress Fractures (PM12 Trial)
N/A
Recruiting
Led By Daniel Rhon, DSc, PhD
Research Sponsored by Brooke Army Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weekly up to 6 weeks, 4 months
Awards & highlights
PM12 Trial Summary
This trial will compare how well a light therapy treatment helps bone stress injuries in military personnel compared to usual care. Follow-up for four months.
Who is the study for?
This trial is for military trainees aged 17-64 at Fort Sam Houston with a confirmed diagnosis of tibial or metatarsal stress injuries. They must understand English and commit to the study for up to 6 weeks, with follow-up through 4 months. Exclusions include recent dry needling, certain medical conditions like neuropathy, albinism, heart pacemakers, tattoos in treatment area, pregnancy plans during the study period, severe non-union fractures, light-induced allergies or eczema.Check my eligibility
What is being tested?
The trial tests photobiomodulation therapy (PBMT) alongside standard physical therapy for bone stress injuries versus a sham PBMT with standard care. Participants are randomly assigned to either active or placebo treatments and evaluated on recovery speed and improvements in pain and function.See study design
What are the potential side effects?
While specific side effects of PBMT aren't detailed here, common concerns may include skin irritation at the treatment site or discomfort during therapy sessions. The safety profile will be closely monitored given that participants have various exclusions related to sensitivity towards light-based therapies.
PM12 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weekly up to 6 weeks, 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weekly up to 6 weeks, 4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to Return to Duty
Secondary outcome measures
Defense and Veteran's Pain Rating Scale (DVPRS) with supplemental questions
Hopping Test
Lower Extremity Functional Scale (LEFS)
+1 moreOther outcome measures
Fredericson grading system
PM12 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Standard Physical Therapy and Photobiomodulation TherapyExperimental Treatment1 Intervention
61 Participants will be randomized to this group and will receive Photobiomodulation Therapy (PBMT) in addition to standard physical therapy.
Group II: Standard Physical Therapy and Sham Photobiomodulation TherapyPlacebo Group1 Intervention
61 Participants will be randomized to this group and will receive sham Photobiomodulation Therapy (PBMT) in addition to standard physical therapy.
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Who is running the clinical trial?
Uniformed Services University of the Health SciencesFED
119 Previous Clinical Trials
90,769 Total Patients Enrolled
Brooke Army Medical CenterLead Sponsor
120 Previous Clinical Trials
26,637 Total Patients Enrolled
The Geneva FoundationOTHER
33 Previous Clinical Trials
12,626 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a stress fracture in my tibia that is not on the inner side.My bone fracture has not healed and is considered severe.I experience ongoing or frequent pain, numbness, or tingling in my leg below the knee.I have used Depo Provera in the last 2 years.I have a tattoo in the area where I will receive light-based therapy.I have not had PRP, corticosteroid injections, or prolotherapy in the last 3 months.I have a diagnosed stress fracture in my foot or shin confirmed by imaging.I have been using anti-inflammatory steroids in the last two weeks.I have been diagnosed with an autoimmune disease.I am currently in a study for a specific bone injury treatment.I am between 17 and 64 years old.I have been diagnosed with an eating disorder in the past or currently.I have a light-induced allergy or photosensitive eczema.I have not had a menstrual period for 6 months or more, or I have had only 4-9 periods in the last year.I haven't taken any medications that make me sensitive to light or heat in the last 5 days.I have been diagnosed with neuropathy that affects my ability to feel pain.I have had dry needling therapy in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Physical Therapy and Sham Photobiomodulation Therapy
- Group 2: Standard Physical Therapy and Photobiomodulation Therapy
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are seniors above the age of 75 able to participate in this medical investigation?
"This experimental trial is open to applicants aged 17 - 64, with 73 patient studies available for those less than 18 and 321 trials reserved for the elderly."
Answered by AI
Am I eligible to join this experimental program?
"This clinical trial is seeking 122 individuals with stress fractures of the tibia who are between their 17th and 64th birthdays."
Answered by AI
Are there still vacancies for participants in this research endeavor?
"Clinicaltrials.gov reveals that this investigation is no longer taking in volunteers. It was initiated on the 1st of May, 2023 and last updated two days later; however, there are currently 393 other trials accepting enrollees."
Answered by AI
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