Light Therapy in the Treatment of Leg Pain

Study Overview
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Brief Summary
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The purpose of this study is to apply Anodyne therapy to active duty soldiers, who have shin splints, to evaluate healing time and effectiveness.

Detailed Description
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Tibial stress reactions and fractures are often difficult to treat, and therefore, many soldiers proceed to a medical disability/discharge. It is felt that with the use of the MIRE technology, active duty soldiers with tibial stress reactions and fractures will heal more quickly and completely. All soldiers will have a documented bone scintigraph as evidence for tibial stress reaction or fracture prior to enrollment. In addition, pain-pressure goniometric measures and time to complete the Balke protocol will also be used to assess healing with the MIRE technology. Comparison: Soldiers with Active MIRE technology, compared to soldiers with Placebo MIRE technology.

Official Title
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Monochromatic Near-Infrared Light Energy (MIRE) in the Treatment of Tibial Stress Reaction

Conditions
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Tibial Fractures, Leg Injuries

Intervention / Treatment
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* Device: Monochromatic Near-Infrared Light Energy (MIRE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Active duty soldier Exertional leg pain of greater than 3 months duration Documented bone scintigraphic evidence for tibial stress reaction or fracture Exclusion Criteria: Known leg Pathology other than stress reaction or fracture Service members known to be leaving area within next 6 months Pregnant females High risk cardiopulmonary patients Patients with assisted walking devices Patients with two or more cardiac risk factors

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infrared Light Therapy<br>Intervention: The use of infrared light therapy for the treatment of tibial fracture. The treatment was assigned three times a week for four weeks. | Device: Monochromatic Near-Infrared Light Energy (MIRE)<br>* Subjects randomized to the intervention group (Monochromatic Near-Infrared Light Energy), received treatment three times a week for a total of four weeks.<br>|
| Placebo Comparator: Standard of Care<br>Standard of care was characterized by the use of standard medical treatment to include medication. | Device: Monochromatic Near-Infrared Light Energy (MIRE)<br>* Subjects randomized to the intervention group (Monochromatic Near-Infrared Light Energy), received treatment three times a week for a total of four weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale | Numeric scale based on pain level (1-10). The higher the numeric value, the higher the pain level, as perceived by the participant. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leg, Pain, Intractable, Infrared Rays