Light Therapy in the Treatment of Leg Pain (MilCAM)

Samueli Institute for Information Biology

Status: Terminated

Conditions: Leg Injuries; Tibial Fractures

Treatments: Device: Monochromatic Near-Infrared Light Energy (MIRE)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00253981

CIRO #2005705 (Other Identifier)

WBAMC #05/13

NCT00253981 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Infrared Light Therapy

Experimental group

Description:

Intervention: The use of infrared light therapy for the treatment of tibial fracture. The treatment was assigned three times a week for four weeks.

Treatment:

Device: Monochromatic Near-Infrared Light Energy (MIRE)

Standard of Care

Placebo Comparator group

Description:

Standard of care was characterized by the use of standard medical treatment to include medication.

Treatment:

Device: Monochromatic Near-Infrared Light Energy (MIRE)