Light Therapy in the Treatment of Leg Pain

Not Applicable

Terminated

• Conditions: Tibial Fractures; Leg Injuries
• Interventions: Device: Monochromatic Near-Infrared Light Energy (MIRE)

• Registration Number: NCT00253981
• Lead Sponsor: Samueli Institute for Information Biology

Brief Summary

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

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.

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-11-10
• Study First Submitted QC: 2005-11-14
• Study First Posted: 2005-11-15
• Primary Completion: 2008-06
• Study Completion: 2008-11
• Results First Submitted: 2013-08-28
• Results First Submitted QC: 2014-05-20
• Results First Posted: 2014-06-19
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-06-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infrared Light Therapy	Monochromatic Near-Infrared Light Energy (MIRE)	Intervention: The use of infrared light therapy for the treatment of tibial fracture. The treatment was assigned three times a week for four weeks.
Standard of Care	Monochromatic Near-Infrared Light Energy (MIRE)	Standard of care was characterized by the use of standard medical treatment to include medication.

Primary Outcome Measures

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

Trial Locations

Locations (1)

William Beaumont Army Medical Center; 🇺🇸 El Paso, Texas, United States