Light Therapy in the Treatment of Leg Pain

Tibial Fractures Clinical Trial

— MilCAM  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00253981
• Other study ID #: WBAMC #05/13
• Secondary ID: CIRO #2005705
• Status: Terminated
• Phase: N/A
• First received: November 10, 2005
• Last updated: May 20, 2014
• Start date: November 2005
• Est. completion date: November 2008

Study information

• Verified date: May 2014
• Source: Samueli Institute for Information Biology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: November 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leg Injuries
• Tibial Fractures

Intervention

Device:
• Monochromatic Near-Infrared Light Energy (MIRE)
Subjects randomized to the intervention group (Monochromatic Near-Infrared Light Energy), received treatment three times a week for a total of four weeks.

Locations

Country	Name	City	State
United States	William Beaumont Army Medical Center	El Paso	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Samueli Institute for Information Biology	William Beaumont Army Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No