Clinical Trial: Light Therapy in the Treatment of Leg Pain

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Samueli Institute for Information Biology

Current Primary Outcome: Visual Analog Scale [ Time Frame: 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.


Original Primary Outcome:

  • 1. Time to complete Balke Protocol (completed at baseline, 2 months, 3 months, 6 months)
  • 2. Pain-pressure goniometric readings (completed at baseline, 1 month, 2 months, 3 months, 6 months)
  • 3. Visual Analog Score (completed at baseline, 1 month, 2 months, 3 months, 6 months)


Current Secondary Outcome:

Original Secondary Outcome:

  • 1. Time to normalized bone scintigraph
  • 2. Stopping of treadmill whether or not due to pain


Information By: Samueli Institute for Information Biology

Dates:
Date Received: November 10, 2005
Date Started: November 2005
Date Completion:
Last Updated: May 10, 2016
Last Verified: May 2016