Light Therapy in the Treatment of Leg Pain (MilCAM)

May 10, 2016 updated by: Samueli Institute for Information Biology

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • El Paso, Texas, United States, 79920
        • William Beaumont Army Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Infrared Light Therapy
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)
Subjects randomized to the intervention group (Monochromatic Near-Infrared Light Energy), received treatment three times a week for a total of four weeks.
Placebo Comparator: Standard of Care
Standard of care was characterized by the use of standard medical treatment to include medication.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samueli Institute for Information Biology

Collaborators

William Beaumont Army Medical Center

Investigators

  • Principal Investigator: LTC Richard P Petri, MD, Department of the Army

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

November 10, 2005

First Submitted That Met QC Criteria

November 14, 2005

First Posted (Estimate)

November 15, 2005

Study Record Updates

Last Update Posted (Estimate)

June 13, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WBAMC #05/13
  • CIRO #2005705 (Other Identifier: CIRO #2005705)
  • NCT00253981 (Other Grant/Funding Number: NCT00253981)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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