Text Size

Light Therapy in the Treatment of Leg Pain (MilCAM)

This study has been terminated.
(Enrollment not achieved succesfully)
Sponsor:
Collaborator:
William Beaumont Army Medical Center
Information provided by (Responsible Party):
Samueli Institute for Information Biology
ClinicalTrials.gov Identifier:
NCT00253981
First received: November 10, 2005
Last updated: December 17, 2012
Last verified: December 2012
History of Changes
  Purpose

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


Condition Intervention
Tibial Fractures
Leg Injuries
 Device: Monochromatic Near-Infrared Light Energy (MIRE)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Monochromatic Near-Infrared Light Energy (MIRE) in the Treatment of Tibial Stress Reaction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Samueli Institute for Information Biology:

Primary Outcome Measures:
  • Time to complete Balke Protocol [ Time Frame: Baseline, 2 mths, 3 mths, 6 mths ] [ Designated as safety issue: No ]
  • Pain-pressure goniometric readings [ Time Frame: Baseline, 1 mth, 2 mths, 3 mths, 6 mths ] [ Designated as safety issue: No ]
  • Visual Analog Score [ Time Frame: Baseline, 1 mth, 2 mths, 3 mths, 6 mths ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: November 2005
Study Completion Date: November 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Monochromatic Near-Infrared Light Energy (MIRE)
Placebo Comparator: Standard of Care
Standard of care was characterized by the use of standard medical treatment to include medication.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00253981

Locations
United States, Texas
William Beaumont Army Medical Center
El Paso, Texas, United States, 79920
Sponsors and Collaborators
Samueli Institute for Information Biology
William Beaumont Army Medical Center
Investigators
Principal Investigator: LTC Richard P Petri, MD Department of the Army
  More Information

No publications provided

Responsible Party: Samueli Institute for Information Biology
ClinicalTrials.gov Identifier: NCT00253981     History of Changes
Other Study ID Numbers: WBAMC #05/13, CIRO #2005705
Study First Received: November 10, 2005
Last Updated: December 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Samueli Institute for Information Biology:
Pain, Intractable
Infrared Rays
Leg

Additional relevant MeSH terms:
Leg Injuries
Tibial Fractures
Wounds and Injuries
Fractures, Bone

ClinicalTrials.gov processed this record on May 22, 2013