Light Therapy in the Treatment of Leg Pain - Full Text View

Sponsors and Collaborators:	Samueli Institute for Information Biology William Beaumont Army Medical Center
Information provided by:	Samueli Institute for Information Biology
ClinicalTrials.gov Identifier:	NCT00253981

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)

MedlinePlus related topics: Fractures Leg Injuries and Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Monochromatic Near-Infrared Light Energy (MIRE) in the Treatment of Tibial Stress Reaction

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 ]
Pain-pressure goniometric readings [ Time Frame: Baseline, 1 mth, 2 mths, 3 mths, 6 mths ]
Visual Analog Score [ Time Frame: Baseline, 1 mth, 2 mths, 3 mths, 6 mths ]

Secondary Outcome Measures:

Time to normalized bone scintigraph
Stopping of treadmill whether or not due to pain

Estimated Enrollment:	102
Study Start Date:	November 2005
Estimated Study Completion Date:	November 2008

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

Study ID Numbers:	WBAMC #05/13, CIRO #2005705
Study First Received:	November 10, 2005
Last Updated:	October 17, 2008
ClinicalTrials.gov Identifier:	NCT00253981
Health Authority:	United States: Institutional Review Board

Keywords provided by Samueli Institute for Information Biology:

Pain, Intractable
Infrared Rays
Leg

Study placed in the following topic categories:

Pain, Intractable
Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin

Stress
Leg Injuries
Pain
Tibial Fractures

ClinicalTrials.gov processed this record on January 14, 2009