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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: May 10, 2016
Last verified: May 2016
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Monochromatic Near-Infrared Light Energy (MIRE) in the Treatment of Tibial Stress Reaction

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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.


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.
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.

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   (Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: Samueli Institute for Information Biology
ClinicalTrials.gov Identifier: NCT00253981     History of Changes
Other Study ID Numbers: WBAMC #05/13
CIRO #2005705 ( Other Identifier: CIRO #2005705 )
Study First Received: November 10, 2005
Results First Received: August 28, 2013
Last Updated: May 10, 2016

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

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

ClinicalTrials.gov processed this record on September 21, 2017