Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Light Therapy in the Treatment of Leg Pain (MilCAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00253981
Recruitment Status : Terminated (Enrollment not achieved succesfully)
First Posted : November 15, 2005
Results First Posted : June 19, 2014
Last Update Posted : June 13, 2016
Sponsor:
Collaborator:
William Beaumont Army Medical Center
Information provided by (Responsible Party):
Samueli Institute for Information Biology

Tracking Information
First Submitted Date  ICMJE November 10, 2005
First Posted Date  ICMJE November 15, 2005
Results First Submitted Date  ICMJE August 28, 2013
Results First Posted Date  ICMJE June 19, 2014
Last Update Posted Date June 13, 2016
Study Start Date  ICMJE November 2005
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2014)
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 Measures  ICMJE
 (submitted: November 14, 2005)
  • 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)
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2005)
  • 1. Time to normalized bone scintigraph
  • 2. Stopping of treadmill whether or not due to pain
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Light Therapy in the Treatment of Leg Pain
Official Title  ICMJE 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 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Tibial Fractures
  • Leg Injuries
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: 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.
    Intervention: Device: Monochromatic Near-Infrared Light Energy (MIRE)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 19, 2012)
30
Original Enrollment  ICMJE
 (submitted: November 14, 2005)
102
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00253981
Other Study ID Numbers  ICMJE WBAMC #05/13
CIRO #2005705 ( Other Identifier: CIRO #2005705 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Samueli Institute for Information Biology
Study Sponsor  ICMJE Samueli Institute for Information Biology
Collaborators  ICMJE William Beaumont Army Medical Center
Investigators  ICMJE
Principal Investigator: LTC Richard P Petri, MD Department of the Army
PRS Account Samueli Institute for Information Biology
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP