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 20, 2014
Last verified: May 2014
Results First Received: August 28, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Tibial Fractures
Leg Injuries
Intervention: Device: Monochromatic Near-Infrared Light Energy (MIRE)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The recruitment took place between 2006-2007 at a military treatment facility.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Some participants were excluded due to deployment, military training that required them to leave the post.

Reporting Groups
  Description
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.
Standard of Care Standard of care was characterized by the use of standard medical treatment to include medication.

Participant Flow:   Overall Study
    Infrared Light Therapy     Standard of Care  
STARTED     16     14  
COMPLETED     16     14  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Experimental The experimental group received the monochromatic light infrared energy treatment (MIRE).
Control The control group followed the standard of care for the treatment of shin splints, usually physical therapy and medication.
Total Total of all reporting groups

Baseline Measures
    Experimental     Control     Total  
Number of Participants  
[units: participants]
  16     14     30  
Age  
[units: Participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     16     14     30  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     1     0     1  
Male     15     14     29  
Region of Enrollment  
[units: participants]
     
United States     16     14     30  



  Outcome Measures

1.  Primary:   Visual Analog Scale   [ Time Frame: 4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
N/A


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: COL Richard Petri, Chief Integrative Pain Management
Organization: William Beaumont Army Medical Center
phone: 915-742-3245
e-mail: richard.petri@amedd.army.mil


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
Results First Received: August 28, 2013
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board