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Light Therapy in the Treatment of Leg Pain (MilCAM)

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Tibial Fractures
Leg Injuries
Intervention Device: Monochromatic Near-Infrared Light Energy (MIRE)
Enrollment 30
Recruitment Details The recruitment took place between 2006-2007 at a military treatment facility.
Pre-assignment Details Some participants were excluded due to deployment, military training that required them to leave the post.
Arm/Group Title Infrared Light Therapy Standard of Care
Hide Arm/Group Description 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 was characterized by the use of standard medical treatment to include medication.
Period Title: Overall Study
Started 16 14
Completed 16 14
Not Completed 0 0
Arm/Group Title Experimental Control Total
Hide Arm/Group Description The experimental group received the monochromatic light infrared energy treatment (MIRE). The control group followed the standard of care for the treatment of shin splints, usually physical therapy and medication. Total of all reporting groups
Overall Number of Baseline Participants 16 14 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 14 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
16
 100.0%
14
 100.0%
30
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 14 participants 30 participants
Female
1
   6.3%
0
   0.0%
1
   3.3%
Male
15
  93.8%
14
 100.0%
29
  96.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 14 participants 30 participants
16 14 30
1.Primary Outcome
Title Visual Analog Scale
Hide Description Numeric scale based on pain level (1-10). The higher the numeric value, the higher the pain level, as perceived by the participant.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Infrared Light Therapy Standard of Care
Hide Arm/Group Description:
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 was characterized by the use of standard medical treatment to include medication.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Experimental Control
Hide Arm/Group Description The experimental group received the monochromatic light infrared red energy treatment (MIRE). The control group followed the standard of care for the treatment of shin splints, usually physical therapy and medication.
All-Cause Mortality
Experimental Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Experimental Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/14 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Experimental Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/14 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: COL Richard Petri, Chief Integrative Pain Management
Organization: William Beaumont Army Medical Center
Phone: 915-742-3245
EMail: richard.petri@amedd.army.mil
Layout table for additonal information
Responsible Party: Samueli Institute for Information Biology
ClinicalTrials.gov Identifier: NCT00253981    
Other Study ID Numbers: WBAMC #05/13
CIRO #2005705 ( Other Identifier: CIRO #2005705 )
First Submitted: November 10, 2005
First Posted: November 15, 2005
Results First Submitted: August 28, 2013
Results First Posted: June 19, 2014
Last Update Posted: June 13, 2016