MilCAM: Light Therapy in the Treatment of Leg Pain

• Sponsor: Samueli Institute for Information Biology (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00253981
• Collaborator: William Beaumont Army Medical Center (U.S. Fed)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 36
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tibial Fractures; Leg Injuries	Device: Monochromatic Near-Infrared Light Energy (MIRE)	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• 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
• Study Start Date: Nov 1, 2005
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Visual Analog Scale [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Samueli Institute for Information Biology
• ClinicalTrials.gov Identifier: NCT00253981
• Other Study ID Numbers: WBAMC #05/13; CIRO #2005705
• First Posted: Nov 15, 2005
• Last Update Posted: Jun 13, 2016
• Last Verified: May 1, 2016

• Keywords provided by Samueli Institute for Information Biology: Pain, Intractable; Infrared Rays; Leg
• Additional relevant MeSH terms: Tibial Fractures; Leg Injuries

Study Results

Participant Flow

Recruitment Details	The recruitment took place between 2006-2007 at a military treatment facility.
Pre-assignment Detail	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
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

Baseline Characteristics

Arm/Group Title	Experimental	Control	Total
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 Participants	16	14	30
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	16 100%	14 100%	30 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	1 6.3%	0 0%	1 3.3%
Male	15 93.8%	14 100%	29 96.7%
Region of Enrollment (participants) [Number]
United States	16 100%	14 100%	30 100%

Outcome Measures

1. Primary Outcome

Title	Visual Analog Scale
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Infrared Light Therapy	Standard of Care
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.
Measure Participants	0	0

Adverse Events

Arm/Group Title	Experimental		Control
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Experimental		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	Experimental		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/14 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.