Study Stopped
Enrollment not achieved succesfully
Light Therapy in the Treatment of Leg Pain
MilCAM
Monochromatic Near-Infrared Light Energy (MIRE) in the Treatment of Tibial Stress Reaction
3 other identifiers
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2005
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 10, 2005
CompletedFirst Posted
Study publicly available on registry
November 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedResults Posted
Study results publicly available
June 19, 2014
CompletedJune 13, 2016
May 1, 2016
2.6 years
November 10, 2005
August 28, 2013
May 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual Analog Scale
Numeric scale based on pain level (1-10). The higher the numeric value, the higher the pain level, as perceived by the participant.
4 weeks
Study Arms (2)
Infrared Light Therapy
EXPERIMENTALIntervention: 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
PLACEBO COMPARATORStandard of care was characterized by the use of standard medical treatment to include medication.
Interventions
Subjects randomized to the intervention group (Monochromatic Near-Infrared Light Energy), received treatment three times a week for a total of four weeks.
Eligibility Criteria
You may qualify if:
- Active duty soldier
- Exertional leg pain of greater than 3 months duration
- Documented bone scintigraphic evidence for tibial stress reaction or fracture
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
William Beaumont Army Medical Center
El Paso, Texas, 79920, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- COL Richard Petri, Chief Integrative Pain Management
- Organization
- William Beaumont Army Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
LTC Richard P Petri, MD
Department of the Army
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2005
First Posted
November 15, 2005
Study Start
November 1, 2005
Primary Completion
June 1, 2008
Study Completion
November 1, 2008
Last Updated
June 13, 2016
Results First Posted
June 19, 2014
Record last verified: 2016-05