Leg Injuries, Tibial Fractures
Conditions
Keywords
Pain, Intractable, Infrared Rays, Leg
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.
Interventions
DEVICEMonochromatic 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.
Sponsors
William Beaumont Army Medical Center
Samueli Institute for Information Biology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Experimental The experimental group received the monochromatic light infrared energy treatment (MIRE). | 16 |
| Control The control group followed the standard of care for the treatment of shin splints, usually physical therapy and medication. | 14 |
| Total | 30 |
Baseline characteristics
| Characteristic | Experimental | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 14 Participants | 30 Participants |
| Region of Enrollment United States | 16 participants | 14 participants | 30 participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 15 Participants | 14 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 14 |
| serious Total, serious adverse events | 0 / 16 | 0 / 14 |
Outcome results
Primary
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.
Time frame: 4 weeks