Light Therapy in the Treatment of Leg Pain

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2008-11-30

Brief Summary

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The purpose of this study is to apply Anodyne therapy to active duty soldiers, who have shin splints, to evaluate healing time and effectiveness.

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Detailed Description

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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.

Conditions

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Tibial Fractures Leg Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Monochromatic Near-Infrared Light Energy (MIRE)

Intervention Type DEVICE

Subjects randomized to the intervention group (Monochromatic Near-Infrared Light Energy), received treatment three times a week for a total of four weeks.

Standard of Care

Standard of care was characterized by the use of standard medical treatment to include medication.

Group Type PLACEBO_COMPARATOR

Monochromatic Near-Infrared Light Energy (MIRE)

Intervention Type DEVICE

Subjects randomized to the intervention group (Monochromatic Near-Infrared Light Energy), received treatment three times a week for a total of four weeks.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No