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| ID | Type | Description | Link |
|---|---|---|---|
| CIRO #2005705 | Other Identifier | CIRO #2005705 | |
| NCT00253981 | Other Grant/Funding Number | NCT00253981 |
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Enrollment not achieved succesfully
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| Name | Class |
|---|---|
| William Beaumont Army Medical Center | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infrared Light Therapy | Experimental | 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 | Placebo Comparator | Standard of care was characterized by the use of standard medical treatment to include medication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monochromatic Near-Infrared Light Energy (MIRE) | Device | Subjects randomized to the intervention group (Monochromatic Near-Infrared Light Energy), received treatment three times a week for a total of four weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| LTC Richard P Petri, MD | Department of the Army | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| William Beaumont Army Medical Center | El Paso | Texas | 79920 | United States |
Some participants were excluded due to deployment, military training that required them to leave the post.
The recruitment took place between 2006-2007 at a military treatment facility.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Standard of Care | Standard of care was characterized by the use of standard medical treatment to include medication. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental | The experimental group received the monochromatic light infrared energy treatment (MIRE). |
| BG001 | Control | The control group followed the standard of care for the treatment of shin splints, usually physical therapy and medication. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | 4 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental | The experimental group received the monochromatic light infrared red energy treatment (MIRE). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| COL Richard Petri, Chief Integrative Pain Management | William Beaumont Army Medical Center | 915-742-3245 | richard.petri@amedd.army.mil |
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| ID | Term |
|---|---|
| D013978 | Tibial Fractures |
| D007869 | Leg Injuries |
| D010148 | Pain, Intractable |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Control | The control group followed the standard of care for the treatment of shin splints, usually physical therapy and medication. | 0 | 14 | 0 | 14 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |