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The purpose of this study is to examine whether or not Low Level Laser Therapy (LLLT) can reduce pain and/or improve wound healing in patients with an acute traumatic injury to the upper extremity (wrist, forearm, or elbow).
This is a prospective, two group, controlled study using random assignment. All eligible patients will be randomly assigned to one of two groups: the control group (usual care) or the experimental group (usual care plus LLLT). We plan to enroll 50 subjects in this study: 25 subjects will be randomly assigned to the LLLT group and 25 to the usual care group.
All subjects will be recruited within one to two days prior to hospital discharge or at the time of their first postoperative clinic visit. No subjects will be recruited while sedated or receiving intravenous pain medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Low Level Laser Therapy |
|
| 2 | No Intervention | No Laser Therapy. Outcome Measures the same. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Level Laser Therapy | Device | 7500 megawatts with a 980 nm treatment beam every 48 hours for two weeks beginning at suture removal. |
|
| Measure | Description | Time Frame |
|---|---|---|
| FACES Pain Rating Scale Scores | The FACES pain scale ranged from 0-10, with lower scores representing less pain and better outcome. | baseline (2 weeks after surgery) |
| FACES Pain Rating Scale Scores | The FACES pain scale ranged from 0-10, with lower scores representing less pain and better outcome. | 6 weeks after surgery |
| FACES Pain Rating Scale. | The FACES pain scale ranged from 0-10, with lower scores representing less pain and better outcome. | 12 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 36-Item Short Form Survey - Bodily Pain Scores | Response to questions generates a numerical score, with a higher score representing a better outcome. Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores. | baseline (2 weeks after surgery) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Skie, MD | University of Toledo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Toledo, Health Science Campus | Toledo | Ohio | 43614 | United States |
Per the initial IRB application, the criteria for selection and exclusion was based on the following:
Inclusion - Adult patients with unhealed wounds of the upper extremity.
For Outcome Measures, study results were destroyed/shredded based on 3 year minimum record retention after completion of research. Not able to provide patient reported ranges. Only data available is means.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Level Laser Therapy Group | Low Level Laser Therapy: 7500 megawatts with a 980 nm treatment beam every 48 hours for two weeks beginning at suture removal. |
| FG001 | Standard Treatment Control Group | No Laser Therapy. Outcome Measures the same. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Level Laser Therapy Group | Low Level Laser Therapy: Low Level Laser Therapy on Wound |
| BG001 | Standard Treatment Control Group | No Laser Therapy. Outcome Measures the same. |
| 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 | FACES Pain Rating Scale Scores | The FACES pain scale ranged from 0-10, with lower scores representing less pain and better outcome. | Posted | Mean | Full Range | units on a scale | baseline (2 weeks after surgery) |
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From the time of surgery to 12 weeks post op.
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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 | Low Level Laser Therapy | Low Level Laser Therapy: Low Level Laser Therapy on Wound |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Martin Skie | University of Toledo | 419-383-3515 | martin.skie@utoledo.edu |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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| 36-Item Short Form Survey - Bodily Pain Scores | Response to questions generates a numerical score, with a higher score representing a better outcome. Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores. | 6 weeks after surgery |
| 36-Item Short Form Survey - Bodily Pain Scale | Response to questions generates a numerical score, with a higher score representing a better outcome. Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores. | 12 weeks after surgery |
| 36-Item Short Form Survey - General Health | Response to questions generates a numerical score, with a higher score representing a better outcome. Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores. | 2 weeks after surgery (baseline) |
| 36-Item Short Form Survey - General Health | Response to questions generates a numerical score, with a higher score representing a better outcome. Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores. | 6 weeks after surgery |
| 36-Item Short Form Survey - General Health | Response to questions generates a numerical score, with a higher score representing a better outcome. Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores. | 12 weeks after surgery |
| 36-Item Short Form Survey - Physical Function | Response to questions generates a numerical score, with a higher score representing a better outcome. Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores. | 2 weeks after surgery (baseline) |
| 36-Item Short Form Survey - Physical Function | Response to questions generates a numerical score, with a higher score representing a better outcome. Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores. | 6 weeks after surgery |
| 36-Item Short Form Survey - Physical Function | Response to questions generates a numerical score, with a higher score representing a better outcome. Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores. | 12 weeks after surgery |
| 36-Item Short Form Survey - Mental Health | Response to questions generates a numerical score, with a higher score representing a better outcome. Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores. | 2 weeks after surgery (baseline) |
| 36-Item Short Form Survey - Mental Health | Response to questions generates a numerical score, with a higher score representing a better outcome. Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores. | 6 weeks after surgery |
| 36-Item Short Form Survey - Mental Health | Response to questions generates a numerical score, with a higher score representing a better outcome. Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores. | 12 weeks after surgery |
| 36-Item Short Form Survey - Social Function | Response to questions generates a numerical score, with a higher score representing a better outcome. Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores. | 2 weeks after surgery (baseline) |
| 36-Item Short Form Survey - Social Function | Response to questions generates a numerical score, with a higher score representing a better outcome. Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores. | 6 weeks after surgery |
| 36-Item Short Form Survey - Social Function | Response to questions generates a numerical score, with a higher score representing a better outcome. Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores. | 12 weeks after surgery |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex/Gender, Customized | Number | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| Primary | FACES Pain Rating Scale Scores | The FACES pain scale ranged from 0-10, with lower scores representing less pain and better outcome. | Posted | Mean | Full Range | Units on a scale | 6 weeks after surgery |
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| Primary | FACES Pain Rating Scale. | The FACES pain scale ranged from 0-10, with lower scores representing less pain and better outcome. | Posted | Mean | Full Range | units on a scale | 12 weeks after surgery |
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| Secondary | 36-Item Short Form Survey - Bodily Pain Scores | Response to questions generates a numerical score, with a higher score representing a better outcome. Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores. | Posted | Mean | Full Range | Units in a scale | baseline (2 weeks after surgery) |
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| Secondary | 36-Item Short Form Survey - Bodily Pain Scores | Response to questions generates a numerical score, with a higher score representing a better outcome. Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores. | Posted | Mean | Full Range | Units on a scale | 6 weeks after surgery |
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| Secondary | 36-Item Short Form Survey - Bodily Pain Scale | Response to questions generates a numerical score, with a higher score representing a better outcome. Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores. | Posted | Mean | Full Range | Units on a scale | 12 weeks after surgery |
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| Secondary | 36-Item Short Form Survey - General Health | Response to questions generates a numerical score, with a higher score representing a better outcome. Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores. | Posted | Mean | Full Range | Units on a scale | 2 weeks after surgery (baseline) |
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| Secondary | 36-Item Short Form Survey - General Health | Response to questions generates a numerical score, with a higher score representing a better outcome. Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores. | Posted | Mean | Full Range | Units on a scale | 6 weeks after surgery |
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| Secondary | 36-Item Short Form Survey - General Health | Response to questions generates a numerical score, with a higher score representing a better outcome. Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores. | Posted | Mean | Full Range | Units on a scale | 12 weeks after surgery |
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| Secondary | 36-Item Short Form Survey - Physical Function | Response to questions generates a numerical score, with a higher score representing a better outcome. Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores. | Posted | Mean | Full Range | Units on a scale | 2 weeks after surgery (baseline) |
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| Secondary | 36-Item Short Form Survey - Physical Function | Response to questions generates a numerical score, with a higher score representing a better outcome. Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores. | Posted | Mean | Full Range | Units on a scale | 6 weeks after surgery |
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| Secondary | 36-Item Short Form Survey - Physical Function | Response to questions generates a numerical score, with a higher score representing a better outcome. Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores. | Posted | Mean | Full Range | Units on a scale | 12 weeks after surgery |
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| Secondary | 36-Item Short Form Survey - Mental Health | Response to questions generates a numerical score, with a higher score representing a better outcome. Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores. | Posted | Mean | Full Range | Units on a scale | 2 weeks after surgery (baseline) |
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| Secondary | 36-Item Short Form Survey - Mental Health | Response to questions generates a numerical score, with a higher score representing a better outcome. Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores. | Posted | Mean | Full Range | Units on a scale | 6 weeks after surgery |
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| Secondary | 36-Item Short Form Survey - Mental Health | Response to questions generates a numerical score, with a higher score representing a better outcome. Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores. | Posted | Mean | Full Range | Units on a scale | 12 weeks after surgery |
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| Secondary | 36-Item Short Form Survey - Social Function | Response to questions generates a numerical score, with a higher score representing a better outcome. Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores. | Posted | Mean | Full Range | Units on a scale | 2 weeks after surgery (baseline) |
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| Secondary | 36-Item Short Form Survey - Social Function | Response to questions generates a numerical score, with a higher score representing a better outcome. Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores. | Posted | Mean | Full Range | Units on a scale | 6 weeks after surgery |
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| Secondary | 36-Item Short Form Survey - Social Function | Response to questions generates a numerical score, with a higher score representing a better outcome. Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores. | Posted | Mean | Full Range | Units on a scale | 12 weeks after surgery |
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| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Standard Treatment Control Group | No Laser Therapy. Outcome Measures the same. | 0 | 14 | 0 | 14 | 0 | 14 |
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