Wound Healing
Conditions
Brief summary
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).
Detailed description
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.
Interventions
DEVICELow Level Laser Therapy
7500 megawatts with a 980 nm treatment beam every 48 hours for two weeks beginning at suture removal.
Sponsors
University of Toledo Health Science Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Age \> 18 and \< 85 years * Acute traumatic injury of an upper extremity (wrist, forearm, or elbow) * Currently resides within 100 miles of UMC
Exclusion criteria
* Pregnant * Pacemaker * Medications that have heat or light-sensitivity contraindications (such as: steroids, some antibiotics) * Two or more cardiac risk factors * Intraoperative complications * Wound infection * Open Wound
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FACES Pain Rating Scale Scores | baseline (2 weeks after surgery) | The FACES pain scale ranged from 0-10, with lower scores representing less pain and better outcome. |
| FACES Pain Rating Scale. | 12 weeks after surgery | The FACES pain scale ranged from 0-10, with lower scores representing less pain and better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 36-Item Short Form Survey - General Health | 2 weeks after surgery (baseline) | 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. |
| 36-Item Short Form Survey - Physical Function | 2 weeks after surgery (baseline) | 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. |
| 36-Item Short Form Survey - Bodily Pain Scores | baseline (2 weeks after surgery) | 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. |
| 36-Item Short Form Survey - Social Function | 2 weeks after surgery (baseline) | 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. |
| 36-Item Short Form Survey - Mental Health | 2 weeks after surgery (baseline) | 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. |
| 36-Item Short Form Survey - Bodily Pain Scale | 12 weeks after surgery | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Low Level Laser Therapy Group Low Level Laser Therapy: Low Level Laser Therapy on Wound | 13 |
| Standard Treatment Control Group No Laser Therapy. Outcome Measures the same. | 14 |
| Total | 27 |
Baseline characteristics
| Characteristic | Total | Low Level Laser Therapy Group | Standard Treatment Control Group |
|---|---|---|---|
| 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 | 27 Participants | 13 Participants | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 27 Participants | 13 Participants | 14 Participants |
| Region of Enrollment United States | 27 participants | 13 participants | 14 participants |
| Sex/Gender, Customized Unknown gender | 27 Participants | 13 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 14 |
| other Total, other adverse events | 0 / 13 | 0 / 14 |
| serious Total, serious adverse events | 0 / 13 | 0 / 14 |
Outcome results
Primary
FACES Pain Rating Scale.
The FACES pain scale ranged from 0-10, with lower scores representing less pain and better outcome.
Time frame: 12 weeks after surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Low Level Laser Therapy | FACES Pain Rating Scale. | 1.0 units on a scale |
| Standard Treatment Control Group | FACES Pain Rating Scale. | 1.5 units on a scale |
Primary
FACES Pain Rating Scale Scores
The FACES pain scale ranged from 0-10, with lower scores representing less pain and better outcome.
Time frame: baseline (2 weeks after surgery)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Low Level Laser Therapy | FACES Pain Rating Scale Scores | 2.0 units on a scale |
| Standard Treatment Control Group | FACES Pain Rating Scale Scores | 3.3 units on a scale |
Primary
FACES Pain Rating Scale Scores
The FACES pain scale ranged from 0-10, with lower scores representing less pain and better outcome.
Time frame: 6 weeks after surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Low Level Laser Therapy | FACES Pain Rating Scale Scores | 1.0 Units on a scale |
| Standard Treatment Control Group | FACES Pain Rating Scale Scores | 2.5 Units on a scale |
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.
Time frame: 12 weeks after surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Low Level Laser Therapy | 36-Item Short Form Survey - Bodily Pain Scale | 45 Units on a scale |
| Standard Treatment Control Group | 36-Item Short Form Survey - Bodily Pain Scale | 52 Units on a scale |
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.
Time frame: 6 weeks after surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Low Level Laser Therapy | 36-Item Short Form Survey - Bodily Pain Scores | 49 Units on a scale |
| Standard Treatment Control Group | 36-Item Short Form Survey - Bodily Pain Scores | 44 Units on a scale |
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.
Time frame: baseline (2 weeks after surgery)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Low Level Laser Therapy | 36-Item Short Form Survey - Bodily Pain Scores | 45 Units in a scale |
| Standard Treatment Control Group | 36-Item Short Form Survey - Bodily Pain Scores | 13 Units in a scale |
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.
Time frame: 6 weeks after surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Low Level Laser Therapy | 36-Item Short Form Survey - General Health | 75 Units on a scale |
| Standard Treatment Control Group | 36-Item Short Form Survey - General Health | 58 Units on a scale |
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.
Time frame: 2 weeks after surgery (baseline)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Low Level Laser Therapy | 36-Item Short Form Survey - General Health | 70 Units on a scale |
| Standard Treatment Control Group | 36-Item Short Form Survey - General Health | 54 Units on a scale |
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.
Time frame: 12 weeks after surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Low Level Laser Therapy | 36-Item Short Form Survey - General Health | 60 Units on a scale |
| Standard Treatment Control Group | 36-Item Short Form Survey - General Health | 55 Units on a scale |
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.
Time frame: 6 weeks after surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Low Level Laser Therapy | 36-Item Short Form Survey - Mental Health | 58 Units on a scale |
| Standard Treatment Control Group | 36-Item Short Form Survey - Mental Health | 71 Units on a scale |
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.
Time frame: 2 weeks after surgery (baseline)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Low Level Laser Therapy | 36-Item Short Form Survey - Mental Health | 59 Units on a scale |
| Standard Treatment Control Group | 36-Item Short Form Survey - Mental Health | 58 Units on a scale |
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.
Time frame: 12 weeks after surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Low Level Laser Therapy | 36-Item Short Form Survey - Mental Health | 60 Units on a scale |
| Standard Treatment Control Group | 36-Item Short Form Survey - Mental Health | 60 Units on a scale |
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.
Time frame: 2 weeks after surgery (baseline)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Low Level Laser Therapy | 36-Item Short Form Survey - Physical Function | 54 Units on a scale |
| Standard Treatment Control Group | 36-Item Short Form Survey - Physical Function | 52 Units on a scale |
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.
Time frame: 6 weeks after surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Low Level Laser Therapy | 36-Item Short Form Survey - Physical Function | 50 Units on a scale |
| Standard Treatment Control Group | 36-Item Short Form Survey - Physical Function | 70 Units on a scale |
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.
Time frame: 12 weeks after surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Low Level Laser Therapy | 36-Item Short Form Survey - Physical Function | 50 Units on a scale |
| Standard Treatment Control Group | 36-Item Short Form Survey - Physical Function | 63 Units on a scale |
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.
Time frame: 2 weeks after surgery (baseline)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Low Level Laser Therapy | 36-Item Short Form Survey - Social Function | 55 Units on a scale |
| Standard Treatment Control Group | 36-Item Short Form Survey - Social Function | 40 Units on a scale |
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.
Time frame: 6 weeks after surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Low Level Laser Therapy | 36-Item Short Form Survey - Social Function | 58 Units on a scale |
| Standard Treatment Control Group | 36-Item Short Form Survey - Social Function | 84 Units on a scale |
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.
Time frame: 12 weeks after surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Low Level Laser Therapy | 36-Item Short Form Survey - Social Function | 58 Units on a scale |
| Standard Treatment Control Group | 36-Item Short Form Survey - Social Function | 74 Units on a scale |