Assessment Of Infrared Photobiotherapy for Improved Wound Healing

Not Applicable

Completed

Conditions: Wound Healing

Interventions: Device: Low Level Laser Therapy

Registration Number: NCT00426166

Lead Sponsor: University of Toledo Health Science Campus

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Low Level Laser Therapy	Low Level Laser Therapy

Primary Outcome Measures

Name	Time	Method
FACES Pain Rating Scale Scores	6 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 Outcome Measures

Name	Time	Method
36-Item Short Form Survey - Bodily Pain Scores	6 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 - 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.
36-Item Short Form Survey - General Health	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.
36-Item Short Form Survey - Physical Function	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.
36-Item Short Form Survey - Mental Health	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.
36-Item Short Form Survey - Social Function	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.