Assessment Of Infrared Photobiotherapy for Improved Wound Healing

Assessment of Infrared Photobiotherapy for Improved Wound Healing

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).

Study Overview

• Status: Completed
• Conditions: Wound Healing
• Intervention / Treatment: Device: Low Level Laser Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Toledo, Ohio, United States, 43614
      • University of Toledo, Health Science Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Low Level Laser Therapy	Device: Low Level Laser Therapy; 7500 megawatts with a 980 nm treatment beam every 48 hours for two weeks beginning at suture removal.
No Intervention: 2; No Laser Therapy. Outcome Measures the same.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)
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

Collaborators and Investigators

• Sponsor: University of Toledo Health Science Campus
• Investigators: Principal Investigator: Martin Skie, MD, University of Toledo

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: January 22, 2007
• First Submitted That Met QC Criteria: January 23, 2007
• First Posted (Estimated): January 24, 2007

Study Record Updates

• Last Update Posted (Actual): April 23, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: Wound Healing