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Completed

NCT Number: NCT00426166

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).

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Key information

Conditions

Wound Healing

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Toledo, Health Science Campus

Toledo, Ohio, 43614, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low Level Laser Therapy

Device

7500 megawatts with a 980 nm treatment beam every 48 hours for two weeks beginning at suture removal.

Primary outcomes

  1. FACES Pain Rating Scale Scores

    Time frame: baseline (2 weeks after surgery)

    The FACES pain scale ranged from 0-10, with lower scores representing less pain and better outcome.

  2. FACES Pain Rating Scale Scores

    Time frame: 6 weeks after surgery

    The FACES pain scale ranged from 0-10, with lower scores representing less pain and better outcome.

  3. FACES Pain Rating Scale.

    Time frame: 12 weeks after surgery

    The FACES pain scale ranged from 0-10, with lower scores representing less pain and better outcome.

Secondary outcomes

  1. 36-Item Short Form Survey - Bodily Pain Scores

    Time frame: 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.

  2. 36-Item Short Form Survey - Bodily Pain Scores

    Time frame: 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.

  3. 36-Item Short Form Survey - Bodily Pain Scale

    Time frame: 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.

  4. 36-Item Short Form Survey - General Health

    Time frame: 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.

  5. 36-Item Short Form Survey - General Health

    Time frame: 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.

  6. 36-Item Short Form Survey - General Health

    Time frame: 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.

  7. 36-Item Short Form Survey - Physical Function

    Time frame: 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.

  8. 36-Item Short Form Survey - Physical Function

    Time frame: 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.

  9. 36-Item Short Form Survey - Physical Function

    Time frame: 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.

  10. 36-Item Short Form Survey - Mental Health

    Time frame: 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.

  11. 36-Item Short Form Survey - Mental Health

    Time frame: 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.

  12. 36-Item Short Form Survey - Mental Health

    Time frame: 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.

  13. 36-Item Short Form Survey - Social Function

    Time frame: 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.

  14. 36-Item Short Form Survey - Social Function

    Time frame: 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.

  15. 36-Item Short Form Survey - Social Function

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Toledo Health Science Campus

Other

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2011
First posted
Jan 24, 2007
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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