Clinical trial NCT00426166: Assessment Of Infrared Photobiotherapy for Improved Wound Healing
Official title: Assessment of Infrared Photobiotherapy for Improved Wound Healing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Healing
Lead sponsor: University of Toledo
Sponsor class: OTHER
First posted: 2007-01-24
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: FACES Pain Rating Scale Scores
timeFrame: baseline (2 weeks after surgery)
measure: FACES Pain Rating Scale Scores
timeFrame: 6 weeks after surgery
measure: FACES Pain Rating Scale.
timeFrame: 12 weeks after surgery
Secondary outcomes:
measure: 36-Item Short Form Survey - Bodily Pain Scores
timeFrame: baseline (2 weeks after surgery)
measure: 36-Item Short Form Survey - Bodily Pain Scores
timeFrame: 6 weeks after surgery
measure: 36-Item Short Form Survey - Bodily Pain Scale
timeFrame: 12 weeks after surgery
measure: 36-Item Short Form Survey - General Health
timeFrame: 2 weeks after surgery (baseline)
measure: 36-Item Short Form Survey - General Health
timeFrame: 6 weeks after surgery
measure: 36-Item Short Form Survey - General Health
timeFrame: 12 weeks after surgery
measure: 36-Item Short Form Survey - Physical Function
timeFrame: 2 weeks after surgery (baseline)
measure: 36-Item Short Form Survey - Physical Function
timeFrame: 6 weeks after surgery
measure: 36-Item Short Form Survey - Physical Function
timeFrame: 12 weeks after surgery
measure: 36-Item Short Form Survey - Mental Health
timeFrame: 2 weeks after surgery (baseline)
measure: 36-Item Short Form Survey - Mental Health
timeFrame: 6 weeks after surgery
measure: 36-Item Short Form Survey - Mental Health
timeFrame: 12 weeks after surgery
measure: 36-Item Short Form Survey - Social Function
timeFrame: 2 weeks after surgery (baseline)
measure: 36-Item Short Form Survey - Social Function
timeFrame: 6 weeks after surgery
measure: 36-Item Short Form Survey - Social Function
timeFrame: 12 weeks after surgery
Other outcomes:
Locations:
city: Toledo
country: United States
facility: University of Toledo, Health Science Campus
state: Ohio
Study officials:
affiliation: University of Toledo
name: Martin Skie, MD
role: PRINCIPAL_INVESTIGATOR
References: