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The Effect of Light Therapy on Post-Surgical Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03674697
Recruitment Status : Not yet recruiting
First Posted : September 17, 2018
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
Mohab Ibrahim, PhD MD, University of Arizona

Brief Summary:
Surgical pain may require significant amount of opioids. This is a serious medical problem, especially in the elderly. New methods are needed to help control surgical pain. This study investigates the pain-reducing effects of green light therapy on elderly patients. Our preclinical work illustrated that green light therapy relieved pain in rats. There were no side effects exhibited by the rats. Given the safety profile of the green light therapy, we propose a clinical trial to enroll patients scheduled for elective (non-emergency) knee replacement. The patients will be exposed to green light for 3 weeks prior to their surgery and for 10 additional weeks post-surgery. We will assess the efficacy of the green light therapy by comparing the amount of pain medications required by the treatment group (green light patients) vs the control group (white light) in the elderly patients. We will also assess the degree of pain relief, side effects, and inflammatory mediators for both groups. Our hypothesis is that green light therapy will reduce the need for opioids and the negative side effects associated with opioid use. Additionally, we will assess for increased mobility and independence in the elderly.

Condition or disease Intervention/treatment Phase
Acute Pain Arthropathy of Knee Device: Green LED vs White LED light therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Effect of Light Therapy on Post-Surgical Pain
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2021

Arm Intervention/treatment
Experimental: Active Treatment Group (Green LED)
Subjects will be exposed to a Green LED light for 3 weeks prior to surgery, during their hospital stay and for an additional 10 weeks after hospital discharge. Wattage: 8W; Voltage: 120V; Wavelength: 525 nm; Intensity: 4-100 Lux
Device: Green LED vs White LED light therapy
You will be asked to locate a dark room in your house three weeks prior to your surgery. You will place the provided LED strip near you on a flat surface and turn it on for 2 hours a day until the day of the surgery. You have the freedom to pick anytime during day or night to use the light. We will ask you to be as consistent as possible with the time you chose. You can engage in any activity to pass the time as long as it does not involve exposure to another light from an outside source (computers, TV, smart phones, tablets, etc…).

Placebo Comparator: Control Group (White LED)
Subjects will be exposed to a White LED light for 3 weeks prior to surgery, during their hospital stay and for an additional 10 weeks after hospital discharge. Wattage: 9.6W; Voltage: 120V. Intensity: 4-100 Lux
Device: Green LED vs White LED light therapy
You will be asked to locate a dark room in your house three weeks prior to your surgery. You will place the provided LED strip near you on a flat surface and turn it on for 2 hours a day until the day of the surgery. You have the freedom to pick anytime during day or night to use the light. We will ask you to be as consistent as possible with the time you chose. You can engage in any activity to pass the time as long as it does not involve exposure to another light from an outside source (computers, TV, smart phones, tablets, etc…).




Primary Outcome Measures :
  1. The primary outcome for this trial is the amount of pain reduction medication (Analgesics) used during surgical recovery. [ Time Frame: The amount of pain reducing medication used by the active treatment group and the control group will be compared during the 10 week period after hospital discharge. ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female 65 years or older
  2. scheduled for elective knee surgery

Exclusion Criteria:

  1. Inability to speak or understand English
  2. on chronic opioids exceeding 90 Morphine Milligram Equivalent (MME)/day
  3. History of severe psychiatric condition.
  4. If surgery is complicated by infection or other surgical complications.
  5. History of rheumatoid arthritis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674697


Contacts
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Contact: Mohab Ibrahim, PhD, MD 520-874-7246 mibrahim@anesth.arizona.edu

Sponsors and Collaborators
University of Arizona
Investigators
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Principal Investigator: Mohab Ibrahim, PhD, MD University of Arizona
Publications of Results:
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Responsible Party: Mohab Ibrahim, PhD MD, Associate Professor Anesthesiology, University of Arizona
ClinicalTrials.gov Identifier: NCT03674697    
Other Study ID Numbers: 1808848766
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Joint Diseases
Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Musculoskeletal Diseases