The Effect of Light Therapy on Post-Surgical Pain

Summary

This is a prospective randomized clinical trial study to investigate two main aspects. The first aspect is to investigate the efficacy exposure to green light emitting diode (GLED) in reducing postoperative opioid medications requirements by 20% as the primary outcome amongst patients scheduled for elective total knee replacement surgery (knee arthroplasty). The second aspect is to reduce postoperative pain by 30%, improve preoperative anxiety by 30%, and improve the quality of sleep pre and postoperatively by 30%.

Seventy participants scheduled for elective unilateral primary total knee arthroplasty (total knee replacement) will be recruited from the pain clinic or from the orthopedic surgery clinics at Banner-University Medical Center by the pain or orthopedic physicians who are key personnel of this study. Once a participant is identified, he/she will meet with one of the research team members to explain the nature of the clinical trial and undergo a standard of care medical history gathering and baseline physical examinations. If the participant meets all the inclusion and have no exclusion criteria, he/she will be presented with a written consent in English to explain all the risk and benefits of this clinical trial. Once a participant signs a consent, he or she will be randomized by the study statistician, in a 1:1 ratio to either a GLED group (treatment) or white light-emitting diode (WLED) group (control). The participant will be trained on how to use the light device by one of the research team members. All participants will be exposed to either GLED or WLED for 8 weeks prior to surgery and two additional weeks after surgery.

Conditions

• Acute Pain
• Arthropathy of Knee

Interventions

DEVICE

Green LED light therapy

You will be asked to locate a dark room in your house 8 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 (8 weeks). 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 your chosen time. 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, smartphones, tablets, etc.).

DEVICE

White LED light therapy

You will be asked to locate a dark room in your house 8 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 (8 weeks). 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 your chosen time. 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, smartphones, tablets, etc.).

Sponsors & Collaborators

• University of Arizona

  lead OTHER

Principal Investigators

• Mohab Ibrahim, PhD, MD · University of Arizona

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-09-05

Primary Completion

2027-10-01

Completion

2027-12-31

FDA Device

Yes

Countries

• United States

Study Locations