The Effect of Light Therapy on Post-Surgical Pain

NCT03674697 | Active Not Recruiting FDA Device

• 1 other identifier: 1808848766
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• The amount of pain reducing medication used by the active treatment group and the control group.

  Change in postoperative opioid medications requirements by 20% as assessed by opioid medication logs

  10 week period

Secondary Outcomes (3)

• The amount of pain reducing medication used by the active treatment group and the control group assessed by the Brief Pain Inventory survey.

  10 week period

• The amount of pain reducing medication used by the active treatment group and the control group assessed by Amsterdam Preoperative Anxiety and Information Scale survey.

  10 week period

• The amount of pain reducing medication used by the active treatment group and the control group assessed by the Pittsburgh Sleep Quality Index survey.

  10 week period

Study Arms (2)

Active Treatment Group (Green LED)

EXPERIMENTAL

Subjects will be exposed to a Green LED light for 8 weeks prior to surgery, during their hospital stay and for an additional 2 weeks after hospital discharge.

Device: Green LED light therapy

Control Group (White LED)

PLACEBO COMPARATOR

Subjects will be exposed to a White LED light for 8 weeks prior to surgery, during their hospital stay and for an additional 2 weeks after hospital discharge.

Device: White LED light therapy

Interventions

Green LED light therapy DEVICE

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.).

Also known as: Treatment

Active Treatment Group (Green LED)

White LED light therapy DEVICE

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.).

Also known as: Control

Control Group (White LED)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female 18 years or older
• Scheduled for elective primary knee replacement surgery
• Able to understand, read, and write English

You may not qualify if:

• History of chronic pain requiring chronic opioids equal or greater than 90 Morphine Milligram Equivalent (MME)/day
• Severe psychological or psychiatric conditions
• Unanticipated surgical complications, such as prolonged bleeding requiring long hospital stay, infection, dehiscence, and airway complications (anesthesiologist unable to extubate secondary to pulmonary complications
• Surgery cannot be postponed eight weeks from the day of recruitment
• Colorblindness
• On disability, involved in a legal case pending, or receiving compensation for a work-related injury

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

Banner University Medical Center Tucson

Tucson, Arizona, 85724, United States

Location

Related Publications (4)

• Hassett AL, Aquino JK, Ilgen MA. The risk of suicide mortality in chronic pain patients. Curr Pain Headache Rep. 2014;18(8):436. doi: 10.1007/s11916-014-0436-1.

  PMID: 24952608 RESULT

• Chau DL, Walker V, Pai L, Cho LM. Opiates and elderly: use and side effects. Clin Interv Aging. 2008;3(2):273-8. doi: 10.2147/cia.s1847.

  PMID: 18686750 RESULT

• Hwang MH, Shin JH, Kim KS, Yoo CM, Jo GE, Kim JH, Choi H. Low level light therapy modulates inflammatory mediators secreted by human annulus fibrosus cells during intervertebral disc degeneration in vitro. Photochem Photobiol. 2015 Mar-Apr;91(2):403-10. doi: 10.1111/php.12415. Epub 2015 Jan 26.

  PMID: 25557915 RESULT

• Ibrahim MM, Patwardhan A, Gilbraith KB, Moutal A, Yang X, Chew LA, Largent-Milnes T, Malan TP, Vanderah TW, Porreca F, Khanna R. Long-lasting antinociceptive effects of green light in acute and chronic pain in rats. Pain. 2017 Feb;158(2):347-360. doi: 10.1097/j.pain.0000000000000767.

  PMID: 28092651 RESULT

MeSH Terms

Conditions

Acute Pain

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohab Ibrahim, PhD, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Anesthesiology

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 17, 2018
• Study Start: September 5, 2018
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)