The Effect of Light Therapy on Chronic Pain

NCT03677206 | Active Not Recruiting Results

• 1 other identifier: 1604514512
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic pain is a major problem in the USA and the rest of the world, currently, all available pharmacological interventions carry with them significant side effects. Pain clinics are specially equipped to perform intentional pain procedures to manage pain. However, there remain groups of patients what neither benefit from pharmacological nor from interventional pain procedures. Other methods have shown only minor benefits such as hypnosis or cognitive behavioral therapy. Therefore, other techniques need to be investigated. Light therapy has been shown to have significant biological effects on humans. For example, light therapy is used to manage depression. Several clinical trials have shown that certain wavelengths of light can improve wound healing, decrease temporomandibular joint dysfunction (TMJ) pain, and decrease fear of back pain. In these trials, light was directed at the site of pain. In an attempt to better understand the effect of different wavelengths of light, pre-clinical studies were conducted using rats. The investigators have shown green and blue Light emitting diode, (LED) light produced antinociception (analgesia) and reversed neuropathic pain associated with several models of chronic pain. The analgesic effect of light was completely blocked when rats had their eyes covered, this suggests that the analgesic effects seen are mainly due to systemic effect through the visual system. Preliminary experiments on rats suggest that this effect is mediated through the endogenous opioids and cannabinoid system. The investigators believe that LED light is a safe alternative to pharmacological intervention to manage pain by stimulating the endogenous endorphin and cannabinoid systems. The investigators initial target participants with history of HIV, chemotherapy induced peripheral neuropathy and fibromyalgia. Participants will be divided into 2 groups. The first group will be a control group exposed to white LED light. The second group will be exposed to green LED light, respectively. Participants will be asked to take LED light home and will be asked to set in a dark room for 2 hours daily for 3 months with their LED light on. At the end of the 3 months trial, the investigator will assess their pain intensity, analgesic use, and overall quality of life. The investigators hypothesis is that participants exposed to green and blue light will have less use of analgesics and will have better life quality.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• For Chronic Pain

  Change in the intensity of chronic pain as measured by the Numerical Pain Scale (NPS). The NPS has a value ranging from 0 to 10 out of a maximum of 10. 0 means no pain. 10 means the most severe pain.

  baseline and 10 - 22 weeks, depending on study arm

Secondary Outcomes (3)

• Fibromyalgia Impact Questionnaire

  baseline and 10 - 22 weeks, depending on study arm

• Headache Impact Test-6

  baseline and 10 - 22 weeks, depending on study arm

• EQ-5D-5L

  baseline and 10 - 22 weeks, depending on study arm

Study Arms (3)

Exposure to white LED light.

SHAM COMPARATOR

Subjects will exposed to white light provided to them, in their homes in a dark room for approximately 2 hours for 10 weeks

Device: Exposure to white LED light

Exposure to green LED light

EXPERIMENTAL

Subjects will exposed to green light provided to them, in their homes in a dark room for approximately 2 hours for 10 weeks.

Device: Exposure to green LED light

Cross over

OTHER

Subject will be exposed to white light (sham) for 10 weeks, then have a wash out period for 2 weeks, then exposed to green light (experimental) for 10 weeks.

Device: Exposure to green LED light; Device: Exposure to white LED light

Interventions

Exposure to green LED light DEVICE

Participants will be exposed to green LED strip lights in a dark room for 2 hours a day.

Cross over; Exposure to green LED light

Exposure to white LED light DEVICE

Participants will be exposed to white LED strip lights in a dark room for 2 hours a day.

Cross over; Exposure to white LED light.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ages 18 - 80 able to understand English and comply with study protocol
• Peripheral neuropathy from HIV or chemotherapy.
• History of fibromyalgia
• Headaches
• Chronic Pain
• day average numeric pain score of 5/10 or greater at baseline evaluation

You may not qualify if:

• Subjects receiving remuneration for their pain treatment
• Subjects that are incarcerated
• Subjects unable to read English and complete assessments
• Addictive behavior, severe clinical depression, or psychotic features

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

Banner University Medical Center South

Tucson, Arizona, 85713, United States

Location

Related Publications (8)

• Institute of Medicine (US) Committee on Advancing Pain Research, Care, and Education. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington (DC): National Academies Press (US); 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK91497/

  PMID: 22553896 BACKGROUND

• Hooley JM, Franklin JC, Nock MK. Chronic pain and suicide: understanding the association. Curr Pain Headache Rep. 2014;18(8):435. doi: 10.1007/s11916-014-0435-2.

  PMID: 24916035 BACKGROUND

• 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 BACKGROUND

• Smith AA, Friedemann ML. Perceived family dynamics of persons with chronic pain. J Adv Nurs. 1999 Sep;30(3):543-51. doi: 10.1046/j.1365-2648.1999.01123.x.

  PMID: 10499210 RESULT

• Gray D, Coon H, McGlade E, Callor WB, Byrd J, Viskochil J, Bakian A, Yurgelun-Todd D, Grey T, McMahon WM. Comparative analysis of suicide, accidental, and undetermined cause of death classification. Suicide Life Threat Behav. 2014 Jun;44(3):304-16. doi: 10.1111/sltb.12079.

  PMID: 25057525 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

• Martin L, Porreca F, Mata EI, Salloum M, Goel V, Gunnala P, Killgore WDS, Jain S, Jones-MacFarland FN, Khanna R, Patwardhan A, Ibrahim MM. Green Light Exposure Improves Pain and Quality of Life in Fibromyalgia Patients: A Preliminary One-Way Crossover Clinical Trial. Pain Med. 2021 Feb 4;22(1):118-130. doi: 10.1093/pm/pnaa329.

  PMID: 33155057 DERIVED

• Martin LF, Patwardhan AM, Jain SV, Salloum MM, Freeman J, Khanna R, Gannala P, Goel V, Jones-MacFarland FN, Killgore WD, Porreca F, Ibrahim MM. Evaluation of green light exposure on headache frequency and quality of life in migraine patients: A preliminary one-way cross-over clinical trial. Cephalalgia. 2021 Feb;41(2):135-147. doi: 10.1177/0333102420956711. Epub 2020 Sep 9.

  PMID: 32903062 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Mohab Ibrahim
• Organization: University of Arizona

mohab@arizona.edu

(520) 626-7221

Study Officials

• Mohab Ibrahim, PhD., MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Comprehensive Pain Management Clinic Associate Professor, Anesthesiology

Model Details: Initially, patients will receive White LED exposure, then they will be crossed over to Green LED exposure. The patients will not be told which one is the treatment and which one is the control.

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: September 19, 2018
• Study Start: June 1, 2016
• Primary Completion: June 1, 2023
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 18, 2025
• Results First Posted: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)