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The Effect of Light Therapy on Chronic Pain

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ClinicalTrials.gov Identifier: NCT03677206
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
University of Arizona

Tracking Information
First Submitted Date  ICMJE May 11, 2017
First Posted Date  ICMJE September 19, 2018
Last Update Posted Date February 20, 2019
Actual Study Start Date  ICMJE June 2016
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2018)
  • Decrease use of analgesics using self-reported survey. [ Time Frame: Three months ]
    Decrease in use of analgesics from baseline. Medications and doses of analgesics will be documented at baseline, during the study the subjects will document their daily analgesic usage, at the end of the study the analgesic usage will be compared to baseline usage.
  • Modified Pain Questionnaire [ Time Frame: Three Months ]
    Improve Pain intensity from baseline using a numerical value for pain assessment form ranging from 0-10, where 0 = no pain and 10= the worst pain possible. This questionnaire will be filled out weekly and assessed at the end of the study to see if their pain intensity has improved from their baseline values.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03677206 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2018)
  • Health-related quality of life using Using the EQ-5D (EuroQol five-dimension scale) [ Time Frame: Three Months ]
    Using the EQ-5D (EuroQol five-dimension scale) assessment questionnaire, this questionnaire consists of five questions assessing the mobility, self care, ability to perform daily activity and overall functionality, pain discomfort, and anxiety are all scales that have 5 different answers to choose from consisting of one, to having no problems, to five being unable to. This will be a weekly questionnaire that will be assessed at the end of the study to check for improvements. Values of these assessments are scored, lower values are better.
  • Visual Analog Score (VAS) [ Time Frame: Three Months ]
    VAS, which is a scale of 0 -100, 100 meaning the best health you can imagine and 0 means the worst health you can imagine. This will be a weekly questionnaire that will be assessed at the end of the study to check for improvements.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Light Therapy on Chronic Pain
Official Title  ICMJE The Effect of Light Therapy on Chronic Pain
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.

Detailed Description

During the initial visit, the investigator will collect several pieces of data from participants that are considered part of the routine care, if you are being seen in the clinic, this information will also be used for research purposes. Initially the investigator will ask participants to provide their age, gender, work status, disability status, type of work, whether a previous pain physician has evaluated or provided treatment in the past, if there is any ongoing litigation, a detailed description of the pain (burning, electrical, shooting…etc.) and its location. If the participants are being seen in the clinic for their normal care a detailed physical examination assessing the motor strength of the upper extremities, sensation to light touch and reflexes that is part of the standard of care will be provided for the participants. The participants will be asked to give a numerical value for their pain (a scale from 0-10 where 0 is no pain and 10 is the worst pain imagined). Two questionnaires will be provided for the participants to complete which are not standard of care. The first one is the EQ-5D which provide an over assessment of the quality of life. The second is a medication log to document their analgesics use. If the participants are being evaluated via telephone call, the same questions will be conducted, but no physical exam will be provided.

The participants will be assigned to either a white, or green light group. The participants have 50% chance of being in either group. Once the participants are assigned a light group, the participants will be given a strip of Light emitting diode, (LED) light that correspond to their color group. The participants will be asked to take and use the LED strip in a dark room in their house every day for two hours to be exposed to the light, the participants will do this for 10 weeks. The study start date and the outcome assessment timeline will begin from the date of your first exposure to the assigned light. The participants will be asked to complete their weekly questionnaires and daily log, these will be given to the participants on their first clinic visit or sent to the participants if they live out of town. There will be several follow up appointments as detailed below. There is a chance the participants may be asked to cross over into a different group from the one the participants were assigned.

For the follow up clinic visit or phone call (Week 10), data similar to the information gathered at the initial visit will be collected. The description of the pain (burning, electrical, shooting…etc.) and its location will be reviewed. A physical examination assessing for pain and sensation to light touch that is part of the standard of care will be provided for the participants. At the end of the study, the participants will be asked to return the LED strip, their logs and questionnaires.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Chronic Pain
Intervention  ICMJE
  • Device: Exposure to green LED light
    Participants will be exposed to green LED strip lights in a dark room for 2 hours a day.
  • Device: Exposure to white LED light
    Participants will be exposed to white LED strip lights in a dark room for 2 hours a day.
Study Arms  ICMJE
  • Sham Comparator: Exposure to white LED light.
    Subjects will exposed to white light provided to them, in their homes in a dark room for approximately 2 hours for 3 months
    Intervention: Device: Exposure to white LED light
  • Experimental: Exposure to green LED light
    Subjects will exposed to green light provided to them, in their homes in a dark room for approximately 2 hours for 3 months
    Intervention: Device: Exposure to green LED light
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 17, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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
  • 7-day average numeric pain score of 5/10 or greater at baseline evaluation

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mohab Ibrahim, PhD., MD (520) 874-7246 mibrahim@anesth.arizona.edu
Contact: Amol Patwardhan, PhD., MD (520) 874-7246 apatwardhan@anesth.arizona.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03677206
Other Study ID Numbers  ICMJE 1604514512
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Arizona
Study Sponsor  ICMJE University of Arizona
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mohab Ibrahim, PhD., MD University of Arizona
PRS Account University of Arizona
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP