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Behavioural Intervention

Light Therapy for Chronic Pain

N/A

Recruiting

Led By Matthew C Mauck, MD, PhD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Individuals who experience an average pain severity greater than 7/10 in intensity at baseline

Individuals who have been diagnosed with fibromyalgia or chronic low back pain by their physician

Must not have

Alert and oriented, and able to provide informed consent

Vision disorders or conditions resulting in severe vision impairment or blindness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 week prior to baseline and 1 week during light stimulation

Awards & highlights

No Placebo-Only Group

Summary

This trial will test how light may reduce chronic pain severity & sensitivity in people with chronic back pain & fibromyalgia. Results may help design light therapies to help reduce pain.

Who is the study for?

Adults over 18 with fibromyalgia or chronic low back pain, who rate their pain at least 7/10, can join this trial. They must be willing to use a light therapy device for two hours each morning for five days and be able to read and speak English. People with seizure disorders, severe vision impairments, color blindness, pregnancy, or prisoners cannot participate.

What is being tested?

The study tests if different types of light stimuli (Green Light stimulation, Equal Energy White stimulation, S-cone modulating white light) presented through a portable device can reduce chronic pain severity and sensitivity in patients with conditions like fibromyalgia and lower back pain.

What are the potential side effects?

There are no specific side effects mentioned for the light therapies being tested in this trial. However, participants should report any discomfort or unexpected reactions during the treatment period.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My average pain level is more than 7 out of 10.

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I have been diagnosed with fibromyalgia or chronic low back pain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am mentally capable of understanding and agreeing to the trial.

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I have severe vision problems or am legally blind.

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I can read and speak English well enough to fill out questionnaires.

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I have a history of seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week prior to baseline and 1 week during light stimulation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 week prior to baseline and 1 week during light stimulation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week prior to baseline and 1 week during light stimulation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility: Percent follow-up

Feasibility: Percent of flash surveys completed

Feasibility: Self-reported light stimulation sessions completed

Secondary study objectives

Change in Conditioned Pain modulation

Change in Temporal Summation

Change in activity measured with an accelerometer

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: S-cone modulating white lightExperimental Treatment1 Intervention

The S-cone modulating light stimulus will alternate between two light conditions at 500 lux that will activate the S-cones by about 100x differentially between the two conditions while maintaining the L- an M-cones at constant activation between the two alternating conditions using 427 nm versus 545 nm light. The stimulus will be delivered by a portable battery-operated ganzfeld light stimulation device for 2 hours per day for 5 consecutive days.

Group II: Green light stimulusExperimental Treatment1 Intervention

Green light at 500 lux. Participants will view 545 nm green light delivered via a portable battery-operated ganzfeld light stimulation device for 2 hours per day for 5 consecutive days.

Group III: Equal energy white stimulusExperimental Treatment1 Intervention

Equal energy white light at 500 lux. The International Commission on Illumination (CIE) coordinates of this light are (x=y=0.33), indicating that the stimulus appears uniformly white which means that the activation of each of the three classes of photoreceptors are equivalent, thus silencing any chromatic opponency. The stimulus will be delivered by a portable battery-operated ganzfeld light stimulation device for 2 hours per day for 5 consecutive days.

0 / 6Eligibility criteria met