Clinical trial NCT05956067: Chromatic Retinal Stimulation to Reduce Chronic Pain and Pain Sensitivity
Official title: Chromatic Retinal Stimulation to Reduce Chronic Pain and Pain Sensitivity
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Chronic Low-back Pain
Chronic Pain
Fibromyalgia
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Participants with chronic pain conditions including chronic low back pain and fibromyalgia may benefit from light stimuli presented to the retina to reduce chronic pain severity and pain sensitivity. Participants will be recruited into this study and will be presented with one of three uniform light stimuli via a wide-field ganzfeld in three conditions to determine the retinal mechanisms that reduce pain. This work will lead to a greater understanding of retinal mechanisms that contribute to pain and will assist the design of future studies to harness the potential of light based pain therapies.


Eligibility criteria: Inclusion Criteria:

* Adults greater than or equal to 18 and less than or equal to 65.
* Individuals who have been diagnosed with fibromyalgia or chronic low back pain by their physician.
* Individuals who experience an average pain severity greater than 4/10 in intensity at baseline.
* Willingness to wear a battery-operated portable ganzfeld light stimulator device for 2 hours per day at the same time each day (ideally complete the light therapy session between 5 am-10 am each morning) for 5 days.
* Alert and oriented, and able to provide informed consent
* Ability to read and speak English to complete validated questionnaires.

Exclusion Criteria:

* Vision disorders or conditions resulting in severe vision impairment or blindness
* Individuals with self-report of color blindness
* Prisoner Status
* Pregnancy
* No other history or condition that would, in the investigator's judgment, indicate that the patient would very likely be non-compliant with the study or unsuitable for the study (e.g., might interfere with the study, confound interpretation, or endanger the patient).
* History of seizure disorder

Primary outcomes:
measure: Feasibility: Percent follow-up
timeFrame: 1 week
measure: Feasibility: Percent of flash surveys completed
timeFrame: 1 week
measure: Feasibility: Self-reported light stimulation sessions completed
timeFrame: 1 week
Secondary outcomes:
measure: Change in pain intensity after stimulation
timeFrame: Baseline, 1 week
measure: Change in pressure pain threshold
timeFrame: Baseline, 1 week
measure: Change in Conditioned Pain modulation
timeFrame: Baseline, 1 week
measure: Change in Temporal Summation
timeFrame: Baseline, 1 week
measure: Change in activity measured with an accelerometer
timeFrame: 1 week prior to baseline and 1 week during light stimulation
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University Of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Matthew C Mauck, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: