Chronic Low-back Pain, Chronic Pain, Fibromyalgia
Conditions
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.
Interventions
DEVICEGreen Light stimulation
A portable battery-operated ganzfeld light display will be used to deliver green light for 2 hours per day for 5 consecutive days.
DEVICEEqual Energy White stimulation
A portable battery-operated ganzfeld light display will be used to deliver white light for 2 hours per day for 5 consecutive days.
DEVICES-cone modulating white light
A portable battery-operated ganzfeld light display will be used to deliver S-cone modulating light for 2 hours per day for 5 consecutive days.
Sponsors
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Percent follow-up | 1 week | Percent follow-up for 1 week baseline visit. Follow-up greater than 70% will be considered feasible. |
| Feasibility: Percent of flash surveys completed | 1 week | Percent of flash surveys completed during light stimulation period. 0% is the lowest and 100% is the highest. Higher percentages indicate greater percent of flash surveys completed. |
| Feasibility: Self-reported light stimulation sessions completed | 1 week | Self-reported light stimulation sessions completed by flash survey administered after each light stimulation session over the 5 day stimulation period. Number of sessions will be reported the minimum is 0 and the maximum is 5. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain intensity after stimulation | Baseline, 1 week | Pain intensity measured by a 0-10 numeric rating scale for overall pain. 0 represents no pain, and 10 represents the worst pain imaginable. |
| Change in pressure pain threshold | Baseline, 1 week | Pressure Pain Threshold is the threshold in which pain is experienced in response to increasing force applied to the trapezius measured by a pressure algometer in kilograms of force per square centimeter (kgf/cm\^2). The higher the value, the higher the threshold. The maximum is 10 kgf/cm\^2 and minimum is 0. |
| Change in Conditioned Pain modulation | Baseline, 1 week | Conditioned Pain modulation magnitude will be calculated as the difference in mean pressure pain threshold (kgf/cm\^2) measured prior to and during the conditioning stimulus (cold water bath), with increases in pressure pain threshold during conditioning interpreted as evidence of efficient endogenous pain inhibition. |
| Change in Temporal Summation | Baseline, 1 week | Temporal Summation. The investigators will evaluate temporal summation using a 40g Neuropen applied to the skin of the volar forearm and lumbar region, following a train of 10 identical stimuli (1 Hz). Participants will report retrospectively, the pain intensity of the 1st and 10th pinprick using a 0-10 numerical rating scale (NRS). 0 is the minimum and 10 is the maximum pain intensity that will be reported. |
| Change in activity measured with an accelerometer | 1 week prior to baseline and 1 week during light stimulation | Activity will be measured by an accelerometer. Average daily step count for the duration of the stimulus. Average non-sedentary time in minutes will able be determined over the stimulation period and compared to the data collected over the 1 week run-in period. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMatthew C Mauck, MD, PhD
University of North Carolina, Chapel Hill
Outcome results
None listed