Light Bulb Stimuli to Reduce Chronic Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of North Carolina, Chapel Hill
About this trial
This pilot randomized, double-blind, crossover clinical trial will evaluate the feasibility and preliminary efficacy of chromatic (colored) light exposure for reducing pain severity and pain sensitivity in adults with fibromyalgia or chronic widespread pain and fatigue. Participants will complete daily symptom surveys throughout the study and undergo patient-reported outcome assessments and quantitative sensory testing at multiple timepoints.
Participants will be randomized to receive either S-cone stimulating chromatic light or equal-energy white light for 2 hours daily over a 7-day treatment period. Following a 1-week washout, participants will cross over to the alternate condition. Outcomes will examine feasibility, changes in pain severity, pain interference, and measures of pain sensitivity. Total study duration is approximately 35 days.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults ≥ 18 years of age.
Individuals who have been diagnosed with fibromyalgia or suffer from chronic widespread pain and fatigue.
An average pain severity ≥4 on the 0-10 NRS over the month prior to enrollment.
Pain symptoms present for 3 months or longer.
Disqualifiers
Vision disorders or conditions resulting in severe vision impairment or blindness
Individuals with self-report of color blindness, uveitis or cataracts.
Prisoner Status
Pregnancy
Trial design
Design model
Crossover
Treatments tested in this trial
S-Cone Stimulating Chromatic Light
DeviceParticipants receive exposure to S-cone stimulating chromatic light delivered via programmed TUO light bulbs. Light is administered for 2 hours daily for 7 consecutive days, ideally between 5:00 a.m. and 10:00 a.m.. Participants use the light in their home environment while engaging in normal daily activities. Light intensity is maintained at a minimum of twice the ambient room illumination using an illuminometer provided by the study. This intervention is designed to selectively stimulate short-wavelength-sensitive (S-cone) photoreceptors.
Equal-Energy White Light
DeviceParticipants receive exposure to a light that appears equal-energy white that flickers along the L/M axis delivered via programmed TUO light bulbs. Light is administered for 2 hours daily for 7 consecutive days, ideally between 5:00 a.m. and 10:00 a.m. Participants use the light in their home environment while engaging in normal daily activities. Light intensity is maintained at a minimum of twice the ambient room illumination using an illuminometer provided by the study. This intervention serves as the control condition for comparison with the S-cone stimulating chromatic light intervention.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: S-cone stimulating chromatic light first followed by equal-energy white lightExperimental treatment 2 interventions
Group B: Equal-energy white light first followed by S-cone stimulating chromatic lightExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Percentage of participants completing follow-up visits after each intervention period
Feasibility will be assessed by percentage of participants completing follow-up visits after each intervention period.
Time frame
Throughout study participation (35 days)2
Percentage of daily flash surveys completed during the two 7-day stimulation periods
Feasibility will be assessed by percentage of daily flash surveys completed during the two 7-day stimulation periods (14 eligible survey time points).
Time frame
Throughout the two 7-day stimulation periods (14 eligible survey timepoints during active treatment period)3
Percentage of prescribed light stimulation sessions completed based on participant self-report
Feasibility will be assessed by percentage of prescribed light stimulation sessions completed based on participant self-report.
Time frame
Throughout the two 7-day stimulation periods (14 eligible survey timepoints during active treatment period)Secondary outcomes
1
Pain Intensity
Pain severity will be measured using an 11-point Numeric Rating Scale (NRS), where 0 represents no pain and 10 represents the worst pain imaginable. Mean pain scores following S-cone stimulating light and equal-energy white light conditions will be compared.
Time frame
Baseline, post-treatment period 1 (Day 14), post-treatment period 2 (Day 28), and follow-up (Day 35)2
Pressure Pain Threshold
Pressure pain threshold will be assessed using a pressure algometer applied to the trapezius muscle. Outcomes will be recorded in kilograms of force per square centimeter (kgf/cm\^2). Higher values indicate greater pain tolerance and reduced pain sensitivity.
Time frame
Baseline, post-treatment period 1 (Day 14), and post-treatment period 2 (Day 28).3
Temporal Summation
Temporal summation will be assessed using a 256 millinewton (mN) pinprick stimulator. Pain intensity ratings following a single stimulus and a train of 10 repetitive stimuli will be used to quantify central pain facilitation. Lower temporal summation values indicate reduced pain sensitivity.
Time frame
Baseline, post-treatment period 1 (Day 14), and post-treatment period 2 (Day 28).4
Conditioned Pain Modulation
Conditioned pain modulation will be calculated as the difference in pressure pain threshold measured before and after a conditioning cold-water stimulus. Greater increases in pressure pain threshold following conditioning indicate more effective endogenous pain inhibition.
Time frame
Baseline, post-treatment period 1 (Day 14), and post-treatment period 2 (Day 28).Sponsors and contacts
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Source ClinicalTrials.gov
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