Back to resultsChromatic Retinal Stimulation to Reduce Chronic Pain and Pain Sensitivity
Primary Purpose
Chronic Low-back Pain, Chronic Pain, Fibromyalgia
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Green Light stimulation
Equal Energy White stimulation
S-cone modulating white light
Sponsored by
About this trial
This is an interventional other trial for Chronic Low-back Pain
Eligibility Criteria
Inclusion Criteria: Adults greater than or equal to 18. Individuals who have been diagnosed with fibromyalgia or chronic low back pain by their physician. Individuals who experience an average pain severity greater than 7/10 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. Exclusion Criteria: Vision disorders or conditions resulting in severe vision impairment or blindness Individuals with self-report of color blindness Alert and oriented, and able to provide informed consent Ability to read and speak English to complete validated questionnaires. 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
Sites / Locations
- University Of North Carolina
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Equal energy white stimulus
Green light stimulus
S-cone modulating white light
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Feasibility: Percent follow-up
Percent follow-up for 1 week baseline visit. Follow-up greater than 70% will be considered feasible.
Feasibility: Percent of flash surveys completed
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
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 Outcome Measures
Change in pain intensity after stimulation
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
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
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
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
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.
Full Information
NCT ID
NCT05956067
First Posted
June 28, 2023
Last Updated
July 13, 2023
Sponsor
University of North Carolina, Chapel Hill
1. Study Identification
Unique Protocol Identification Number
NCT05956067
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 17, 2023 (Anticipated)
Primary Completion Date
July 17, 2025 (Anticipated)
Study Completion Date
July 29, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain, Chronic Pain, Fibromyalgia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Equal energy white stimulus
Arm Type
Experimental
Arm Description
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.
Arm Title
Green light stimulus
Arm Type
Experimental
Arm Description
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.
Arm Title
S-cone modulating white light
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Green Light stimulation
Intervention Description
A portable battery-operated ganzfeld light stimulation device will be used to deliver green light for 2 hours per day for 5 consecutive days.
Intervention Type
Other
Intervention Name(s)
Equal Energy White stimulation
Intervention Description
A portable battery-operated ganzfeld light stimulation device will be used to deliver white light for 2 hours per day for 5 consecutive days.
Intervention Type
Other
Intervention Name(s)
S-cone modulating white light
Intervention Description
A portable battery-operated ganzfeld light stimulation device will be used to deliver S-cone modulating light for 2 hours per day for 5 consecutive days.
Primary Outcome Measure Information:
Title
Feasibility: Percent follow-up
Description
Percent follow-up for 1 week baseline visit. Follow-up greater than 70% will be considered feasible.
Time Frame
1 week
Title
Feasibility: Percent of flash surveys completed
Description
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.
Time Frame
1 week
Title
Feasibility: Self-reported light stimulation sessions completed
Description
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.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Change in pain intensity after stimulation
Description
Pain intensity measured by a 0-10 numeric rating scale for overall pain. 0 represents no pain, and 10 represents the worst pain imaginable.
Time Frame
Baseline, 1 week
Title
Change in pressure pain threshold
Description
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.
Time Frame
Baseline, 1 week
Title
Change in Conditioned Pain modulation
Description
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.
Time Frame
Baseline, 1 week
Title
Change in Temporal Summation
Description
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.
Time Frame
Baseline, 1 week
Title
Change in activity measured with an accelerometer
Description
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.
Time Frame
1 week prior to baseline and 1 week during light stimulation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults greater than or equal to 18.
Individuals who have been diagnosed with fibromyalgia or chronic low back pain by their physician.
Individuals who experience an average pain severity greater than 7/10 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.
Exclusion Criteria:
Vision disorders or conditions resulting in severe vision impairment or blindness
Individuals with self-report of color blindness
Alert and oriented, and able to provide informed consent
Ability to read and speak English to complete validated questionnaires.
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew C Mauck, MD, PhD
Phone
919-966-5136
Email
matt_mauck@med.unc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew C Mauck, MD, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified individual data that supports the results will be shared beginning 9 to 18 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina.
IPD Sharing Time Frame
Data will be available 1 year after completion of the study and will be available for an additional 2 years.
IPD Sharing Access Criteria
Data use agreement with University before deidentified information requested will be shared.
Learn more about this trial
Chromatic Retinal Stimulation to Reduce Chronic Pain and Pain Sensitivity
We'll reach out to this number within 24 hrs