Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06395584
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-04-29
Brief Title:
Light Therapy and MRI Imaging for Knee Osteoarthritis Pain
Sponsor:
Nova Scotia Health Authority
Organization:
Nova Scotia Health Authority
Study Overview
Official Title:
Analysis of the Central Pathways Responsible for Green Light Therapy-Induced Pain Relief in Osteoarthritis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Managing joint pain is one of the main goals for treating osteoarthritis OA and other musculoskeletal disorders Alleviating chronic pain pharmacologically has several potential drawbacks including diminishing efficacy toxicity adverse side-effects and patient anxiety Non-pharmacological approaches eg weight loss have also been found to be effective at controlling joint pain and can provide supplementary benefits The development of efficacious alternative treatments for arthritis pain which provide analgesia without adverse side-effects would be advantageous
Recently preclinical and clinical studies have demonstrated that green ambient light using light-emitting diodes LEDs produced profound analgesia in animal models and chronic pain patients Both migraineurs and fibromyalgia patients have both reported significant reductions in pain following 10 weeks of green LED exposure
It is unknown how green light reduces pain but it is believed to be in the connections between the visual and pain control centres in the brain Investigators will examine whether green light reduces OA knee pain by altering pain processes in the brain To assess this we will recruit 44 participants and randomly assign them to one of two groups one group will receive light treatments every day for 20 weeks and the other group will not We will ask both groups to report pain in daily pain diaries and ask both groups to have a series of 3 MRI brain scans to determine if light exposure changes how the brain processes pain
Recently preclinical and clinical studies have demonstrated that green ambient light using light-emitting diodes LEDs produced profound analgesia in animal models and chronic pain patients Both migraineurs and fibromyalgia patients have both reported significant reductions in pain following 10 weeks of green LED exposure
It is unknown how green light reduces pain but it is believed to be in the connections between the visual and pain control centres in the brain Investigators will examine whether green light reduces OA knee pain by altering pain processes in the brain To assess this we will recruit 44 participants and randomly assign them to one of two groups one group will receive light treatments every day for 20 weeks and the other group will not We will ask both groups to report pain in daily pain diaries and ask both groups to have a series of 3 MRI brain scans to determine if light exposure changes how the brain processes pain
Detailed Description:
Osteoarthritis OA is the most common form of arthritis yet treatment options are limited to pain management Non-steroidal anti-inflammatory drugs NSAIDs and corticosteroids are the pharmacological foundation of OA pain control however prolonged use can come with considerable potential side effects that compromise among others heart liver and bone health Thus alternative non-pharmacological treatments may prove beneficial for a safe and more desirable alleviation of arthritis pain
Recent preclinical and clinical studies discovered that viewing dim green ambient light for 1-2 hours per day for 10 weeks dramatically reduced pain levels Using light-emitting diodes migraineurs exposed to this green light therapy GLT reported a significant reduction in both headache days as well as headache intensity Treating the same study participants with white light as a control had no effect on reported pain levels indicating that light specifically in the green range was necessary for analgesia Critically exposure to these low intensity light-emitting diodes produced no adverse side-effects and was easily tolerated by patients
A pre-clinical study of rodents revealed that exposure to green light reduced joint pain in a rat model of OA and this effect was mediated in part by the endocannabinoid system The mechanism by which green light produces analgesia is unknown but there is believed to be neural connections between the visual system and pain control centres in the brain Endogenous opioid release and descending inhibitory pathways are also believed to be involved in GLT responses Whether green light alleviates OA pain by altering pain processes in the central nervous system has not been investigated Therefore the hypothesis to be tested in this project is The analgesic effect of green light therapy in OA is mediated by central inhibitory pain circuits
The primary specific aim of this project is to examine changes in brain circuitry in patients with OA following green light therapy We will achieve this by recruiting 44 participants with knee OA and randomly assigning them to an active group or a control group The active group will first receive a daily placebo white light intervention for 10 weeks followed by a daily treatment green light intervention for 10 weeks Participants will be asked to participate in brain imaging scans at baseline and then following white light intervention and green light interventions The control group will receive no light intervention but will be asked to participate in time-matched fMRI scans fMRI data will be compared between the active and control groups We will also ask participants in both groups to self-report measures of knee pain and functioning throughout the study using various questionnaires
Recent preclinical and clinical studies discovered that viewing dim green ambient light for 1-2 hours per day for 10 weeks dramatically reduced pain levels Using light-emitting diodes migraineurs exposed to this green light therapy GLT reported a significant reduction in both headache days as well as headache intensity Treating the same study participants with white light as a control had no effect on reported pain levels indicating that light specifically in the green range was necessary for analgesia Critically exposure to these low intensity light-emitting diodes produced no adverse side-effects and was easily tolerated by patients
A pre-clinical study of rodents revealed that exposure to green light reduced joint pain in a rat model of OA and this effect was mediated in part by the endocannabinoid system The mechanism by which green light produces analgesia is unknown but there is believed to be neural connections between the visual system and pain control centres in the brain Endogenous opioid release and descending inhibitory pathways are also believed to be involved in GLT responses Whether green light alleviates OA pain by altering pain processes in the central nervous system has not been investigated Therefore the hypothesis to be tested in this project is The analgesic effect of green light therapy in OA is mediated by central inhibitory pain circuits
The primary specific aim of this project is to examine changes in brain circuitry in patients with OA following green light therapy We will achieve this by recruiting 44 participants with knee OA and randomly assigning them to an active group or a control group The active group will first receive a daily placebo white light intervention for 10 weeks followed by a daily treatment green light intervention for 10 weeks Participants will be asked to participate in brain imaging scans at baseline and then following white light intervention and green light interventions The control group will receive no light intervention but will be asked to participate in time-matched fMRI scans fMRI data will be compared between the active and control groups We will also ask participants in both groups to self-report measures of knee pain and functioning throughout the study using various questionnaires
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None