Osteoarthritis, KneeNCT06395584
Light Therapy and MRI Imaging for Knee Osteoarthritis Pain
A study testing White Light LED and Green Light LED in people with Osteoarthritis, Knee, run by Nova Scotia Health Authority at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- White Light LED and Green Light LED
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- 25 Jun 2024to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteoarthritis of the knee
- 18 years of age or older
- Right-handedness
- Stable pain medication use during the previous 14 days
- At least 4/10 knee pain, on average during the previous 14 days
- Able to get onto an MRI table with minimal support
- Comfortable completing questionnaires and study tasks with English language instructions
Who cannot join
- Visual impairments that cannot be corrected using prescription glasses or contact lenses
- Currently enrolled in other clinical trial involving a pharmaceutical treatment
- Knee surgery scheduled within 8 months of study initiation
- History of cardiac, respiratory, or nervous system disease that may interfere with participation in the study or cause heightened potential for adverse outcome. For example: asthma or claustrophobia
- Presence of any contraindications to MRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of the Central Pathways Responsible for Green Light Therapy-Induced Pain Relief in Osteoarthritis
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- White Light LED, Green Light LED
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White Light LEDDevice
Participants will be exposed to white LED lights (4 lux) in a dark room for 1-2 hours per day for 10 weeks.
Green Light LEDDevice
Participants will be exposed to green LED lights (4 lux) in a dark room for 1-2 hours per day for 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Light therapy group | Active comparator | Participants will be asked to use two different colours of light for 1-2 hours/day in a dark room in their home for 20 weeks. They will first use a white light for 10 weeks, followed by a green light for 10 weeks. They will be asked to complete daily pain diaries and a series of 3 MRI brain scans. Receives: Device: White Light LED; Device: Green Light LED |
| No light therapy group | No intervention | Participants will not receive light intervention but will be asked to complete daily pain diaries and a series of 3 MRI brain scans. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score Diary
Change in mean daily pain diary score from baseline (average pain score over 7 days pre-treatment) to post treatment
Measured: 24 weeks
Secondary outcomes (8)
The Western Ontario and McMaster University Arthritis Index
Change in WOMAC score from baseline to post treatments
Measured: 24 weeks
The Brief Pain Inventory Short Form
Change in BPI score from baseline to post treatments
Measured: 24 weeks
The Global Impression of Change and Satisfaction
Change to quality of life will be assessed post treatments
Measured: 24 weeks
The Pain Catastrophizing Scale
Change in PCS score from baseline to post treatments
Measured: 24 weeks
Five Facet Mindfulness Questionnaire
Change in FFMQ score from baseline to post treatments
Measured: 24 weeks
The Spielberger Trait Anxiety Inventory
Change in STAI score from baseline to post treatments
Measured: 24 weeks
Pain vigilance questionnaire
Change in PVAQ score from baseline to post treatments
Measured: 24 weeks
Medication Quantification Scale
Change in MQS score from baseline to post treatments
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start25 Jun 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to two groups: one group will receive daily light therapy treatments and the second group will not.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karim Mukhida, MD, PhD, Principal investigator, NS Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395584
- Sponsor's protocol ID
- 63924
- Status last verified
- Aug 2024
- First submitted
- 29 Apr 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Central Pathways Responsible for Green Light Therapy-Induced Pain Relief in Osteoarthritis
- ClinicalTrials.gov ID
- NCT06395584
- Acronym / sponsor ID
- 63924
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 2 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to two groups: one group will receive daily light therapy treatments and the second group will not.
| Arm | Type | Receives |
|---|---|---|
| Light therapy group | Active comparator | Device: White Light LED, Device: Green Light LEDParticipants will be asked to use two different colours of light for 1-2 hours/day in a dark room in their home for 20 weeks. They will first use a white light for 10 weeks, followed by a green light for 10 weeks. They will be asked to complete daily pain diaries and a series of 3 MRI brain scans. |
| No light therapy group | No intervention | –Participants will not receive light intervention but will be asked to complete daily pain diaries and a series of 3 MRI brain scans. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Osteoarthritis of the knee
- 18 years of age or older
- Right-handedness
- Stable pain medication use during the previous 14 days
- At least 4/10 knee pain, on average during the previous 14 days
Key exclusion criteria (5 listed)
- Visual impairments that cannot be corrected using prescription glasses or contact lenses
- Currently enrolled in other clinical trial involving a pharmaceutical treatment
- Knee surgery scheduled within 8 months of study initiation
- History of cardiac, respiratory, or nervous system disease that may interfere with participation in the study or cause heightened potential for adverse outcome. For example: asthma or claustrophobia
- Presence of any contraindications to MRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| White Light LEDParticipants will be exposed to white LED lights (4 lux) in a dark room for 1-2 hours per day for 10 weeks. | Device | Light therapy group |
| Green Light LEDParticipants will be exposed to green LED lights (4 lux) in a dark room for 1-2 hours per day for 10 weeks. | Device | Light therapy group |
Primary outcome
Pain Score Diary
Time frame: 24 weeks
Change in mean daily pain diary score from baseline (average pain score over 7 days pre-treatment) to post treatment
8 secondary outcomes
The Western Ontario and McMaster University Arthritis Index
Time frame: 24 weeks
The Brief Pain Inventory Short Form
Time frame: 24 weeks
The Global Impression of Change and Satisfaction
Time frame: 24 weeks
The Pain Catastrophizing Scale
Time frame: 24 weeks
Five Facet Mindfulness Questionnaire
Time frame: 24 weeks
The Spielberger Trait Anxiety Inventory
Time frame: 24 weeks
Pain vigilance questionnaire
Time frame: 24 weeks
Medication Quantification Scale
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karim Mukhida, MD, PhD principal investigator
NS Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing White Light LED and Green Light LED in people with Osteoarthritis, Knee, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score Diary (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.