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Active, Not Recruiting

NCT Number: NCT06395584

Light Therapy and MRI Imaging for Knee Osteoarthritis Pain

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NS Health

Halifax, Nova Scotia, B3H1V7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

White Light LED

Device

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 LED

Device

Participants will be exposed to green LED lights (4 lux) in a dark room for 1-2 hours per day for 10 weeks.

Primary outcomes

  1. 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

Secondary outcomes

  1. The Western Ontario and McMaster University Arthritis Index

    Time frame: 24 weeks

    Change in WOMAC score from baseline to post treatments

  2. The Brief Pain Inventory Short Form

    Time frame: 24 weeks

    Change in BPI score from baseline to post treatments

  3. The Global Impression of Change and Satisfaction

    Time frame: 24 weeks

    Change to quality of life will be assessed post treatments

  4. The Pain Catastrophizing Scale

    Time frame: 24 weeks

    Change in PCS score from baseline to post treatments

  5. Five Facet Mindfulness Questionnaire

    Time frame: 24 weeks

    Change in FFMQ score from baseline to post treatments

  6. The Spielberger Trait Anxiety Inventory

    Time frame: 24 weeks

    Change in STAI score from baseline to post treatments

  7. Pain vigilance questionnaire

    Time frame: 24 weeks

    Change in PVAQ score from baseline to post treatments

  8. Medication Quantification Scale

    Time frame: 24 weeks

    Change in MQS score from baseline to post treatments

Other outcomes

  1. fMRI brain scans

    Time frame: 24 weeks

    Examination of brain scans taken at baseline and (2) post treatments

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Registry information

Official study title

Analysis of the Central Pathways Responsible for Green Light Therapy-Induced Pain Relief in Osteoarthritis

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
May 2, 2024
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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