Light Therapy and MRI Imaging for Knee Osteoarthritis Pain

NCT06395584 | Active Not Recruiting

• 1 other identifier: 63924
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Pain Score Diary

  Change in mean daily pain diary score from baseline (average pain score over 7 days pre-treatment) to post treatment

  24 weeks

Secondary Outcomes (8)

• The Western Ontario and McMaster University Arthritis Index

  24 weeks

• The Brief Pain Inventory Short Form

  24 weeks

• The Global Impression of Change and Satisfaction

  24 weeks

• The Pain Catastrophizing Scale

  24 weeks

• Five Facet Mindfulness Questionnaire

  24 weeks

Other Outcomes (1)

• fMRI brain scans

  24 weeks

Study Arms (2)

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.

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.

Interventions

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.

Light therapy group

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.

Light therapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Osteoarthritis of the knee
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

NS Health

Halifax, Nova Scotia, B3H1V7, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Karim Mukhida, MD, PhD

  NS Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants assigned to the light therapy treatment group will use two different colours of light (white and green). One colour is a treatment light and the other is a placebo. Participants will not be told which is the treatment colour and which is the placebo.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to two groups: one group will receive daily light therapy treatments and the second group will not.

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 2, 2024
• Study Start: June 25, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: August 23, 2024

Record last verified: 2024-08

Locations

CA (1)