Analgesic Potential of Light Therapy in Knee Osteoarthritis

NCT05398666 | Active Not Recruiting DMC

• 1 other identifier: 154679
• Study Type: interventional
• Target: 46
• 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. The investigators aim to assess the analgesic potential of green light therapy for people living with knee osteoarthritis. Participants will be asked to keep a pain diary for 4 weeks prior to light intervention. All participants will first use a white LED (20 lux) for 1-2 hours per day in a dark room at home for 10 weeks. Following a 2-week washout period without light use, participants will use a green LED (20 lux) for 1-2 hours per day in a dark room at home for 10 weeks. Following completion of the intervention, the investigator will assess changes in reported pain and quality of life. The investigators hypothesize that participants will have improvements in pain intensity and quality of life following treatment with green LEDs.

Conditions

Osteo Arthritis 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 (3)

• Western Ontario and McMaster University Arthritis Index (WOMAC)

  24 weeks

• Global impression of change and satisfaction

  24 weeks

• Brief Pain Inventory Short Form

  24 weeks

Study Arms (2)

White LED

SHAM COMPARATOR

Participants will be asked to use white LEDs for 1-2 hours/day in a dark room in their home.

Device: White LED light; Device: Green LED light

Green LED

EXPERIMENTAL

Participants will be asked to use green LEDs for 1-2 hours/day in a dark room in their home.

Device: White LED light; Device: Green LED light

Interventions

White LED light 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 LED; White LED

Green LED light DEVICE

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

Green LED; White LED

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Osteoarthritis of the knee according to American College of Rheumatology criteria: Knee pain with 3 of the following: age \>50 years, stiffness less than 30 min, crepitus, bony tenderness, bony enlargement, no palpable warmth
• Moderate to severe pain, as defined by an average 7-day pain score of greater than 4.0 on an 11-point numerical rating scale for pain intensity (NRS-PI).
• All concurrent medications taken for any reason stable for 14 days
• Ability to follow protocol with reference to cognitive and situational factors (e.g. stable housing, ability to attend visits)
• Ability to read and write English
• Willing and able to give informed consent

You may not qualify if:

• Currently enrolled in other clinical trial involving a pharmaceutical treatment
• Arthroscopic surgery scheduled within 8 months of study initiation

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

NS Health

Halifax, Nova Scotia, B3H1V7, Canada

Location

Study Officials

• Karim Mukhida, MD, PhD

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will first receive White LED exposure, then they will be crossed over to Green LED exposure.

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 1, 2022
• Study Start: February 15, 2023
• Primary Completion: February 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)