Osteo Arthritis KneeNCT05398666
Analgesic Potential of Light Therapy in Knee Osteoarthritis
A study testing White LED light and Green LED light in people with Osteo Arthritis 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 to 80 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- White LED light and Green LED light
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteCanada
- Study dates
- 15 Feb 2023to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -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
Who cannot join
- Currently enrolled in other clinical trial involving a pharmaceutical treatment
- Arthroscopic surgery scheduled within 8 months of study initiation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Light Therapy in the Treatment Of Pain Caused By Osteoarthritis Of The Knee: A One-way Crossover Trial
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.
Read the detailed description
Osteoarthritis (OA) is a progressive joint disease that affects 13% of Canadians. Managing joint pain is one of the main goals for treating OA and other musculoskeletal disorders. Alleviating chronic pain pharmacologically has several potential drawbacks including diminishing efficacy, toxicity, adverse side-effects, and patient anxiety. Current treatments consist mainly of oral nonsteroidal anti-inflammatories which are associated with significant side-effects such as higher risk of gastrointestinal (GI)ulcers and upper GI bleeds. Opioids as well are used but again present the risk that are associated with sedation, constipation and for some individuals substance disorders and addiction. Non-pharmacological treatments for OA pain may be beneficial.
Recently, preclinical and clinical studies have demonstrated that green ambient light using light-emitting diodes (LEDs) produced profound analgesia in chronic pain patients. Migraineurs exposed to this green light therapy (GLT) for 1-2 hours per day for 10 weeks reported a significant reduction in both headache days as well as headache intensity. Similarly, fibromyalgia patients treated with the same conditions reported a significant reduction in average pain intensity. Both patient groups also reported improvements in quality-of-life following treatment as measured by the EQ-5D-5L survey and, importantly, no adverse events were reported. White LEDs were used as a control in both trials and did not provide any analgesic benefit.
In pre-clinical rodent models, activation of the endogenous opioid system appears to be contributing to the analgesic effects of green light therapy. It is unknown if green light therapy may also be beneficial for osteoarthritis pain.
This study is a one-way crossover clinical design to determine whether exposure to green light therapy will improve pain in patients with knee osteoarthritis.
Initially, patients will receive White LED exposure (intensity: 4 lux, 1-2 hr/day), then they will be crossed over to Green LED exposure (wavelength 525nm, intensity: 4 lux, 1-2 hrs/day). The patients will not be told which one is the treatment and which one is the control.
Fourty patients attending the Chronic Pain Management Clinic with knee OA (as defined by the American College of Rheumatology guidelines) will be recruited to the study. Participants will be required to attend 4 visits during the 26 week study. In this study two light treatments will be tested (white LED vs green LED). Following the first clinic visit, we will ask participants to gather baseline pain information for 4 weeks without any light intervention (NRS-PI Pain Scale recorded in a pain diary). During weeks 5-15 participants will be exposed to white LEDs for 1-2 hours per day in a dark room at home, patients will then undergo a 2 week washout period without LED use. Green LEDs will be provided for home use for 1-2 hours per day (in a dark room) for the final 10 weeks. Visits to the clinic will follow the completion of both the white-light and green light treatments. Participants will be required to complete the NRS-PI Pain Scale every day and questionnaires at every visit. Questionnaires include the Brief Pain Inventory Short Form, The Western Ontario and McMaster Universities Arthritis Index (WOMAC), and the EuropQol EQ-5D-5L.
- Conditions
- Osteo Arthritis Knee
- Being tested
- White LED light, Green LED light
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White LED lightDevice
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 lightDevice
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 |
|---|---|---|
| White LED | Sham comparator | Participants will be asked to use white LEDs for 1-2 hours/day in a dark room in their home. Receives: 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. Receives: Device: White LED light; Device: Green LED light |
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 (3)
Western Ontario and McMaster University Arthritis Index (WOMAC)
Change in WOMAC score from baseline to post treatment
Measured: 24 weeks
Global impression of change and satisfaction
Using the Global impression of change and satisfaction survey, changes in quality of life will be assessed following treatment
Measured: 24 weeks
Brief Pain Inventory Short Form
Changes in reported pain will be assessed by comparing baseline and post-treatment responses
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 posted1 Jun 2022
- Study start15 Feb 2023
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- Patients will first receive White LED exposure, then they will be crossed over to Green LED exposure.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 46 participants (actual)
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, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398666
- Sponsor's protocol ID
- 154679
- Status last verified
- Aug 2024
- First submitted
- 26 May 2022
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
- Investigation of Light Therapy in the Treatment Of Pain Caused By Osteoarthritis Of The Knee: A One-way Crossover Trial
- ClinicalTrials.gov ID
- NCT05398666
- Acronym / sponsor ID
- 154679
- Conditions
- Osteo Arthritis Knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 1 Jun 2022 (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.
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.
Detailed description
Osteoarthritis (OA) is a progressive joint disease that affects 13% of Canadians. Managing joint pain is one of the main goals for treating OA and other musculoskeletal disorders. Alleviating chronic pain pharmacologically has several potential drawbacks including diminishing efficacy, toxicity, adverse side-effects, and patient anxiety. Current treatments consist mainly of oral nonsteroidal anti-inflammatories which are associated with significant side-effects such as higher risk of gastrointestinal (GI)ulcers and upper GI bleeds. Opioids as well are used but again present the risk that are associated with sedation, constipation and for some individuals substance disorders and addiction. Non-pharmacological treatments for OA pain may be beneficial.
Recently, preclinical and clinical studies have demonstrated that green ambient light using light-emitting diodes (LEDs) produced profound analgesia in chronic pain patients. Migraineurs exposed to this green light therapy (GLT) for 1-2 hours per day for 10 weeks reported a significant reduction in both headache days as well as headache intensity. Similarly, fibromyalgia patients treated with the same conditions reported a significant reduction in average pain intensity. Both patient groups also reported improvements in quality-of-life following treatment as measured by the EQ-5D-5L survey and, importantly, no adverse events were reported. White LEDs were used as a control in both trials and did not provide any analgesic benefit.
In pre-clinical rodent models, activation of the endogenous opioid system appears to be contributing to the analgesic effects of green light therapy. It is unknown if green light therapy may also be beneficial for osteoarthritis pain.
This study is a one-way crossover clinical design to determine whether exposure to green light therapy will improve pain in patients with knee osteoarthritis.
Initially, patients will receive White LED exposure (intensity: 4 lux, 1-2 hr/day), then they will be crossed over to Green LED exposure (wavelength 525nm, intensity: 4 lux, 1-2 hrs/day). The patients will not be told which one is the treatment and which one is the control.
Fourty patients attending the Chronic Pain Management Clinic with knee OA (as defined by the American College of Rheumatology guidelines) will be recruited to the study. Participants will be required to attend 4 visits during the 26 week study. In this study two light treatments will be tested (white LED vs green LED). Following the first clinic visit, we will ask participants to gather baseline pain information for 4 weeks without any light intervention (NRS-PI Pain Scale recorded in a pain diary). During weeks 5-15 participants will be exposed to white LEDs for 1-2 hours per day in a dark room at home, patients will then undergo a 2 week washout period without LED use. Green LEDs will be provided for home use for 1-2 hours per day (in a dark room) for the final 10 weeks. Visits to the clinic will follow the completion of both the white-light and green light treatments. Participants will be required to complete the NRS-PI Pain Scale every day and questionnaires at every visit. Questionnaires include the Brief Pain Inventory Short Form, The Western Ontario and McMaster Universities Arthritis Index (WOMAC), and the EuropQol EQ-5D-5L.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Patients will first receive White LED exposure, then they will be crossed over to Green LED exposure.
| Arm | Type | Receives |
|---|---|---|
| White LED | Sham comparator | Device: White LED light, Device: Green LED lightParticipants will be asked to use white LEDs for 1-2 hours/day in a dark room in their home. |
| Green LED | Experimental | Device: White LED light, Device: Green LED lightParticipants will be asked to use green LEDs for 1-2 hours/day in a dark room in their home. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- -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
Key exclusion criteria (2 listed)
- Currently enrolled in other clinical trial involving a pharmaceutical treatment
- Arthroscopic surgery scheduled within 8 months of study initiation
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 LED lightParticipants will be exposed to white LED lights (4 lux) in a dark room for 1-2 hours per day for 10 weeks. | Device | Green LED, White LED |
| Green LED lightParticipants will be exposed to green LED lights (4 lux) in a dark room for 1-2 hours per day for 10 weeks. | Device | Green LED, White LED |
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
3 secondary outcomes
Western Ontario and McMaster University Arthritis Index (WOMAC)
Time frame: 24 weeks
Global impression of change and satisfaction
Time frame: 24 weeks
Brief Pain Inventory Short Form
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Individual participant dataSharing planned: No
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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
Nova Scotia Health Authority
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 LED light and Green LED light in people with Osteo Arthritis 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 6 inclusion and 2 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: status not confirmed, 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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.