Knee Pain ChronicNCT07057063
Light Therapy on Pain and Synovitis
A study testing 810 nm Light Therapy in people with Knee Pain Chronic and Synovitis of Knee, run by The Hong Kong Polytechnic University at 2 sites in 2 countries.
Trial summary
Background: Knee pain is a common complaint among middle-aged and older adults, often leading to reduced mobility and diminished quality of life. Synovitis is a major underlying cause, present in up to 80% of individuals with moderate knee pain. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Pain Chronic, Synovitis of Knee, Light Therapy
- What is being tested?
- 810 nm Light Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 13 Jul 2025to 28 May 2026
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged between 40 and 80 years
- Able to provide written informed consent
- Have experienced knee pain that persists or recurs for more than 3 months
- A knee pain score of at least 30 mm on the 100-mm Visual Analogue Scale (VAS) during the past week
- Ultrasound-measured knee synovitis ≥1
- Presence of knee OA according to criteria established by the American College of Rheumatology
Who cannot join
- Anticipated need for knee surgery within the next one year
- Previous or planned knee replacement within the next one year
- Knee surgery or other physical therapy in the previous 3 months
- Use of intra-articular, intra-muscular, or oral corticosteroids in previous 4 weeks
- Malignant tumors or other life-threatening diseases
- Severe mental disorders, including but not limited to schizophrenia, bipolar disorder, or major depressive disorder, that may interfere with the participant's ability to comply with the study protocol or provide informed consent
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
China1 site, 1 recruiting
- Recruiting
Buji Community Service Center, Longgang District
Shenzhen
Tianxiang Fan, 86 15750867202, tianxiang.fan@connect.polyu.hk
Hong Kong1 site, 1 recruiting
- Not yet recruiting
The Hong Kong Polytechnic University
Hong Kong
Tianxiang Fan, 852 68411557, tianxiang.fan@connect.polyu.hk
About this study
Official title: Effect of Light Therapy on Pain and Synovitis in Patients With Knee Synovitis: Study Protocol for a Randomized Controlled Trial
Background: Knee pain is a common complaint among middle-aged and older adults, often leading to reduced mobility and diminished quality of life. Synovitis is a major underlying cause, present in up to 80% of individuals with moderate knee pain. While light therapy has shown anti-inflammatory and analgesic effects in preclinical studies, our prior animal experiments revealed that light therapy at 810 nm significantly alleviated inflammation and pain-like behaviors. These findings suggest a potential wavelength-specific therapeutic effects. However, it remains unclear whether such effects can be replicated in humans. This study aims to evaluate the efficacy of 810 nm light therapy, compared to sham treatment, in reducing knee pain and synovitis in patients with chronic knee pain and knee synovitis.
Methods/design:
Read more
This is a randomized, placebo-controlled clinical trial involving 90 participants with chronic knee pain and ultrasound-detected synovitis. Participants will be randomized into two groups to receive 810 nm light therapy, or sham therapy, delivered twice weekly over five weeks. Primary outcomes include knee pain assessed by the Visual Analogue Scale (VAS) and synovitis assessed by ultrasound. Secondary outcomes include the Knee injury and Osteoarthritis Outcome Score (KOOS), the 30-second chair stand test, and the 40-meter fast-paced walk test. Outcome assessments will be performed at baseline, post-intervention (week 5), and at 1 month and 6 months after treatment completion. Linear mixed-effects models will be used to compare outcome changes between groups.
Discussion:
This trial will assess whether 810 nm light therapy provides clinically meaningful benefits for reducing knee pain and synovitis in humans, building on promising preclinical findings. Results from this study may support the use of near-infrared light as a safe, non-invasive, and effective intervention for synovitis-related knee pain.
- Conditions
- Knee Pain Chronic, Synovitis of Knee, Light Therapy
- Being tested
- 810 nm Light Therapy, Sham Light Therapy
- Keywords
- Light therapy, Photobiomodulation, Chronic knee pain, Synovitis, Randomized controlled trial, Non-pharmacological intervention, physical therapy
- Medical subject headings
- Synovitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
810 nm Light TherapyDevice
Light therapy at 810 nm, 39 J/cm², delivered via wearable device.
Sham Light TherapyDevice
Identical device, no light output, delivered via wearable device.
| Study group | Role | What they receive |
|---|---|---|
| 810 nm Light Therapy Group | Experimental | Participants receive 810 nm light therapy using a wearable device, twice per week for 5 weeks. Receives: Device: 810 nm Light Therapy |
| Sham Therapy Group | Placebo comparator | Participants receive sham therapy with the same device that emits no therapeutic light, twice per week for 5 weeks. Receives: Device: Sham Light Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee pain (Visual Analogue Scale, VAS)
Knee pain severity will be assessed using a 100-mm Visual Analogue Scale (VAS), based on average pain over the past week.
Measured: Baseline, Week 5, 1-month follow-up, 6-month follow-up
Knee synovitis grade (Ultrasound assessment)
Knee ultrasound will be performed by an ultrasound physician with over 8 years of experience, following the published protocol (Bruyn GAW, Naredo E, Damjanov N, et al (2016) An OMERACT reliability exercise of inflammatory and structural abnormalities in patients with knee osteoarthritis using ultrasound assessment. Ann Rheum Dis 75:842-846. https://doi.org/10.1136/ann). The items measured included the maximal score for synovitis obtained at the suprapatellar or parapatellar recesses, with a range of 0-3. Grade 0 indicates no synovitis; Grade 1 represents minimal distension of the recess by abnormal internal hypoechoic or anechoic material (relative to subdermal fat tissue); Grade 2 signifies moderate distension or enlargement of the recess by abnormal internal hypoechoic or anechoic material with a flat or concave superficial limit; and Grade 3 denotes severe distension or enlargement of the recess by abnormal internal hypoechoic or anechoic material with a bulging superficial limit.
Measured: Baseline, Week 5, 1-month follow-up, 6-month follow-up
Secondary outcomes (4)
Knee Injury and Osteoarthritis Score (KOOS)
Knee Injury and Osteoarthritis Score (KOOS) that includes subdomains of pain (9 items), other symptoms (7 items), function and daily living (short PS version 7 items), and knee-related quality of life (4 items) will be used in this study. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
Measured: Baseline, Week 5, 1-month follow-up, 6-month follow-up
Lower limb function (30-second chair stand test)
A standard chair without arms will be used for the chair stand test (Dobson F, Bennell KL, Hinman RS, et al (2013) Recommended performance based tests to assess physical function in patients with hip/knee OA. Osteoarthr Cartil 8:1042-52). Participants will begin the test seated with their arms crossed over their chest. They will be instructed to stand up fully, so hips and knees are fully extended, and return to the seated position as many times as possible within 30 seconds, while keeping their arms crossed. The total number of chair stands (up and down equals one stand) completed in 30 seconds will be recorded. If a full stand has been completed at 30 seconds (i.e. standing fully erect or on the way down to the sitting position), then this final stand is counted in the total.
Measured: Baseline, Week 5, 1-month follow-up, 6-month follow-up
Walking speed (40-meter fast-paced walk test)
The 40-meter walk test will be conducted on a marked 10-meter walkway, with cones placed 2 meters beyond each end to facilitate turning. Participants wore comfortable walking footwear. After a brief practice trial to ensure understanding, participants will be instructed to walk as quickly and safely as possible, without running, along the walkway. They turned around the cones at each end and repeated the process until completing a total distance of 40 meters, involving three turns. Timing started when participants began walking and stopped when they crossed the start line after completing the full distance. Walking speed (m/s) will be calculated by dividing 40 meters by the recorded time (Dobson F, Bennell KL, Hinman RS, et al (2013) Recommended performance based tests to assess physical function in patients with hip/knee OA. Osteoarthr Cartil 8:1042-52).
Measured: Baseline, Week 5, 1-month follow-up, 6-month follow-up
Adverse events monitoring for light therapy
Participants will be closely monitored for adverse events (AEs) at each treatment and visit throughout the study. If any AEs occur (e.g., cutaneous irritation, redness, or itching at the treatment site), they will be documented on a separate form and reported to the principal investigators (PIs) within 24 hours. This monitoring will ensure that any adverse events are promptly addressed and that the safety of participants is prioritized throughout the study.
Measured: Throughout the intervention period and at all follow-up visits (up to 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start13 Jul 2025
- Primary completion28 May 2026 (estimated)
- Study completion28 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee Pain ChronicStudies of the same condition, open and under way.
- 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
- randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FU Siu Ngor, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057063
- Sponsor's protocol ID
- HSEARS20230214003 PolyU
- Status last verified
- Nov 2025
- First submitted
- 25 Jun 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie the results reported in this article, after de-identification, will be shared. Data will be available upon reasonable request from qualified researchers, subject to ethics approval and data use agreement. The data will become available after the publication of the main results and will be accessible for a period of 5 years.
Publications
1. Duong V, Oo WM, Ding C, et al (2023) Evaluation and Treatment of Knee Pain: A Review. Jama 330:1568-1580. https://doi.org/10.1001/jama.2023.19675 2. Baker K, Grainger A, Niu J, et al (2010) Relation of synovitis to knee pain using contrast-enhanced MRIs. Ann Rheum Dis 69:1779-83. https://doi.org/10.1136/ard.2009.121426 3. Blom AB, van Lent PLEM, Holthuysen AEM, et al (2004) Synovial lining macrophages mediate osteophyte formation during experimental osteoarthritis. Osteoarthr Cartil 12:627-35. https://doi.org/10.1016/j.joca.2004.03.003 4. Mathiessen A, Conaghan PG (2017) Synovitis in osteoarthritis: Current understanding with therapeutic implications. Arthritis Res Ther 19:1-9. https://doi.org/10.1186/s13075-017-1229-9 5. Zhu Z, Li J, Ruan G, et al (2018) Investigational drugs for the treatment of osteoarthritis, an update on recent developments. Expert Opin Investig Drugs 27:881-900. https://doi.org/10.1080/13543784.2018.1539075 6. Mussttaf RA, Jenkins DFL, Jha AN (2019) Assessing the impact of low level laser therapy (LLLT) on biological systems: a review. Int J Radiat Biol 95:120-143. https://doi.org/10.1080/09553002.2019.1524944 7. de Freitas LF, Hamblin MR (2016) Proposed Mechanisms of Photobiomodulation or Low-Level Light Therapy. IEEE J Sel Top Quantum Electron 22:. https://doi.org/10.1109/JSTQE.2016.2561201 8. de Oliveira VLC, Silva JA, Serra AJ, et al (2017) Photobiomodulation therapy in the modulation of inflammatory mediators and bradykinin receptors in an experimental model of acute osteoarthritis. Lasers Med Sci 32:87-94. https://doi.org/10.1007/s10103-016-2089-2 9. Hagiwara S, Iwasaka H, Okuda K, Noguchi T (2007) GaAlAs (830 nm) low-level laser enhances peripheral endogenous opioid analgesia in rats. Lasers Surg Med 39:797-802. https://doi.org/10.1002/lsm.20583 10. dos Santos SA, dos Santos Vieira MA, Simões MCB, et al (2017) Photobiomodulation therapy associated with treadmill training in the oxidative stress in a collagen-induced arthrit
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Light Therapy on Pain and Synovitis in Patients With Knee Synovitis: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07057063
- Acronym / sponsor ID
- HSEARS20230214003 PolyU
- Conditions
- Knee Pain Chronic, Synovitis of Knee, Light Therapy
- Keywords
- Light therapy, Photobiomodulation, Chronic knee pain, Synovitis, Randomized controlled trial, Non-pharmacological intervention, physical therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 13 Jul 2025 (actual)
- Primary completion
- 28 May 2026 (estimated)
- Study completion
- 28 May 2026 (estimated)
- First posted
- 9 Jul 2025 (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.
Background: Knee pain is a common complaint among middle-aged and older adults, often leading to reduced mobility and diminished quality of life. Synovitis is a major underlying cause, present in up to 80% of individuals with moderate knee pain. While light therapy has shown anti-inflammatory and analgesic effects in preclinical studies, our prior animal experiments revealed that light therapy at 810 nm significantly alleviated inflammation and pain-like behaviors. These findings suggest a potential wavelength-specific therapeutic effects. However, it remains unclear whether such effects can be replicated in humans. This study aims to evaluate the efficacy of 810 nm light therapy, compared to sham treatment, in reducing knee pain and synovitis in patients with chronic knee pain and knee synovitis.
Methods/design:
This is a randomized, placebo-controlled clinical trial involving 90 participants with chronic knee pain and ultrasound-detected synovitis. Participants will be randomized into two groups to receive 810 nm light therapy, or sham therapy, delivered twice weekly over five weeks. Primary outcomes include knee pain assessed by the Visual Analogue Scale (VAS) and synovitis assessed by ultrasound. Secondary outcomes include the Knee injury and Osteoarthritis Outcome Score (KOOS), the 30-second chair stand test, and the 40-meter fast-paced walk test. Outcome assessments will be performed at baseline, post-intervention (week 5), and at 1 month and 6 months after treatment completion. Linear mixed-effects models will be used to compare outcome changes between groups.
Discussion:
This trial will assess whether 810 nm light therapy provides clinically meaningful benefits for reducing knee pain and synovitis in humans, building on promising preclinical findings. Results from this study may support the use of near-infrared light as a safe, non-invasive, and effective intervention for synovitis-related knee pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| 810 nm Light Therapy Group | Experimental | Device: 810 nm Light TherapyParticipants receive 810 nm light therapy using a wearable device, twice per week for 5 weeks. |
| Sham Therapy Group | Placebo comparator | Device: Sham Light TherapyParticipants receive sham therapy with the same device that emits no therapeutic light, twice per week for 5 weeks. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants aged between 40 and 80 years
- Able to provide written informed consent
- Have experienced knee pain that persists or recurs for more than 3 months
- A knee pain score of at least 30 mm on the 100-mm Visual Analogue Scale (VAS) during the past week
- Ultrasound-measured knee synovitis ≥1
Key exclusion criteria (6 listed)
- Anticipated need for knee surgery within the next one year
- Previous or planned knee replacement within the next one year
- Knee surgery or other physical therapy in the previous 3 months
- Use of intra-articular, intra-muscular, or oral corticosteroids in previous 4 weeks
- Malignant tumors or other life-threatening diseases
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 |
|---|---|---|
| 810 nm Light TherapyLight therapy at 810 nm, 39 J/cm², delivered via wearable device. | Device | 810 nm Light Therapy Group |
| Sham Light TherapyIdentical device, no light output, delivered via wearable device. | Device | Sham Therapy Group |
Primary outcome
Knee pain (Visual Analogue Scale, VAS)
Time frame: Baseline, Week 5, 1-month follow-up, 6-month follow-up
Knee pain severity will be assessed using a 100-mm Visual Analogue Scale (VAS), based on average pain over the past week.
Knee synovitis grade (Ultrasound assessment)
Time frame: Baseline, Week 5, 1-month follow-up, 6-month follow-up
Knee ultrasound will be performed by an ultrasound physician with over 8 years of experience, following the published protocol (Bruyn GAW, Naredo E, Damjanov N, et al (2016) An OMERACT reliability exercise of inflammatory and structural abnormalities in patients with knee osteoarthritis using ultrasound assessment. Ann Rheum Dis 75:842-846. https://doi.org/10.1136/ann). The items measured included the maximal score for synovitis obtained at the suprapatellar or parapatellar recesses, with a range of 0-3. Grade 0 indicates no synovitis; Grade 1 represents minimal distension of the recess by abnormal internal hypoechoic or anechoic material (relative to subdermal fat tissue); Grade 2 signifies moderate distension or enlargement of the recess by abnormal internal hypoechoic or anechoic material with a flat or concave superficial limit; and Grade 3 denotes severe distension or enlargement of the recess by abnormal internal hypoechoic or anechoic material with a bulging superficial limit.
4 secondary outcomes
Knee Injury and Osteoarthritis Score (KOOS)
Time frame: Baseline, Week 5, 1-month follow-up, 6-month follow-up
Lower limb function (30-second chair stand test)
Time frame: Baseline, Week 5, 1-month follow-up, 6-month follow-up
Walking speed (40-meter fast-paced walk test)
Time frame: Baseline, Week 5, 1-month follow-up, 6-month follow-up
Adverse events monitoring for light therapy
Time frame: Throughout the intervention period and at all follow-up visits (up to 6 months)
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 26 Nov 2025.
- Background1. Duong V, Oo WM, Ding C, et al (2023) Evaluation and Treatment of Knee Pain: A Review. Jama 330:1568-1580. https://doi.org/10.1001/jama.2023.19675 2. Baker K, Grainger A, Niu J, et al (2010) Relation of synovitis to knee pain using contrast-enhanced MRIs. Ann Rheum Dis 69:1779-83. https://doi.org/10.1136/ard.2009.121426 3. Blom AB, van Lent PLEM, Holthuysen AEM, et al (2004) Synovial lining macrophages mediate osteophyte formation during experimental osteoarthritis. Osteoarthr Cartil 12:627-35. https://doi.org/10.1016/j.joca.2004.03.003 4. Mathiessen A, Conaghan PG (2017) Synovitis in osteoarthritis: Current understanding with therapeutic implications. Arthritis Res Ther 19:1-9. https://doi.org/10.1186/s13075-017-1229-9 5. Zhu Z, Li J, Ruan G, et al (2018) Investigational drugs for the treatment of osteoarthritis, an update on recent developments. Expert Opin Investig Drugs 27:881-900. https://doi.org/10.1080/13543784.2018.1539075 6. Mussttaf RA, Jenkins DFL, Jha AN (2019) Assessing the impact of low level laser therapy (LLLT) on biological systems: a review. Int J Radiat Biol 95:120-143. https://doi.org/10.1080/09553002.2019.1524944 7. de Freitas LF, Hamblin MR (2016) Proposed Mechanisms of Photobiomodulation or Low-Level Light Therapy. IEEE J Sel Top Quantum Electron 22:. https://doi.org/10.1109/JSTQE.2016.2561201 8. de Oliveira VLC, Silva JA, Serra AJ, et al (2017) Photobiomodulation therapy in the modulation of inflammatory mediators and bradykinin receptors in an experimental model of acute osteoarthritis. Lasers Med Sci 32:87-94. https://doi.org/10.1007/s10103-016-2089-2 9. Hagiwara S, Iwasaka H, Okuda K, Noguchi T (2007) GaAlAs (830 nm) low-level laser enhances peripheral endogenous opioid analgesia in rats. Lasers Surg Med 39:797-802. https://doi.org/10.1002/lsm.20583 10. dos Santos SA, dos Santos Vieira MA, Simões MCB, et al (2017) Photobiomodulation therapy associated with treadmill training in the oxidative stress in a collagen-induced arthrit
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie the results reported in this article, after de-identification, will be shared. Data will be available upon reasonable request from qualified researchers, subject to ethics approval and data use agreement. The data will become available after the publication of the main results and will be accessible for a period of 5 years.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 810 nm Light Therapy in people with Knee Pain Chronic and Synovitis of Knee, run by The Hong Kong Polytechnic University at 2 sites in 2 countries.
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 6 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: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China, Hong Kong. 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?
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?
Contact Tianxiang Fan, PhD candidate (+85268411557, tianxiang.fan@connect.polyu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee pain (Visual Analogue Scale, VAS) (time frame: Baseline, Week 5, 1-month follow-up, 6-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07057063, which also lists 1 linked publication.
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 26 Nov 2025.