810 nm light therapy for chronic knee pain and synovitis
Effect of Light Therapy on Pain and Synovitis in Patients With Knee Synovitis: Study Protocol for a Randomized Controlled Trial
This trial will test whether 810 nm light therapy can reduce pain and knee inflammation in adults aged 40–80 with chronic knee pain and ultrasound-confirmed synovitis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | The Hong Kong Polytechnic University Academic / other |
| Locations | 2 sites (Shenzhen and 1 other locations) |
| Trial ID | NCT07057063 on ClinicalTrials.gov |
What this trial studies
This is a randomized, placebo-controlled trial that will enroll 90 adults with chronic knee pain, ACR-defined knee osteoarthritis, and ultrasound-detected synovitis, randomizing them to 810 nm light therapy or a sham treatment. The intervention targets photobiomodulation at a wavelength that showed strong anti-inflammatory and analgesic effects in prior animal experiments. Key outcomes include change in pain measured by the 100-mm VAS and change in synovitis severity on ultrasound. The goal is to determine whether the wavelength-specific benefits seen in preclinical work translate into meaningful clinical improvement in humans.
Who should consider this trial
Good fit: Adults aged 40–80 with knee pain lasting more than 3 months, a recent VAS pain score ≥30 mm, ultrasound synovitis ≥1, and meeting ACR criteria for knee OA are ideal candidates.
Not a fit: Patients expecting knee surgery in the next year, with recent corticosteroid use, recent knee surgery/physical therapy, active malignancy, or severe psychiatric disorders are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this noninvasive light therapy could reduce knee pain and joint inflammation, improving mobility and quality of life.
How similar studies have performed: Preclinical animal studies reported clear pain- and inflammation-reducing effects at 810 nm, but human trials of photobiomodulation for knee pain have been limited and have produced mixed results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Shenzhen and 1 other locations
- Buji Community Service Center, Longgang District — Shenzhen, China (Recruiting)
- The Hong Kong Polytechnic University — Hong Kong, Hong Kong (Not_yet_recruiting)
Study contacts
- Study coordinator: Tianxiang Fan, PhD candidate
- Email: tianxiang.fan@connect.polyu.hk
- Phone: +85268411557
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.