Light Therapy on Pain and Synovitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 810 nm Light Therapy, Sham Light Therapy.
- Who it may be relevant to
- Registry conditions: Knee Pain Chronic, Synovitis of Knee, Light Therapy. Basic parameters: 40 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China, Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of Light Therapy on Pain and Synovitis in Patients With Knee Synovitis: Study Protocol for a Randomized Controlled Trial
Overview
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.
Interventions
- Device 810 nm Light Therapy
Light therapy at 810 nm, 39 J/cm², delivered via wearable device. - Device Sham Light Therapy
Identical device, no light output, delivered via wearable device.
Primary outcome measures
- Knee pain (Visual Analogue Scale, VAS) [Time frame: Baseline, Week 5, 1-month follow-up, 6-month follow-up]
- Knee synovitis grade (Ultrasound assessment) [Time frame: Baseline, Week 5, 1-month follow-up, 6-month follow-up]
Secondary outcome measures (4)
- 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)]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Buji Community Service Center, Longgang District — Shenzhen
Hong Kong · 1 center
- The Hong Kong Polytechnic University — Hong Kong
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 macr
Identifiers
NCT: NCT07057063 · HSEARS20230214003 PolyU