RecruitingNot ApplicableNCT07057063

Light Therapy on Pain and Synovitis

Effect of Light Therapy on Pain and Synovitis in Patients With Knee Synovitis: Study Protocol for a Randomized Controlled Trial


Sponsor

The Hong Kong Polytechnic University

Enrollment

80 participants

Start Date

Jul 13, 2025

Study Type

INTERVENTIONAL

Conditions

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. 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.


Eligibility

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called 810 nm Light Therapy and a medical device called Sham Light Therapy for people with knee pain chronic, light therapy, and other related conditions. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICE810 nm Light Therapy

Light therapy at 810 nm, 39 J/cm², delivered via wearable device.

DEVICESham Light Therapy

Identical device, no light output, delivered via wearable device.


Locations(2)

Buji Community Service Center, Longgang District

Shenzhen, China

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

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NCT07057063


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