Effect of Light Therapy on Pain and Synovitis in Patients With Knee Synovitis: Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Knee pain (Visual Analogue Scale, VAS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Allocation will be not revealed to the participants and ultrasound assessors until the completion of the final data analyses.
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Knee pain (Visual Analogue Scale, VAS)
时间窗: 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)
时间窗: 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.
次要结局
- Knee Injury and Osteoarthritis Score (KOOS)(Baseline, Week 5, 1-month follow-up, 6-month follow-up)
- Adverse events monitoring for light therapy(Throughout the intervention period and at all follow-up visits (up to 6 months))
- Lower limb function (30-second chair stand test)(Baseline, Week 5, 1-month follow-up, 6-month follow-up)
- Walking speed (40-meter fast-paced walk test)(Baseline, Week 5, 1-month follow-up, 6-month follow-up)
- Knee Injury and Osteoarthritis Score (KOOS)(Baseline, Week 5, 1-month follow-up, 6-month follow-up)
- Lower limb function (30-second chair stand test)(Baseline, Week 5, 1-month follow-up, 6-month follow-up)
- Walking speed (40-meter fast-paced walk test)(Baseline, Week 5, 1-month follow-up, 6-month follow-up)
- Adverse events monitoring for light therapy(Throughout the intervention period and at all follow-up visits (up to 6 months))
研究者
FU Siu Ngor
Peter Hung Professor in Pain Management, Assoc. Head(RS), ADoRISports & Professor
The Hong Kong Polytechnic University