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Идёт набор NCT07057063

Light Therapy on Pain and Synovitis

Без фазы С лечением Knee Pain Chronic Synovitis of Knee Light Therapy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: 810 nm Light Therapy, Sham Light Therapy.
Кому может быть актуально
Состояния в реестре: Knee Pain Chronic, Synovitis of Knee, Light Therapy. Базовые параметры: 40 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай, Гонконг
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Устройство 810 nm Light Therapy
    Light therapy at 810 nm, 39 J/cm², delivered via wearable device.
  • Устройство Sham Light Therapy
    Identical device, no light output, delivered via wearable device.

Первичные конечные точки

  • Knee pain (Visual Analogue Scale, VAS) [Срок оценки: Baseline, Week 5, 1-month follow-up, 6-month follow-up]
  • Knee synovitis grade (Ultrasound assessment) [Срок оценки: Baseline, Week 5, 1-month follow-up, 6-month follow-up]
Вторичные конечные точки (4)
  • Knee Injury and Osteoarthritis Score (KOOS) [Срок оценки: Baseline, Week 5, 1-month follow-up, 6-month follow-up]
  • Lower limb function (30-second chair stand test) [Срок оценки: Baseline, Week 5, 1-month follow-up, 6-month follow-up]
  • Walking speed (40-meter fast-paced walk test) [Срок оценки: Baseline, Week 5, 1-month follow-up, 6-month follow-up]
  • Adverse events monitoring for light therapy [Срок оценки: Throughout the intervention period and at all follow-up visits (up to 6 months)]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Buji Community Service Center, Longgang District — Шэньчжэнь
Гонконг · 1 центр
  • The Hong Kong Polytechnic University — Гонконг

Публикации

  • 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

Идентификаторы

NCT: NCT07057063 · HSEARS20230214003 PolyU

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗