A Pilot Trial to Assess Low-Intensity Ultrasound in Osteoarthritis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 6
- 主要终点
- Co-Primary Measure: a) Symptom Reduction: OMERACT-OARSI Treatment Responsiveness
研究概览
简要总结
The purpose of this exploratory trial is to investigate whether PLIUS is potentially effective as a disease and symptom modifying intervention in patients with early knee OA.
详细描述
Osteoarthritis (OA), the most common form of arthritis, is a prevalent and debilitating disease without therapies that alter disease progress and is currently managed with symptom-modifying therapies that are only modestly effective. In spite of substantial progress in understanding the pathogenesis of OA, no effective disease modifying interventions have been established. Degenerative joint cartilage is a central feature of OA, yet joint cartilage has a limited capacity for repair. Results from animal research demonstrate that pulsed low intensity ultrasound (PLIUS) mechanically stimulates, and may promote, cartilage repair. This exploratory trial will investigate whether PLIUS is potentially effective as a disease and symptom modifying intervention in patients with early knee OA.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40 years of age or older, and a US Military Veteran
- •Clinical symptoms of osteoarthritis for at least 6 months
- •Pain in the index knee on motion or weight bearing for the majority of days during the month before screening
- •Clinical diagnosis of primary osteoarthritis of the knee based on clinical and radiographic criteria
- •American Rheumatism Association Functional Class I, II, or III
- •Females of childbearing potential must be willing to use a reliable form of medically acceptable contraception
排除标准
- •Concurrent medical/arthritis condition(s), or any other illness per the opinion of the investigator, that could interfere with the evaluation of pain or efficacy
- •Spine or hip pain of significant magnitude
- •History of significant ligament or meniscal injury of the index joint requiring surgical repair
- •Arthroscopy of the index knee within 6 months of study entry
- •Unable to undergo MRI of the knee
- •Pregnancy or lactation
- •Corticosteroid treatment within 1 to 3 months prior to study entry
- •Intra-articular injection of hyaluronic acid or congeners to the index knee within 6 months of study entry
- •Use of excluded therapy(ies) prior to study entry
- •Use of disease modifying anti-rheumatic medications and chronic tetracycline or its derivatives
- •Exposure to glucosamine, chondroitin sulfate, or any other investigational treatment, within 1 month of study entry
- •Use of any medical therapy, complementary or alternative regimens for the treatment of osteoarthritis within 7 days prior to study entry
- •Initiation of physical therapy or muscle conditioning program to the lower extremities within 2 months within 2 months prior to study entry
- •Unlikely to comply with study requirements
结局指标
主要结局
Co-Primary Measure: a) Symptom Reduction: OMERACT-OARSI Treatment Responsiveness
时间窗: 48 weeks
Outcome Measures in Rheumatology Clinical Trials- Osteoarthritis Research Society International (OMERACT-OARSI) Response incorporates changes in pain and global assessment to define response in OA clinical trials. A response is classified as: 1) An improvement in either pain or function of at least 50 percent accompanied by an absolute decrease of at least 20 mm on the visual-analogue scale for pain or function, OR 2) The occurrence of at least two of the following: a) a decrease in pain of at least 20 percent accompanied by a decrease of at least 10 mm on the visual-analogue scale; b) an improvement in function of at least 20 percent and a decrease of at least 10 mm on the visual-analogue scale; c) an increase in the patient's global assessment score by at least 20 percent accompanied by a decrease of at least 10 mm on the visual-analogue scale
Co-Primary Measure: b) Disease Modification as Measured by Change From Baseline in Cartilage Thickness of the Central Medial Femoral Condyle Disease
时间窗: Baseline, 48 weeks
The study has been designed to determine if PLIUS potentially diminishes articular cartilage thinning by measuring cartilage thickness in the tibial femoral joint. The measure selected to best evaluate this is cartilage thickness of the central medial femoral condyle because studies of the OAI (Osteoarthritis Initiative) data have shown this region to be among those most sensitive to change and, due to the anatomical positioning of the device, the most likely to be affected by treatment.
次要结局
- Change From Baseline in WOMAC Pain Subscale Score(Baseline, week 24, week 48)
- Change From Baseline in WOMAC Functional Limits Subscale Score(Baseline, week 24, week 48)
- Change From Baseline in Patient Global Assessment of Disease Status(Baseline, week 24, week 48)
- Number of Participants Discontinuing the Study Device Due to an Adverse Device Event(Baseline, 4, 8, 12, 24, 36, and 48-week visits)
- Change From Baseline in WOMAC Stiffness Subscale Score(Baseline, week 24, week 48)
- Change From Baseline in Total WOMAC Score(Baseline, week 24, week 48)
- Change From Baseline in Investigator Global Assessment of Disease Status(Baseline, week 24, week 48)
- Change From Baseline in Intermittent and Constant Osteoarthritis Pain (ICOAP) Total Pain Score(Baseline, week 24, week 48)
- Change From Baseline in Intermittent and Constant Osteoarthritis Pain (ICOAP) Constant Pain Subscale(Baseline, week 24, week 48)
- Change From Baseline in Intermittent and Constant Osteoarthritis Pain (ICOAP) Intermittent Pain Subscale(Baseline, week 24, week 48)