NCT02696083已完成不适用
A Multicenter, Open-Label, Single-Arm, Proof of Concept Study of Pulsed Electromagnetic Field (PEMF) Therapy to Evaluate Synovial Fluid Markers in Subjects With Osteoarthritis of the Knee
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 4
- 主要终点
- Number of Synovial Markers Showing a Reduction From Baseline Following Treatment at Days 45 and 90
研究概览
简要总结
To investigate the effect of PEMF treatment when administered twice daily over a 90-day period by looking at synovial fluid in subjects with osteoarthritis of the knee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject age is greater than or equal to 45 years and less than 80 years of age.
- •Subject has documented Kellgren-Lawrence radiograph score of 2, 3, or
- •Attempts will be made to include at least 3 subjects in each category.
- •Subject is on a stable analgesic regimen for at least two weeks prior to the Screening Visit and anticipates being able to remain on that regimen throughout the study.
- •Subject is willing and able to give written informed consent and to comply with all parts of the study protocol.
- •Female subjects must be post-menopausal, surgically sterile, abstinent, or practicing (or agree to practice) an effective method of birth control if they are sexually active for the duration of the study. (Effective methods of birth control include prescription hormonal contraceptives, intrauterine devices, double-barrier methods, and/or male partner sterilization).
排除标准
- •Subject has documented Kellgren-Lawrence radiograph score of
- •Subject has undergone viscosupplementation treatment for the knee within 2 months of the Screening Visit.
- •Subject has had a total or partial knee replacement.
- •Subject has used topical or oral steroids within 2 months of the Screening Visit.
- •Subject has undergone any anesthetic injection into the knee within 30 days prior to the Screening Visit or within 6 weeks prior to the Screening Visit for long acting lidocaine injection products.
- •Subject has other diseases of the knee joint including inflammatory arthritis (i.e., rheumatoid arthritis, spondyloarthritis, gout and pseudogout), autoimmune disease (i.e., connective tissue disorders), septic arthritis, previous knee injury or intra-articular fracture.
- •Subject will be unable to treat daily over the course of the 90 day treatment period (e.g., travelling without the ability to take Provant).
- •Subject has received any investigational drug or device within 30 days or 5 half-lives of the drug, whichever is longer, prior to the Screening Visit or is enrolled in another clinical trial.
- •Subject has a history of a solid tumor that is not in complete remission for greater than 2 years other than successfully treated non-metastatic basal cell or squamous cell carcinomas of the skin in the treatment area.
- •Subject has a history of blood cancer (e.g., leukemia, lymphoma, multiple myeloma).
- •Subject has an ongoing painful condition, other than osteoarthritis, that in the opinion of the investigator might have a confounding influence on the safety or effectiveness analyses for this study.
- •Subject has a Body Mass Index (BMI) > 38 kg/m
- •Subject has a serious psychosocial co-morbidity.
- •Subject has a history of drug or alcohol abuse within one year prior to screening.
- •Subject has an implanted pacemaker, defibrillator, neurostimulator, spinal cord stimulator, bone stimulator, cochlear implant, or other implanted device with an implanted metal lead(s).
- •Subject is currently pregnant or planning on becoming pregnant prior to Day
- •Subject is unwilling or unable to follow study instructions, or comply with the treatment regimen, study visits, and diary entries.
- •Subject is in current litigation regarding knee pain or is receiving Worker's Compensation.
结局指标
主要结局
Number of Synovial Markers Showing a Reduction From Baseline Following Treatment at Days 45 and 90
时间窗: Baseline, Days 45 and 90
Synovial markers measured included bone morphologic proteins, related proteins Activin A, Osteoactivin, sonic hedgehog, Dickkopf, interleukin cytokines and tumor necrosis factor alpha, Growth Factors and Related Proteins fibroblast growth factors 1,2, androgen receptor, platelet derived growth factor BB, tumor growth factor beta, osteprogenerin, osteopontin, and Insulin like growth factor-1. Inflammation related proteins assayed were monocyte chemoattractant protein-1, macrophage colony-stimulating factor, macrophage inflammatory protein, receptor activator of Nuclear factor κ, and TNF related activation induced cytokine. Adhesion and matrix metalloproteinase proteins levels were also determined. The mean protein concentration was calculated for these markers at Baseline (n=19), Day 45 (n=7) and Day 90 (n=6).
次要结局
未报告次要终点
研究者
研究点 (4)
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