NCT04367597已完成不适用
A Roll-over Study of CM-2019 Trial (A Randomized, Sham Controlled, Double-blind, Multi-center Study of Neuromuscular Electrical Stimulation (NMES) as an Adjunctive Therapy for Knee Pain Relief and Improving Functional Outcomes in Knee Osteoarthritis (OA) Patients)
CyMedica Orthopedics, Inc8 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2020年4月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 8
- 主要终点
- Knee pain
研究概览
简要总结
A roll-over study of the current CM-2019 trial to assess the same preplanned outcomes of CM-2019 at 14 weeks.
详细描述
This roll-over study is designed as a 14-week treatment continuation from CM-2019 (parent study), a randomized, sham controlled, double-blind, multi-center study trial to evaluate the efficacy of CyMedica Orthopedics e-vive™ system, a multifunctional electrotherapy device providing neuromuscular electrical stimulation (NMES) as an adjunctive therapy for pain relief and accelerating functional recovery in patients with knee osteoarthritis. This follow-up trial will include subjects who have been randomized into the CM-2019 trial. Subjects will be enrolled into the appropriate treatment group based upon the treatment received in the parent study. It is hypothesized that the continued use of CyMedica e-vive NMES may provide additional pain relief and improved knee function for an additional 14 weeks compared to sham.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must provide a signed informed consent for CM-2019R. The subject will be provided with a copy of the signed Informed Consent upon signature.
- •Currently enrolled in the parent trial CM-2019 or have successfully completed the parent trial within 21 days of enrollment in the roll-over trial.
- •Willing and able to continue parent trial study treatment.
- •Pregnancy test, if it has been >14 days since completion of the parent trial.
- •Subject must continue to be willing to refrain from receiving knee intra-articular injections of steroids, knee intra-articular injections of hyaluronic acid, opioids, and analgesics (except for acetaminophen up to 3000 mg/day or an equivalent) for the duration of the study.
- •Subject must continue to be willing to take acetaminophen (up to 3000 mg/day) or an equivalent as pain medication for the duration of the study.
- •Subject must continue to be willing to stop taking any pain medications 24 hours prior any scheduled study visit.
- •Subject must continue to be willing to stop receiving knee physical therapy of the target knee for the duration of the study.
- •Subject must continue be willing to stop wearing any knee unloader brace of the target knee for the duration of the study.
- •Subjects must be willing and able to comply with all study procedures for the duration of the clinical study
排除标准
- •Subjects with a new diagnosis of inflammatory arthritis (knee rheumatoid arthritis, active gout, knee joint infection, Lyme disease, SLE, etc.) since parent trial enrollment.
- •Subjects with a new diagnosis of severe neuropathy condition and under medication for treatment of the condition since parent trial enrollment.
- •Subjects with a new diagnosis of fibromyalgia since parent trial enrollment.
- •Subjects who have had an injury or an acute traumatic injury to the target knee since parent trial enrollment.
- •Subject must NOT have had arthroscopy of the target knee since parent trial enrollment.
- •Subjects who have had treatment of the target knee with intra-articular injections of steroids since parent trial enrollment. Subjects who have had intra-articular injections of hyaluronic acid since parent trial enrollment.
- •Subjects who have a scheduled surgery on the target knee within the study period. (Subjects that are contemplating the surgery can be included.)
- •Subjects who have used electrotherapy or acupuncture for OA of the target knee since parent trial enrollment year.
- •Subjects who have had implanted electrical devices since parent trial enrollment (cardiac pacemakers, deep brain stimulators, implantable cardiac defibrillators).
- •Subjects with a current new malignancy or who have received treatment for malignancy since parent trial enrollment, with the exception of resected basal cell carcinoma and squamous cell carcinoma of the skin.
- •Subjects with a new skin breakdown or infection in the area where the study device will be placed (quadriceps of the target knee).
- •Subjects with any newly reported chronic conditions (e.g., diabetes, hypertension, congestive heart failure, etc.) or that have not been well-controlled during the parent trial.
- •Subjects who have any new litigation for worker's compensation.
- •Subjects with any new condition, in the opinion of the Investigator that might interfere with the evaluation of the study objectives.
- •Subjects who are pregnant.
- •Subject who enrolled in any new clinical study from the last day of treatment in the parent trial that required the use of an investigational device, drug or biologic.
结局指标
主要结局
Knee pain
时间窗: 14 weeks post intervention
Assessment of knee pain relief associated with knee osteoarthritis using VAS instrument scale
Knee pain and function
时间窗: 14 weeks post intervention
Assessment of knee pain relief and function improvements associated with knee osteoarthritis using WOMAC survey
次要结局
- Knee function(14 weeks post intervention)
研究者
研究点 (8)
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