NCT04128618已完成不适用
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, Inc2 个研究点 分布在 1 个国家目标入组 159 人开始时间: 2019年10月8日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 159
- 试验地点
- 2
- 主要终点
- Knee pain using VAS scale (Visual Analog Scale)
研究概览
简要总结
Evaluation of knee pain and functional mobility of knee osteoarthritis patients with a home-based neuromuscular electrical stimulation (NMES) therapy
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
Subjects, coordinators, and Investigators are blinded.
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must provide written, informed consent before any study procedures occur. The subject should be provided with a copy of the signed Informed Consent upon signature.
- •Subjects with symptomatic Kellgren-Lawrence (KL) Grade 2, 3, or 4 OA by radiograph (AP tunnel view) within 30 days prior to day 0 visit, where the K-L grades are defined as:
- •Grade 0: no radiographic features of OA are present
- •Grade 1: doubtful joint space narrowing (JSN) and possible osteophytic lipping
- •Grade 2: definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph
- •Grade 3: multiple osteophytes, definite JSN, sclerosis, possible bony deformity
- •Grade 4: large osteophytes, marked JSN, severe sclerosis and definite bony deformity
- •Subject must have a normal tibiofemoral angle (0-8°) and a joint space width of ≥ 3mm confirmed by radiograph.
- •Subjects who are between the ages of 21 - 85 years.
- •Subjects must have a visual analog pain (VAS) score of at least 4 cm on a 10 cm scale for a nominated activity in the target knee at the time of screening.
- •For bilateral knee osteoarthritis subjects, the visual analog pain VAS score for a nominated activity of the contralateral knee must be less than 4 cm on the VAS scale.
- •Subject has access to a smartphone or tablet (Android or iOS).
- •Subject must be ambulatory.
- •Subject must be willing to discontinue 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 be willing to take acetaminophen (up to 3000 mg/day) or an equivalent as pain medication for the duration of the study.
- •Subject must be willing to stop taking any pain medications 24 hours prior any scheduled study visit.
- •Subject must be willing to stop receiving knee physical therapy of the target knee for the duration of the study.
- •Subject must be willing to stop wearing any knee unloader brace of the target knee for the duration of the study.
- •Subjects must be proficient in English.
- •Subjects must be willing and able to comply with all study procedures for the duration of the clinical study
排除标准
- •Subjects who have a body mass index ≥ 40 at the time of consent (at the discretion of the PI).
- •Subjects with a diagnosis of inflammatory arthritis (knee rheumatoid arthritis, active gout, knee joint infection, Lyme disease, SLE, etc.).
- •Subjects with a diagnosis of severe neuropathy condition for the past 6 months and under medication for treatment of the condition.
- •Subjects with a diagnosis of fibromyalgia for the past year.
- •Subjects who have had an injury or an acute traumatic injury to the target knee within 6 months of screening.
- •Subject must NOT have had arthroscopy of the target knee within 8 weeks of randomization.
- •Subjects who have had treatment of the target knee with intra-articular injections of steroids within 8 weeks of screening.
- •Subjects who have had intra-articular injections of hyaluronic acid within 12 weeks of screening.
- •Subjects who have had a scheduled surgery on the target knee within the study period.
- •(Note- Subjects who are scheduled to go under total knee replacement surgery within the next 3 months at screening will not be enrolled. Subjects that are contemplating the surgery can be included.)
- •Subjects who have used electrotherapy or acupuncture for OA of the target knee within 4 weeks of screening.
- •Subjects who have used Neuromuscular Electrical Stimulation (NMES) in the past year.
- •Subjects with significant and clinically evident mal-alignment of the target knee (> 5 degrees varus or valgus in the target knee).
- •Subjects with surgical metallic hardware in the target knee.
- •Subjects who have had implanted electrical devices (cardiac pacemakers, deep brain stimulators, implantable cardiac defibrillators).
- •Subjects who have contraindications to X-rays.
- •Subjects with a current malignancy or who have received treatment for malignancy with the last 5 years, with the exception of resected basal cell carcinoma and squamous cell carcinoma of the skin.
- •Subjects who have an active substance abuse problem (drugs or alcohol) or a history of chronic substance abuse (> 5 years).
- •Subjects with skin breakdown or infection in the area where the study device will be placed (quadriceps of the target knee).
- •Subjects with any chronic conditions (e.g., diabetes, hypertension, congestive heart failure, etc.) that have not been well-controlled for at least 3 months prior to screening.
- •Subjects who have any ongoing litigation for worker's compensation.
- •Subjects with any condition, in the opinion of the Investigator that might interfere with the evaluation of the study objectives.
- •Subjects who are pregnant.
- •Subject must not have participated in a clinical study within the past 12 weeks from the last day of treatment that required the use of an investigational device, drug or biologic
研究组 & 干预措施
Modified NMES sham
Sham Comparator
干预措施: CyMedica e-vive NMES (Device)
Active NMES
Experimental
干预措施: CyMedica e-vive NMES (Device)
结局指标
主要结局
Knee pain using VAS scale (Visual Analog Scale)
时间窗: 12 weeks post intervention
Pain associated with knee osteoarthritis- Unit none (score)
次要结局
- Timed Up & Go (TUG)(12 weeks post intervention)
- Quadriceps muscle strength(12 weeks post intervention)
- Repeated Chair Rise(12 weeks post intervention)
- 3 min walk test(12 weeks post intervention)
- KOOS JR. Survey(12 weeks post intervention)
- WOMAC Survey(12 weeks post intervention)
研究者
研究点 (2)
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