NCT01507818终止不适用
Impact of Non-thermal Pulsed Radio Frequency (PRF)on Narcotic Use, Pain, and Health-related Quality of Life Following Shoulder Arthroscopic Rotator Cuff Repair: A Double-Blind, Randomized Sham-Controlled Trial
Amp Orthopedics, Inc.6 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2011年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 37
- 试验地点
- 6
- 主要终点
- Average daily narcotic consumption (oxycodone mg)
研究概览
简要总结
To determine the effectiveness of non-thermal PRF delivered with the Ivivi Torino II on narcotic use, pain, and health-related quality of life following shoulder arthroscopic rotator cuff surgery comparing: Active treatment versus placebo (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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MRI diagnosis of rotator cuff tear
- •Persistent symptoms despite a minimum of 6 months of failed non-operative management
- •Scheduled for primary or revision arthroscopic rotator cuff repair (with or without any of the following: debridement, subacromial decompression, distal clavicle resection, treatment of biceps tendon and /or glenoid labrum pathology, release of capsule).
- •Age 40 to 80 years
- •Able to read and complete English-language surveys
- •Ability of the participant to comprehend the full nature and purpose of the study including possible risks and side effects
- •Willingness and ability to comply with study product and methods
排除标准
- •Diagnosis of adhesive capsulitis requiring global capsular release, instability, fracture, or arthritis
- •Any implanted metallic leads, wires, or systems (e.g. pacemaker, implantable cardioverter-defibrillator)
- •Known narcotic allergy, hepatitis, nephritis, or gastrointestinal ulcer
- •Chronic narcotic pain medication dependency
- •Vulnerable populations including prisoners, pregnant women, nursing home residents, the Investigator's students and employees, employees of sponsor, those unable to consent for themselves, uninsured subjects or others who could be subject coercion
- •Worker's compensation claimant
- •Medical condition, in the judgement of the patient's physician, which may interfere with the shoulder surgery or the effectiveness or safety of the study treatment
- •Use of oral prednisone in the past 30 days
- •Use of any investigational drug or participation in another research study within the past 30 days
- •Self-reported diagnosis of autoimmune or inflammatory arthritis (e.g. Rheumatoid Arthritis, Lupus, ets.)
结局指标
主要结局
Average daily narcotic consumption (oxycodone mg)
时间窗: week-1 post surgery
Average, daily, patient-reported narcotic consumption (converted to oxycodone equivalents in mg) during Week 1.
次要结局
- Adverse Events(Weeks 1-6 post surgery)
- Patient-reported general health-related quality of life score (EQ-5D)(On the last day of Weeks 1-6)
- Average daily narcotic consumption (oxycodone mg)(Weeks 2-6 post surgery)
- Visual Analogue Scale (VAS) pain(Weeks 2-6 post surgery)
研究者
研究点 (6)
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