NCT00450905终止3 期
Randomized Evaluation of a Low-Frequency Investigational Device Employing Neuromodulation Therapy in Patients With Fibromyalgia
Fralex Therapeutics21 个研究点 分布在 2 个国家目标入组 200 人开始时间: 2007年3月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 200
- 试验地点
- 21
- 主要终点
- Clinically significant pain reduction, evidenced by a statistically significant difference between active and placebo groups in percentage of subjects who achieve a pain reduction of at least 30% at week 12 as compared to the Baseline.
研究概览
简要总结
This study is being performed to determine the safety and efficacy of Fralex Neuromodulation Therapy (F-NMT), delivered by the Fralex PRIMA device, in reducing chronic musculoskeletal pain associated with Fibromyalgia.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic musculoskeletal pain of at least six months duration secondary to FMS using American College of Rheumatology (ACR) criteria and with the minimum of 11 of 18 defined tender points, measured by dolorimeter at a threshold of up to 4 kg of pressure
- •Males and females, 18 years and older
- •Able to complete assessment index forms unaided by caregiver/interpreter
- •Pain score of 4 or greater on the Numerical Rating Scale (NRS), averaged from the Baseline Period scores recorded on the 7 days immediately prior to randomization
- •Demonstration of stabilized pain scores as measured on the NRS during the Baseline Period (Days -7 to -1)
- •Able to tolerate prohibition of all medications for pain, depression and sleep disorders except for acetaminophen (up to 4 g/day) and cardiac aspirin (up to 325 mg/day) demonstrated for the Stabilization and Baseline Periods prior to randomization
- •Able and willing to provide a written informed consent
排除标准
- •Unwilling or unable to sign an informed consent, or to comply with the protocol
- •Evidence of inflammatory rheumatic disease, secondary fibromyalgia, or other severe painful disorders that might confound assessment of FMS pain
- •Currently under treatment (pharmacological or cognitive therapy) for a Major Depressive Episode (MDE) or has demonstrated suicidal ideation in the past
- •History or current treatment of migraine, tension or cluster headache requiring regular medication
- •History or current treatment of seizure disorder
- •History or current treatment of cancer with the exception of basal cell carcinoma and cervical dysplasia
- •Cognitive dysfunction or personality disorder which would preclude self-directed treatment, self assessment and / or diary completion
- •Clinically significant or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise participation
- •Hearing aids, metal implants (excludes dental work) above mid torso or in the cranium (e.g. plates, implants or clips). (Metal implants in parts of the body below mid-torso, such as knee or hips replacements, clips, screws or plates to stabilize fractures are acceptable)
- •Pacemakers, defibrillators, implanted neurostimulators, implanted drug pumps or other electrical implanted devices
- •Insufficient knowledge of English to complete the self-assessment forms
- •History of or current drug or alcohol abuse
- •History of abuse of a previous physician relationship or the medical system
- •Receiving disability insurance, applying for disability insurance, or engaged in litigation related to FMS
- •Use of an investigational drug or device in a controlled study within 30 days
- •Pregnancy (U.S. sites only)
- •Breastfeeding or intending to breastfeed (U.S. sites only)
结局指标
主要结局
Clinically significant pain reduction, evidenced by a statistically significant difference between active and placebo groups in percentage of subjects who achieve a pain reduction of at least 30% at week 12 as compared to the Baseline.
次要结局
- Additional outcome measures will include mood alteration, sleep quality, improvement of physical functioning and relief medication usage by subjects in both groups.
研究者
研究点 (21)
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