Pilot Study to Evaluate The Effectiveness And Safety Of Axiom Worldwide Drx9000™ Spinal Decompression System For Treatment of Low Back Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 6
- 主要终点
- Post-treatment Numerical Pain Intensity Rating Scale (VRS), Which is a Scale From 0-10 (0=no Pain, 10= Worst Pain)
研究概览
简要总结
This pilot study will evaluate the effectiveness and safety of the Axiom Worldwide DRX9000 for active treatment of chronic low back pain.
详细描述
Currently, there are no prospective safety and/or outcomes studies utilizing the DRX9000™ in the peer-reviewed medical literature. There are published trials utilizing similar machines which provided evidence in support of the FDA granted indications for use spinal decompression and of the DRX9000™. Axiom Worldwide has determined it will be of benefit to the continuing medical care of patients and a furthering of the scientific knowledge of the treatment of LBP to complete such a prospective evaluation using a standardized treatment protocol. This study will therefore attempt to establish and validate the safety and efficacy of this computerized spinal decompression system in the treatment of LBP and sciatica.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, greater than 18 years of age
- •Able to understand possible risks and benefits and provide written informed consent (ICF) to the IRB approved clinical multimodal protocol
- •LBP with an intensity level of greater than 4 on an eleven point numerical pain rating scale (VRS) of 0-10 (with 0 - no pain and 10 - worst possible pain)
- •Completed the necessary diagnostic and medical history evaluations as described in the protocol to confirm the patient's diagnosis and eligibility for the study and DRX9000 treatment protocol.
- •Willing and able to complete a six week 20 session of DRX9000 outpatient treatments and a minimum of 6 months follow-up
排除标准
- •Pregnancy
- •Evidence of neurological motor deficits on clinical examination
- •Evidence of spinal cord compression, metastatic cancer, tumor, hematoma, infection or compression fracture
- •Evidence of severe central stenosis with neurological deficits or nerve root entrapment
- •Litigation for health-related claim (in process or pending), Worker's Compensation, or Personal Injury
- •Previous spine fusion surgery, insertion of hardware or artificial disc
- •Hemiplegia or paraplegia
- •History of severe cardiovascular or metabolic disease, or abdominal aortic aneurysm
- •Unwillingness to postpone other types of therapy for LBP during the 6 week treatment sessions
- •Known alcohol abuse or drug abuse
- •Height less than 4 feet 10 inches (147 cm) or greater than 6 feet 8 inches (203 cm)
- •Body weight greater than 300 pounds (136 kg)
结局指标
主要结局
Post-treatment Numerical Pain Intensity Rating Scale (VRS), Which is a Scale From 0-10 (0=no Pain, 10= Worst Pain)
时间窗: Six weeks
The numerical results of the post-treatment verbal numerical pain intensity rating scale (VRS) following completion of a standard six week series of 20 DRX9000 treatments.
次要结局
- Recurrence for Significant (VRS Greater Than or Equal to 4) LBP Following Completion of 6 Weeks of DRX9000 Treatment.(Six weeks)
- Change in Functional Capacity From Baseline to Six Weeks (The Revised Oswestry Pain Questionaire)(Six weeks)
- Patient's Satisfaction With Treatment Procedures Following 6 Weeks of DRX9000 Treatment.(Six weeks)
- Number of Adverse Events Following 6 Weeks of DRX9000 Treatment.(Six weeks)
- Number of Patients Who Withdraw From Study.(6 weeks)