Clinical Efficacy and Safety of Axiom Worldwide DRX9000 Axial Decompression
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- The primary outcome measure is lower back pain measured on an 11-point numeric rating scale (VRS) with 0 reflecting no pain at all and 10 the worst imaginable pain.
研究概览
简要总结
This study will document efficacy and safety of the Axiom Worldwide DRX9000™ for treatment of low back pain (LBP) in a prospective, randomized, crossover, multicenter trial utilizing a standardized clinical research multimodal protocol. During the first two weeks subjects are randomized to receive either conservative care or DRX treatment first and then cross over to receive either conservative care or DRX treatment the next 6 weeks. This study will test the hypothesis that standardized 6-week treatment regimen of spinal decompression using DRX9000™ will reduce chronic lower back pain more than conservative therapy (current baseline therapy).
详细描述
This study will document efficacy and safety of the Axiom Worldwide DRX9000™ for treatment of low back pain (LBP) in a prospective, randomized, crossover, multicenter trial utilizing a standardized clinical research multimodal protocol. During the first two weeks subjects are randomized to receive either conservative care or DRX treatment first and then cross over to receive either conservative care or DRX treatment the next 6 weeks. This study will test the hypothesis that standardized 6-week treatment regimen of spinal decompression using DRX9000™ will reduce chronic lower back pain more than conservative therapy (current baseline therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •In addition to a diagnosis of LBP, ALL of the following criteria must be met:
- •Male or female, >18 years of age
- •Able to provide written informed consent (ICF) to the IRB approved clinical multimodal protocol
- •Chronic (onset more than 12 weeks) low back pain with an intensity level of > 4 on a verbal rating scale for pain (VRS) of 0-10 (with 0 = no pain and 10 = worst possible pain)
- •Completed necessary diagnostic medical history evaluation forms as described in the protocol to confirm the patient's diagnosis and eligibility for the study
- •Willing and able to complete the 6 week 20 session DRX9000 outpatient treatments and a minimum of 6 months follow-up
排除标准
- •If ANY of the following exclusion criteria are present, the subject is NOT eligible:
- •Pregnancy
- •Evidence of neurologic motor deficits on clinical examination
- •Evidence of spinal cord compression, metastatic cancer, tumor, hematoma, infection or compression fracture
- •Severe spinal stenosis
- •Litigation for health-related claim (in process or pending), Worker's Compensation, or Personal Injury cases
- •Previous spine fusion surgery or instrumentation
- •Hemiplegia or paraplegia
- •Significant cardiovascular or metabolic disease, or abdominal aortic aneurysm
- •Unwillingness to postpone other types of therapy for LBP that are not listed as adjuncts in the research protocol
- •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
The primary outcome measure is lower back pain measured on an 11-point numeric rating scale (VRS) with 0 reflecting no pain at all and 10 the worst imaginable pain.
时间窗: 1 year
次要结局
- Recurrence rate, measured by the proportion of patients with VRS ≥ 4(1 year)
- Patient's satisfaction with procedures and treatment(1 year)
- Incidence of adverse events(1 year)
- Proportion of patients using adjuvant analgesic medication(1 year)
- Functional capacity, measured by the established Oswestry Disability Index(1 year)
研究者
Joseph Pergolizzi, MD
Principal Investigator
NEMA Research, Inc.