A Prospective, Single Center, Double Blind, Randomized, Sham Controlled, Crossover Study to Evaluate the Clinical Efficacy of Radiofrequency Nerve Ablation Using Simplicity III Versus Sham for the Treatment of Chronic Low Back Pain Associated With Sacroiliac Joint Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Reduction in pain
研究概览
简要总结
Trial will enroll qualified subjects at a 2:1 ration to receive radiofrequency ablation or sham. At six weeks follow up they will be unblinded; sham subjects will then be given option to receive treatment.
Subjects will be followed after procedure for data collection for economic outcomes and efficacy of treatment.
详细描述
Patients presenting with low back pain associated with SIJD for longer than 6 months, and who have not had positive responsive to the conservative treatments:
- Pharmacologic Management
- Therapies; physical, acupuncture, massage etc...
- Other alternative treatments
Enrollment, Treatment/Sham Procedure, Follow-up at 3 weeks, 6 weeks with unblinding, 4, 6, 9 months. Un-blinding occurring at 6 weeks with crossover option to receive treatment. Total visits 7 with enrollment approximately over a period of 9 months. Trial extension optional for phone contact at year 1, 2. Sham subjects receiving treatment will be followed at months 6 weeks, 4, and 6 months with phone calls at year 1, 2.
Patients who complete at least 50% of their patient diaries, and miss no more 2 consecutive office visits. Data will be used if patients have remained enrolled thru 4 month visit.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
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
- •18 years old, or older
- •Unilateral or Bilateral LBP or Buttocks Pain for greater than six months with a 3 day average VAS greater or equal to 4 on a 1-10 scale
- •Tenderness over the SI joint
- •75% or greater relief of pain (with return to baseline) during the local anesthetic phase of two separate, one fluoroscopically guided intra-articular SI joint injection and one lateral branch block (see Appendix A)
- •Stable medications for pain for the last seven days
- •Have used at least 3 alternative treatments for pain without success (se
- •BMI less than 35.0
排除标准
- •Focal Neurologic Signs
- •Any component of pain related to Lumbar Z-joints at L4-5 and/or L5-S1 as determined by one set of medial branch blocks
- •Previous radiofrequency procedure within the last 6 months
- •Moderate or greater spinal stenosis
- •Greater than Grade 2 listhesis
- •Foraminal Stenosis; marked to severe
- •Previous Lumbar Spine Surgery
- •Unstable Medical or Psychological Conditions as determined by the investigator
- •Concomitant cervical or thoracic pain greater than 2/10 on VAS
- •Workers compensation, disability or litigation
- •Pregnancy, breast feeding or planning on becoming pregnant during the trial
- •Subject unwillingness to complete study related activities
- •Current Smoker; unless quit greater than 6 months -
结局指标
主要结局
Reduction in pain
时间窗: 6 months
• To evaluate the clinical efficacy of RF lesioning of sensory innervation of the sacroiliac region as a long term treatment for pain associated with SI joint dysfunction as measured by the reduction in VAS scale and the use of pain alleviating therapies
次要结局
- Economic outcomes(1 year)