ACTRN12614000902695招募中未知
A Prospective, Open-Label, Pilot Study to Assess the Effect of Spinal Cord Stimulation on Quality of Sleep and Activity Levels in patients with Chronic Low Back pain with or without Leg Pain
Dr. Bruce Mitchell0 个研究点目标入组 10 人开始时间: 2014年8月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. 18 years of age or older
- •2. Have undergone a positive Spinal Cord Stimulator (SCS) trial and scheduled for an SCS implant with the Medtronic RestoreSENSOR implantable pulse generator (IPG)
- •3. Subject is ambulatory
- •4. Diagnosed with low back pain or low back pain plus leg pain for at least 6 months
- •5. Undergoing treatment for low back pain or low back pain plus leg pain
- •6. Does not have or has not had a previous SCS implant
- •7. Willing and able to complete protocol requirements including:
- •a. Willing to wear a RestoreSENSOR device for 1 week during the baseline monitoring period
- •b. Willing and able to complete health questionnaires and pain scales as specified in the protocol
- •c. Willing and able to undergo a formal sleep examination
- •d. Willing and able to sign the study-specific Informed Consent form
- •8. Male or non-pregnant female
- •9. Patient is privately insured
排除标准
- •1. Have plans to enrol in another clinical study during their participation in this study, or are currently enrolled in a clinical study that could interfere in participation in the trial or affect the scientific soundness of this study
- •2. Cancer or any other malignant disease
- •3. Present or past diagnosis of schizophrenia or of delusional, psychotic, or dissociative disorder
- •4. A pain-related surgery in the previous 12 weeks of enrolment, the intent to undergo surgery during the period of the study
- •5. Non-English speaking or an inability to complete questionnaires accurately.
- •6. Previously diagnosed with sleep apnoea or other sleep disorder that would affect the objective measure of sleep quality following treatment.
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