Enhancing Cortical-hippocampal Functional Connectivity as a Novel Means for Relieving Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Changes in Pain Scales
研究概览
简要总结
In this study the investigators aim to examine the effects of Transcranial Magnetic Stimulation (TMS) on hippocampal network connectivity and pain levels in individuals with chronic low back pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, 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
- •≥ 6 months of back pain on a daily basis;
- •male or female with no racial or ethnic restrictions;
- •18 to 75 years old;
- •average back pain intensity > 4/10 at study entry;
- •must be able to read, understand, and sign consent form;
- •generally healthy.
排除标准
- •back pain with fever, chills, rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures,
- •history of tumor in the back;
- •back surgery within the past 6 months;
- •Chronic neurologic conditions, e.g., Parkinson's
- •involvement in litigation regarding back pain;
- •other severe medical diseases;
- •pregnancy;
- •positive urinary screen for any recreational drugs,
- •opioids use;
- •use of anticoagulants (low dose ASA allowed);
- •history of gastric ulcer; renal insufficiency or congestive heart failure,
- •contraindication to MRI,
- •contraindication to TMS; including history of seizure/epilepsy*
- •Any medical condition that in the investigator's judgment may prevent the individual from completing the study or put the individual at undue risk;
- •In the judgment of the investigator, unable or unwilling to follow protocol and instructions;
- •Diagnosis of major depression;
- •Intra-axial implants (e.g. spinal cord stimulators or pumps)
结局指标
主要结局
Changes in Pain Scales
时间窗: Pain is assessed at baseline, end of first intervention and end of the second intervention.
The endpoint will be the severity of pain measured by changes in the Numeric Rating Scale (NRS) scores before and after each stimulation round. The NRS is a pain screening tool that assesses pain severity during assessment using a 0-10 scale, where zero means "no pain" and ten means "the worst pain imaginable." Higher values indicate a worse outcome.
次要结局
- Changes in Hippocampal Connectivity(approximately 6 weeks - Baseline and after the end of hippocampal stimulation)
研究者
Apkar Apkarian
Director Center for Translational Pain Research, Director Center of Excellence for Chronic Pain and Drug Abuse Research, Professor of Physiology, Anesthesia, PM&R Northwestern University, Feinberg School of Medicine
Northwestern University