Radiofrequency Denervation and Brain Structure, Function And Connectivity In Chronic Low Back Pain Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- resting state functional connectivity of default mode network
研究概览
简要总结
The goal of this observational study is to learn about changes in brain and its activity of following radiofrequency denervation treatment for chronic low back pain. The main question it aims to answer are:
- report the magnitude of the brain changes following radiofrequency treatment for low back pain.
- identify changes unique to radiofrequency treatment
Patients with nociceptive type low back pain of moderate to severe intensity will be identified to undergo radiofrequency treatment. They will have 3 MRI scans - Baseline, after the diagnostic injections and 3 months after radiofrequency treatment. They will also fill questions relating to their pain, disability and health related quality of life.
详细描述
Low back pain is one of the most common pain conditions and is the leading cause of years lived with disability. The management is challenging due to the heterogeneity of clinical presentation and includes self-management, pain killers, targeted injections as well as pain management programs. Brain MRI scans have identified networks of brain regions and changes in their activity in chronic low back pain (cLBP) patients. The scans have also been used to explore treatment-induced changes in brain and its activity. Radiofrequency denervation (RFD) of medial branch nerves is a NICE recommended treatment for a sub-group of cLBP sufferers. There are inter-individual variations in the response to RFD, which have been difficult to predict. The brain MRI scans can be used to better understand the effects of RFD on brain structure and function, and to predict those most likely to benefit from the interventions. So, we propose pilot study to investigate brain regions, their patterns and change after RFD treatment in this subgroup of cLBP sufferers. Eligible patients will have 3 brain MRI scans at various time intervals - Baseline, after nerve block and after RFD.
These brain scans will be analysed to provide the foundations for new studies such as improved selection of patients most likely to benefit from the treatment; improved understanding of mechanisms of the RFD treatment; and develop objective measurements that could be used in future trials of pain treatments.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Age 18 years or older
- •Chronic moderate to severe cLBP (defined by average pain intensity of ≥ 4 in the 11 point Numerical Pain rating scale and a minimum duration of 1 year)
- •Identified by clinical team as suitable for RFD pathway
- •Predominantly nociceptive pain (as defined by PainDetect score ≤12)
- •Stable on current analgesic regime
- •Able to communicate in English
- •Has the capacity to and agrees to give informed consent for participation in the study
- •Positive response to a single diagnostic MBB with 1 ml or less of local anaesthetic (bupivacaine 0.5%) at each level. (a positive response is defined as ≥80% pain relief at 3 hours, based on patient reported assessment)
排除标准
- •Any patient whose physical condition will preclude them from lying still for the duration of the brain scan.
- •Contraindication to magnetic resonance scanning such as an implantable cardiac device.
- •Women who are, or may be, pregnant. (Pregnant patients do not undergo pain procedures under radiological guidance as per routine clinical care)
- •Significant anxiety and depression (as defined by HADS score ≥ 9)
- •Clinical suspicion that alternative diagnosis is the reason for LBP
- •Presence of chronic primary pain conditions (Fibromyalgia, chronic widespread pain, Complex Regional Pain Syndrome, Chronic Primary Headache, Orofacial pain, Chronic primary visceral pian and Chronic Primary musculoskeletal pain as defined by ICD-11 classification)
- •Presence of thoracic or neck pain
- •History of previous RF denervation
- •Regular use of two or more dependence forming drugs (opioids, gabapentinoids, Benzodiazepines, tricyclics antidepressants and z-drugs)
结局指标
主要结局
resting state functional connectivity of default mode network
时间窗: 3 months after treatment
Any difference between baseline and after successful treatment will be reported as primary outcome measure.
次要结局
未报告次要终点