Investigation of Hypermobility, Biomarkers, and Pain Generators in Chronic Pain Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Beighton hypermobility score
研究概览
简要总结
Observational study of axial spine pain and hyperflexibility. Patients will receive physical exam maneuvers (traditional straight leg raise, FABER, facet loading as well as Beighton's hypermobility score) and blood / urine / saliva collection. They will also be separated into pain groups based on their response to injections. A correlation between exam findings and procedure group will be measured.
详细描述
This is an observational study of patients with neck and back pain followed by a pain management clinic. Patients with particular pain generators in the neck and back will be defined by a positive response to one of several targeted interventional pain procedures. Each patient may undergo a physical exam to determine whether they have hypermobile joints. The study will thus evaluate the rate of hypermobility for each pain generator. In addition blood, urine, or saliva samples may be taken for biomarkers for pain or rheumatologic factors.
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
- •Clinical diagnosis of axial back pain (neck, mid-back, lower back) or pain radiating to the extremity, with suspected diagnosis of a specific pain generator amenable to a pain procedure, including disorders of the nerves, joints, and muscles as listed immediately below.
- •Clinical decision to schedule patient for a pain procedure, including procedures targeting the following disorders:
- •Facet arthropathy: intra-articular facet joint injection, medial branch block, medial branch radiofrequency ablation
- •Sacroiliac joint dysfunction: sacroiliac joint injection, lateral branch block, lateral branch radiofrequency ablation
- •Myofascial pain syndrome: trigger point injection
- •Radiculopathy, spinal stenosis, or herniated nucleus pulposus: epidural steroid injection, selective nerve root block
- •Piriformis syndrome: piriformis injection
- •Greater trochanteric bursitis: greater trochanteric bursa injection
- •Able to provide HIPAA authorization to share prior medical records/imaging.
排除标准
- •Previous diagnosis of cancer.
- •Currently pregnant.
- •Previously enrolled for the same procedure or the same pain generator site. (For example, this would exclude a patient who had an intra-articular facet joint injection at the right L5/S1 if: 1) he had the same injection 3 months ago and was enrolled at that time, or 2) the patient was already enrolled for a medial branch block at the right L5 and sacral ala, as this targets the same facet joint.)
- •Inability or unwillingness of subject or legal guardian/representative to give informed consent (e.g., ward of the state)
结局指标
主要结局
Beighton hypermobility score
时间窗: Prior to injection (2 weeks prior to injection for each patient)
9 point standardized scale
次要结局
未报告次要终点
研究者
Mark J Burish
Assistant Professor
The University of Texas Health Science Center, Houston