Investigation of Hypermobility, Biomarkers, and Pain Generators in Chronic Pain Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Investigation of Hypermobility, Biomarkers, and Pain Generators in Chronic Pain Patients

Conditions
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Low Back Pain, Mechanical, Spinal Stenosis, Nerve Root Disorder, Radiculopathy, Cervical, Benign Hypermobility Syndrome

Intervention / Treatment
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* Other: Beighton score for hypermobility


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Epidural<br>Positive response (>50% pain relief) to any epidural (e.g. interlaminar/paramedian, transforaminal, caudal) | Other: Beighton score for hypermobility<br>* The beighton score is a 9 point score of flexibility, used for patients with disorders of collagen.<br>|
| Selective nerve root block<br>Positive response (>50% pain relief) to selective nerve root block | Other: Beighton score for hypermobility<br>* The beighton score is a 9 point score of flexibility, used for patients with disorders of collagen.<br>|
| Facet injection<br>Positive response (>50% pain relief) to intra-articular facet injection | Other: Beighton score for hypermobility<br>* The beighton score is a 9 point score of flexibility, used for patients with disorders of collagen.<br>|
| Medial branch block<br>Positive response (>50% pain relief) to median branch nerve block | Other: Beighton score for hypermobility<br>* The beighton score is a 9 point score of flexibility, used for patients with disorders of collagen.<br>|
| Medial branch RFA<br>Positive response (>50% pain relief) to median branch nerve radiofrequency ablation | Other: Beighton score for hypermobility<br>* The beighton score is a 9 point score of flexibility, used for patients with disorders of collagen.<br>|
| SIJ injection<br>Positive response (>50% pain relief) to sacroiliac joint injection | Other: Beighton score for hypermobility<br>* The beighton score is a 9 point score of flexibility, used for patients with disorders of collagen.<br>|
| Lateral branch block<br>Positive response (>50% pain relief) to lateral branch nerve block for SIJ | Other: Beighton score for hypermobility<br>* The beighton score is a 9 point score of flexibility, used for patients with disorders of collagen.<br>|
| Greater trochanter injection<br>Positive response (>50% pain relief) to greater trochanteric bursa injection | Other: Beighton score for hypermobility<br>* The beighton score is a 9 point score of flexibility, used for patients with disorders of collagen.<br>|
| Piriformis injection<br>Positive response (>50% pain relief) to piriformis injection | Other: Beighton score for hypermobility<br>* The beighton score is a 9 point score of flexibility, used for patients with disorders of collagen.<br>|
| Trigger point injection<br>Positive response (>50% pain relief) to trigger point injection | Other: Beighton score for hypermobility<br>* The beighton score is a 9 point score of flexibility, used for patients with disorders of collagen.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beighton hypermobility score | 9 point standardized scale | Prior to injection (2 weeks prior to injection for each patient) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Facet Joint, Sacroiliac Joint, Myofascial Trigger Point Pain, Injectables