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

study id #: NCT02761928

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

status: active, not recruiting

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.

intervention: Other: Beighton score for hypermobility
The beighton score is a 9 point score of flexibility, used for patients with disorders of collagen.

start date: January 2016

estimated completion: December 2025

last updated: October 10, 2018

phase of development: N/A

size / enrollment: 2000

study design: Observational Model: Cohort
Time Perspective: Prospective

study description:
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.

primary outcomes:

• Beighton hypermobility score [ Time Frame: Prior to injection (2 weeks prior to injection for each patient) ]
  9 point standardized scale

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)

sponsor: The University of Texas Health Science Center, Houston

investigators: Mark Burish, MD PhD

locations: United States