Clinical trial NCT02761928: Investigation of Hypermobility, Biomarkers, and Pain Generators in Chronic Pain Patients
Official title: Investigation of Hypermobility, Biomarkers, and Pain Generators in Chronic Pain Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Low Back Pain, Mechanical
Spinal Stenosis
Nerve Root Disorder
Radiculopathy, Cervical
Benign Hypermobility Syndrome
Keywords: Facet Joint
Sacroiliac Joint
Myofascial Trigger Point Pain
Injectables
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2016-05-04
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with low back pain who are determined to be candidates for a pain procedure

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Beighton hypermobility score
timeFrame: Prior to injection (2 weeks prior to injection for each patient)
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Mark Burish, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grahame R. Joint hypermobility syndrome pain. Curr Pain Headache Rep. 2009 Dec;13(6):427-33. doi: 10.1007/s11916-009-0070-5.