Investigation of Hypermobility, Biomarkers, and Pain Generators in Chronic Pain Patients (Hypermoble)

The University of Texas System (UT)

Status: Terminated

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

Treatments: Other: Beighton score for hypermobility

Study type: Observational

Funder types: Other

Identifiers

NCT02761928

HSC-MS-15-0809

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

31 participants in 10 patient groups

Epidural

Description:

Positive response (\>50% pain relief) to any epidural (e.g. interlaminar/paramedian, transforaminal, caudal)

Treatment:

Other: Beighton score for hypermobility

Selective nerve root block

Description:

Positive response (\>50% pain relief) to selective nerve root block

Treatment:

Other: Beighton score for hypermobility

Facet injection

Description:

Positive response (\>50% pain relief) to intra-articular facet injection

Treatment:

Other: Beighton score for hypermobility

Medial branch block

Description:

Positive response (\>50% pain relief) to median branch nerve block

Treatment:

Other: Beighton score for hypermobility

Medial branch RFA

Description:

Positive response (\>50% pain relief) to median branch nerve radiofrequency ablation

Treatment:

Other: Beighton score for hypermobility

SIJ injection

Description:

Positive response (\>50% pain relief) to sacroiliac joint injection

Treatment:

Other: Beighton score for hypermobility

Lateral branch block

Description:

Positive response (\>50% pain relief) to lateral branch nerve block for SIJ

Treatment:

Other: Beighton score for hypermobility

Greater trochanter injection

Description:

Positive response (\>50% pain relief) to greater trochanteric bursa injection

Treatment:

Other: Beighton score for hypermobility

Piriformis injection

Description:

Positive response (\>50% pain relief) to piriformis injection

Treatment:

Other: Beighton score for hypermobility

Trigger point injection

Description:

Positive response (\>50% pain relief) to trigger point injection

Treatment:

Other: Beighton score for hypermobility