ClinicalTrials.Veeva

Menu

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

The University of Texas System (UT) logo

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems