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

Stopped early

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

In brief

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.

Key facts

Study ID

NCT02761928

Run by

The University of Texas Health Science Center, Houston

People needed

31

Starts

2016-01-01

Expected to finish

2017-08-01

Last updated by the study team

2020-11-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• University of Texas Health Science Center at Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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