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

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.

Study Overview

• Status: Terminated
• Conditions: Low Back Pain, Mechanical; Spinal Stenosis; Radiculopathy, Cervical; Benign Hypermobility Syndrome; Nerve Root Disorder
• Intervention / Treatment: Other: Beighton score for hypermobility

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.

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with low back pain who are determined to be candidates for a pain procedure

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

10

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Epidural; Positive response (>50% pain relief) to any epidural (e.g. interlaminar/paramedian, transforaminal, caudal)	Other: Beighton score for hypermobility; The beighton score is a 9 point score of flexibility, used for patients with disorders of collagen.
Selective nerve root block; Positive response (>50% pain relief) to selective nerve root block	Other: Beighton score for hypermobility; The beighton score is a 9 point score of flexibility, used for patients with disorders of collagen.
Facet injection; Positive response (>50% pain relief) to intra-articular facet injection	Other: Beighton score for hypermobility; The beighton score is a 9 point score of flexibility, used for patients with disorders of collagen.
Medial branch block; Positive response (>50% pain relief) to median branch nerve block	Other: Beighton score for hypermobility; The beighton score is a 9 point score of flexibility, used for patients with disorders of collagen.
Medial branch RFA; Positive response (>50% pain relief) to median branch nerve radiofrequency ablation	Other: Beighton score for hypermobility; The beighton score is a 9 point score of flexibility, used for patients with disorders of collagen.
SIJ injection; Positive response (>50% pain relief) to sacroiliac joint injection	Other: Beighton score for hypermobility; The beighton score is a 9 point score of flexibility, used for patients with disorders of collagen.
Lateral branch block; Positive response (>50% pain relief) to lateral branch nerve block for SIJ	Other: Beighton score for hypermobility; The beighton score is a 9 point score of flexibility, used for patients with disorders of collagen.
Greater trochanter injection; Positive response (>50% pain relief) to greater trochanteric bursa injection	Other: Beighton score for hypermobility; The beighton score is a 9 point score of flexibility, used for patients with disorders of collagen.
Piriformis injection; Positive response (>50% pain relief) to piriformis injection	Other: Beighton score for hypermobility; The beighton score is a 9 point score of flexibility, used for patients with disorders of collagen.
Trigger point injection; Positive response (>50% pain relief) to trigger point injection	Other: Beighton score for hypermobility; The beighton score is a 9 point score of flexibility, used for patients with disorders of collagen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beighton hypermobility score	9 point standardized scale	Prior to injection (2 weeks prior to injection for each patient)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Mark Burish, MD PhD, The University of Texas Health Science Center, Houston

Publications and helpful links

General Publications

• Grahame R. Joint hypermobility syndrome pain. Curr Pain Headache Rep. 2009 Dec;13(6):427-33. doi: 10.1007/s11916-009-0070-5.

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: April 24, 2016
• First Submitted That Met QC Criteria: May 3, 2016
• First Posted (Estimate): May 4, 2016

Study Record Updates

• Last Update Posted (Actual): November 12, 2020
• Last Update Submitted That Met QC Criteria: November 9, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Sacroiliac Joint; Myofascial Trigger Point Pain; Facet Joint; Injectables
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Spinal Diseases; Bone Diseases; Back Pain; Low Back Pain; Chronic Pain; Radiculopathy; Spinal Stenosis
• Other Study ID Numbers: HSC-MS-15-0809