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

NCT02761928 | Terminated

• 1 other identifier: HSC-MS-15-0809
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Beighton hypermobility score

  9 point standardized scale

  Prior to injection (2 weeks prior to injection for each patient)

Study Arms (10)

Epidural

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

Other: Beighton score for hypermobility

Selective nerve root block

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

Other: Beighton score for hypermobility

Facet injection

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

Other: Beighton score for hypermobility

Medial branch block

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

Other: Beighton score for hypermobility

Medial branch RFA

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

Other: Beighton score for hypermobility

SIJ injection

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

Other: Beighton score for hypermobility

Lateral branch block

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

Other: Beighton score for hypermobility

Greater trochanter injection

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

Other: Beighton score for hypermobility

Piriformis injection

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

Other: Beighton score for hypermobility

Trigger point injection

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

Other: Beighton score for hypermobility

Interventions

Beighton score for hypermobility OTHER

The beighton score is a 9 point score of flexibility, used for patients with disorders of collagen.

Epidural; Facet injection; Greater trochanter injection; Lateral branch block; Medial branch RFA; Medial branch block; Piriformis injection; SIJ injection; Selective nerve root block; Trigger point injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

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)

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

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

  PMID: 19889283 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, saliva

MeSH Terms

Conditions

Low Back Pain; Spinal Stenosis; Radiculopathy; Ehlers-Danlos syndrome type 3; Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Muscular Diseases

Study Officials

• Mark Burish, MD PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 24, 2016
• First Posted: May 4, 2016
• Study Start: January 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: November 12, 2020

Record last verified: 2020-11

Locations

US (1)