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

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ClinicalTrials.gov Identifier: NCT02761928
Recruitment Status : Active, not recruiting
First Posted : May 4, 2016
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
Mark J Burish, The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment
Low Back Pain, Mechanical Spinal Stenosis Nerve Root Disorder Radiculopathy, Cervical Benign Hypermobility Syndrome 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.

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigation of Hypermobility, Biomarkers, and Pain Generators in Chronic Pain Patients
Study Start Date : January 2016
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

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.




Primary Outcome Measures :
  1. Beighton hypermobility score [ Time Frame: Prior to injection (2 weeks prior to injection for each patient) ]
    9 point standardized scale


Biospecimen Retention:   Samples With DNA
Blood, urine, saliva


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with low back pain who are determined to be candidates for a pain procedure
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02761928


Locations
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United States, Texas
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Mark Burish, MD PhD The University of Texas Health Science Center, Houston

Publications:
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Responsible Party: Mark J Burish, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02761928     History of Changes
Other Study ID Numbers: HSC-MS-15-0809
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018

Keywords provided by Mark J Burish, The University of Texas Health Science Center, Houston:
Facet Joint
Sacroiliac Joint
Myofascial Trigger Point Pain
Injectables

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Chronic Pain
Spinal Stenosis
Radiculopathy
Ehlers-Danlos Syndrome
Pain
Neurologic Manifestations
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Collagen Diseases
Connective Tissue Diseases
Skin Diseases