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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

Tracking Information
First Submitted Date April 24, 2016
First Posted Date May 4, 2016
Last Update Posted Date October 10, 2018
Study Start Date January 2016
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 3, 2016)
Beighton hypermobility score [ Time Frame: Prior to injection (2 weeks prior to injection for each patient) ]
9 point standardized scale
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02761928 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Investigation of Hypermobility, Biomarkers, and Pain Generators in Chronic Pain Patients
Official Title Investigation of Hypermobility, Biomarkers, and Pain Generators in Chronic Pain Patients
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood, urine, saliva
Sampling Method Non-Probability Sample
Study Population Patients with low back pain who are determined to be candidates for a pain procedure
Condition
  • Low Back Pain, Mechanical
  • Spinal Stenosis
  • Nerve Root Disorder
  • Radiculopathy, Cervical
  • Benign Hypermobility Syndrome
Intervention Other: Beighton score for hypermobility
The beighton score is a 9 point score of flexibility, used for patients with disorders of collagen.
Study Groups/Cohorts
  • Epidural
    Positive response (>50% pain relief) to any epidural (e.g. interlaminar/paramedian, transforaminal, caudal)
    Intervention: Other: Beighton score for hypermobility
  • Selective nerve root block
    Positive response (>50% pain relief) to selective nerve root block
    Intervention: Other: Beighton score for hypermobility
  • Facet injection
    Positive response (>50% pain relief) to intra-articular facet injection
    Intervention: Other: Beighton score for hypermobility
  • Medial branch block
    Positive response (>50% pain relief) to median branch nerve block
    Intervention: Other: Beighton score for hypermobility
  • Medial branch RFA
    Positive response (>50% pain relief) to median branch nerve radiofrequency ablation
    Intervention: Other: Beighton score for hypermobility
  • SIJ injection
    Positive response (>50% pain relief) to sacroiliac joint injection
    Intervention: Other: Beighton score for hypermobility
  • Lateral branch block
    Positive response (>50% pain relief) to lateral branch nerve block for SIJ
    Intervention: Other: Beighton score for hypermobility
  • Greater trochanter injection
    Positive response (>50% pain relief) to greater trochanteric bursa injection
    Intervention: Other: Beighton score for hypermobility
  • Piriformis injection
    Positive response (>50% pain relief) to piriformis injection
    Intervention: Other: Beighton score for hypermobility
  • Trigger point injection
    Positive response (>50% pain relief) to trigger point injection
    Intervention: Other: Beighton score for hypermobility
Publications * Grahame R. Joint hypermobility syndrome pain. Curr Pain Headache Rep. 2009 Dec;13(6):427-33. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: May 3, 2016)
2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2025
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02761928
Other Study ID Numbers HSC-MS-15-0809
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Mark J Burish, The University of Texas Health Science Center, Houston
Study Sponsor The University of Texas Health Science Center, Houston
Collaborators Not Provided
Investigators
Principal Investigator: Mark Burish, MD PhD The University of Texas Health Science Center, Houston
PRS Account The University of Texas Health Science Center, Houston
Verification Date October 2018