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Value of Functional Anesthetic and Provocative Discography in the Surgical Treatment of Discogenic Pain

Primary Purpose

Discogenic Pain, Low Back Pain

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Functional anesthetic discography
Provocative Discography
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Discogenic Pain focused on measuring low back pain, spinal fusion, Primarily axial low back pain

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age between 21 to 65 years.
  2. Symptoms of at least 6 months duration.
  3. Primarily axial low back pain.
  4. At least 6 months of conservative treatment, including, physical therapy, injections, chiropractic etc.
  5. Patients with overall pain scores of greater than 6/10 (NRS).
  6. Recent (within the past 6 months) lumbar spine MRI showing: disc desiccation and loss of disc height of at least one disc level.

Exclusion Criteria:

  1. History of previous spine surgery.
  2. MRI changes at more than two disc levels on the recent (within the past 6 months) lumbar spine MRI.

  3. Clinical or radiological evidence of significant:

    1. Disc herniation
    2. Spinal Stenosis
    3. Spinal Deformity
    4. Spondylolisthesis
    5. Spinal instability or pars-defect
    6. Facet Syndrome
    7. Sacroiliac Joint Dysfunction
    8. Myofascial Pain Syndrome
    9. Fibromyalgia

  4. Current issues of:

    1. Litigation
    2. Disability
    3. Drug addiction or substance abuse
    4. Chronic pain medication abuse
  5. Current diagnosis of and medication use for unstable anxiety, depression, and/or behavioral disorders.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Functional anesthetic discography

    Provocative Discography

    Arm Description

    The patients disc levels for surgical treatment will be based exclusively on their Functional anesthetic discography results. The discography will be performed at a maximum of two disc levels. Discs showing the following MRI findings will be considered for discography: Loss of disc signal intensity on T-2 weighted sagittal MR images. Loss of disc height on sagittal MR images. Patients will be followed-up at 3 weeks, 3 months, 6 months and 1 year after the surgery by research personnel. Patients will be asked to complete questionnaires before their discography and at every follow-up visit.

    The patients disc levels for surgical treatment will be based exclusively on their Provocative Discography results. The discography will be performed at a maximum of two disc levels. Discs showing the following MRI findings will be considered for discography: Loss of disc signal intensity on T-2 weighted sagittal MR images. Loss of disc height on sagittal MR images. The control disc, in the case provocative discography group must appear normal on the MRI - must have preserved disc height and central disc signal intensity on T-2 weighted images. The provocative discography will be performed using the standard IASP criteria. The patients will be followed-up at 3 weeks, 3 months, 6 months and 1 year after the surgery.

    Outcomes

    Primary Outcome Measures

    Pain
    Numerical Rating Scale (11-point numerical rating, 0-10, scale of pain intensity) Standard Morphine Equivalent intake

    Secondary Outcome Measures

    Physical functioning
    Oswestry Disability Index
    Quality of Life
    SF-36 health survey
    Patient Satisfaction
    Patient Global Impression of Change

    Full Information

    First Posted
    February 26, 2010
    Last Updated
    September 9, 2016
    Sponsor
    Northwestern University
    Collaborators
    Medtronic Spine LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01077947
    Brief Title
    Value of Functional Anesthetic and Provocative Discography in the Surgical Treatment of Discogenic Pain
    Official Title
    Comparing the Value of Functional Anesthetic and Provocative Discography in the Surgical Treatment of Discogenic Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Internal
    Study Start Date
    February 2010 (undefined)
    Primary Completion Date
    February 2014 (Anticipated)
    Study Completion Date
    February 2014 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Northwestern University
    Collaborators
    Medtronic Spine LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Although discography and spinal imaging techniques, either alone or in combination, are commonly used to diagnose discogenic pain, their exact role in predicting surgical results are poorly defined. Our aim in this study is to compare the ability of Functional anesthetic discography (FAD), and Provocative Discography (PD) to diagnose discogenic pain and to correctly identify the disc levels for the surgical treatment. Proper identification for disc levels should improve the overall results of surgery for this condition. Patients with discogenic pain have better outcomes if the disc levels for the fusion surgery are identified by using FAD compared to similar disc level identification by PD.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Discogenic Pain, Low Back Pain
    Keywords
    low back pain, spinal fusion, Primarily axial low back pain

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Functional anesthetic discography
    Arm Type
    Active Comparator
    Arm Description
    The patients disc levels for surgical treatment will be based exclusively on their Functional anesthetic discography results. The discography will be performed at a maximum of two disc levels. Discs showing the following MRI findings will be considered for discography: Loss of disc signal intensity on T-2 weighted sagittal MR images. Loss of disc height on sagittal MR images. Patients will be followed-up at 3 weeks, 3 months, 6 months and 1 year after the surgery by research personnel. Patients will be asked to complete questionnaires before their discography and at every follow-up visit.
    Arm Title
    Provocative Discography
    Arm Type
    Active Comparator
    Arm Description
    The patients disc levels for surgical treatment will be based exclusively on their Provocative Discography results. The discography will be performed at a maximum of two disc levels. Discs showing the following MRI findings will be considered for discography: Loss of disc signal intensity on T-2 weighted sagittal MR images. Loss of disc height on sagittal MR images. The control disc, in the case provocative discography group must appear normal on the MRI - must have preserved disc height and central disc signal intensity on T-2 weighted images. The provocative discography will be performed using the standard IASP criteria. The patients will be followed-up at 3 weeks, 3 months, 6 months and 1 year after the surgery.
    Intervention Type
    Procedure
    Intervention Name(s)
    Functional anesthetic discography
    Intervention Description
    Functional anesthetic discography will be performed to diagnose discogenic pain and to correctly identify the disc levels for the surgical treatment. Proper identification for disc levels should improve the overall results of surgery for this condition.
    Intervention Type
    Procedure
    Intervention Name(s)
    Provocative Discography
    Intervention Description
    Provocative Discography will be performed to diagnose discogenic pain and to correctly identify the disc levels for the surgical treatment. Proper identification for disc levels should improve the overall results of surgery for this condition.
    Primary Outcome Measure Information:
    Title
    Pain
    Description
    Numerical Rating Scale (11-point numerical rating, 0-10, scale of pain intensity) Standard Morphine Equivalent intake
    Time Frame
    One Year
    Secondary Outcome Measure Information:
    Title
    Physical functioning
    Description
    Oswestry Disability Index
    Time Frame
    One Year
    Title
    Quality of Life
    Description
    SF-36 health survey
    Time Frame
    One Year
    Title
    Patient Satisfaction
    Description
    Patient Global Impression of Change
    Time Frame
    One Year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age between 21 to 65 years. Symptoms of at least 6 months duration. Primarily axial low back pain. At least 6 months of conservative treatment, including, physical therapy, injections, chiropractic etc. Patients with overall pain scores of greater than 6/10 (NRS). Recent (within the past 6 months) lumbar spine MRI showing: disc desiccation and loss of disc height of at least one disc level. Exclusion Criteria: History of previous spine surgery. MRI changes at more than two disc levels on the recent (within the past 6 months) lumbar spine MRI. Clinical or radiological evidence of significant: Disc herniation Spinal Stenosis Spinal Deformity Spondylolisthesis Spinal instability or pars-defect Facet Syndrome Sacroiliac Joint Dysfunction Myofascial Pain Syndrome Fibromyalgia Current issues of: Litigation Disability Drug addiction or substance abuse Chronic pain medication abuse Current diagnosis of and medication use for unstable anxiety, depression, and/or behavioral disorders.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Khalid Malik, M.D.
    Organizational Affiliation
    Department of Anesthesiology, Northwestern University, Feinberg School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Value of Functional Anesthetic and Provocative Discography in the Surgical Treatment of Discogenic Pain

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