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Open Facet Joint Denervation in the Treatment of Low Back Pain

Primary Purpose

Back Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
facet joint denervation
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • aged 19 or older
  • a diagnosis of spinal stenosis
  • having neurogenic claudication
  • complained of back pain for at least 3 months

Exclusion Criteria:

  • previous surgery on their spine,
  • fracture, systemic inflammatory disease,
  • malignancies or an infection affecting their spine

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    lumbar laminectomy

    lumbar laminectomy with denervation of the facet joint

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in Visual analog scale for pain (VAS)
    10 centimeter scale with a minimum of 0 indicating no pain and a maximum of 10 indicating worst pain.

    Secondary Outcome Measures

    Change in Modified Oswestry Disability score (ODI)
    The ODI is divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale. The range of scores is 0 to a maximum of 60. The total score is multiplied by 2 and expressed as a percentage. A score of 0 to 20 points indicates minimal disability; 20 to 40 points, moderate disability; and 40 to 60 points, severe disability.

    Full Information

    First Posted
    March 23, 2018
    Last Updated
    April 7, 2023
    Sponsor
    Queen's University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03487120
    Brief Title
    Open Facet Joint Denervation in the Treatment of Low Back Pain
    Official Title
    Open Facet Joint Denervation in the Treatment of Low Back Pain -A Randomized Control Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    April 26, 2016 (Actual)
    Primary Completion Date
    April 10, 2017 (Actual)
    Study Completion Date
    April 11, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Queen's University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A single blinded RCT for adult patients with spine pain. One group had a lumbar laminectomy with denervation of the facet joint at the level decompressed. The other group had a lumbar laminectomy without facet joint denervation. Both groups had their back pain and functional limitations measured using a 10 cm visual analogue scale and the Oswestry disability index (ODI). All measures were taken before surgery and at patients' 6, 12 and 24 week follow-up clinic visit.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Back Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    lumbar laminectomy
    Arm Type
    No Intervention
    Arm Title
    lumbar laminectomy with denervation of the facet joint
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    facet joint denervation
    Intervention Description
    Bipolar electrocautery
    Primary Outcome Measure Information:
    Title
    Change in Visual analog scale for pain (VAS)
    Description
    10 centimeter scale with a minimum of 0 indicating no pain and a maximum of 10 indicating worst pain.
    Time Frame
    change from baseline score at 24 weeks
    Secondary Outcome Measure Information:
    Title
    Change in Modified Oswestry Disability score (ODI)
    Description
    The ODI is divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale. The range of scores is 0 to a maximum of 60. The total score is multiplied by 2 and expressed as a percentage. A score of 0 to 20 points indicates minimal disability; 20 to 40 points, moderate disability; and 40 to 60 points, severe disability.
    Time Frame
    change from baseline score at 24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: aged 19 or older a diagnosis of spinal stenosis having neurogenic claudication complained of back pain for at least 3 months Exclusion Criteria: previous surgery on their spine, fracture, systemic inflammatory disease, malignancies or an infection affecting their spine

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Open Facet Joint Denervation in the Treatment of Low Back Pain

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