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

About this trial
This is an interventional treatment trial for Back Pain
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
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
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
Learn more about this trial
Open Facet Joint Denervation in the Treatment of Low Back Pain
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