Open Facet Joint Denervation in the Treatment of Low Back Pain

Open Facet Joint Denervation in the Treatment of Low Back Pain -A Randomized Control Trial.

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.

Study Overview

• Status: Completed
• Conditions: Back Pain
• Intervention / Treatment: Procedure: facet joint denervation

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: lumbar laminectomy
Active Comparator: lumbar laminectomy with denervation of the facet joint	Procedure: facet joint denervation; Bipolar electrocautery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	change from baseline score at 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	change from baseline score at 24 weeks

Collaborators and Investigators

• Sponsor: Queen's University

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2016
• Primary Completion (Actual): April 10, 2017
• Study Completion (Actual): April 11, 2017

Study Registration Dates

• First Submitted: March 23, 2018
• First Submitted That Met QC Criteria: April 2, 2018
• First Posted (Actual): April 3, 2018

Study Record Updates

• Last Update Posted (Actual): April 10, 2023
• Last Update Submitted That Met QC Criteria: April 7, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: NCTO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No