Open Facet Joint Denervation in the Treatment of Low Back Pain

Not Applicable

Completed

• Conditions: Back Pain
• Interventions: Procedure: facet joint denervation

• Registration Number: NCT03487120
• Lead Sponsor: Queen's University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-26
• Primary Completion: 2017-04-10
• Study Completion: 2017-04-11
• Study First Submitted: 2018-03-23
• Study First Submitted QC: 2018-04-02
• Study First Posted: 2018-04-03
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-07
• Last Update Posted: 2023-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lumbar laminectomy with denervation of the facet joint	facet joint denervation	-

Primary Outcome Measures

Name	Time	Method
Change in Visual analog scale for pain (VAS)	change from baseline score at 24 weeks	10 centimeter scale with a minimum of 0 indicating no pain and a maximum of 10 indicating worst pain.

Secondary Outcome Measures

Name	Time	Method
Change in Modified Oswestry Disability score (ODI)	change from baseline score at 24 weeks	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.