Open Facet Joint Denervation in the Treatment of Low Back Pain

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.

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Key information

Conditions

Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

facet joint denervation

Procedure

Bipolar electrocautery

Primary outcomes

Change in Visual analog scale for pain (VAS)

Time frame: 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 outcomes

Change in Modified Oswestry Disability score (ODI)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Apr 3, 2018
Registry last updated: Apr 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed