Open Facet Joint Denervation in the Treatment of Low Back Pain

Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03487120
• Other study ID #: NCTO
• Status: Completed
• Phase: N/A
• Start date: April 26, 2016
• Est. completion date: April 11, 2017

Study information

• Verified date: April 2023
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 11, 2017
• Est. primary completion date: April 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Procedure:
• facet joint denervation
Bipolar electrocautery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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