Open Facet Joint Denervation in the Treatment of Low Back Pain

NCT ID: NCT03487120

Last Updated: 2023-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-26

Study Completion Date

2017-04-11

Brief Summary

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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

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Conditions

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Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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lumbar laminectomy

Group Type NO_INTERVENTION

No interventions assigned to this group

lumbar laminectomy with denervation of the facet joint

Group Type ACTIVE_COMPARATOR

facet joint denervation

Intervention Type PROCEDURE

Bipolar electrocautery

Interventions

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facet joint denervation

Bipolar electrocautery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queen's University

OTHER

Sponsor Role lead

Responsible Party

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Dr. David Yen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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NCTO

Identifier Type: -

Identifier Source: org_study_id

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