NCT03487120

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 26, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 3, 2018

Completed
Last Updated

April 10, 2023

Status Verified

April 1, 2023

Enrollment Period

12 months

First QC Date

March 23, 2018

Last Update Submit

April 7, 2023

Conditions

Back Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in Modified Oswestry Disability score (ODI)

    change from baseline score at 24 weeks

Study Arms (2)

lumbar laminectomy

NO INTERVENTION

lumbar laminectomy with denervation of the facet joint

ACTIVE COMPARATOR
Procedure: facet joint denervation

Interventions

facet joint denervationPROCEDURE

Bipolar electrocautery

lumbar laminectomy with denervation of the facet joint

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 19 or older
  • a diagnosis of spinal stenosis
  • having neurogenic claudication
  • complained of back pain for at least 3 months

You may not qualify if:

  • previous surgery on their spine,
  • fracture, systemic inflammatory disease,
  • malignancies or an infection affecting their spine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 23, 2018

First Posted

April 3, 2018

Study Start

April 26, 2016

Primary Completion

April 10, 2017

Study Completion

April 11, 2017

Last Updated

April 10, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share