NCT02580383

Brief Summary

The investigators collected data and chart from the patients who were diagnosed facet joint syndrome and underwent lumbar RF medial branch neurotomy between January 2009 and June 2014. RF was performed using sensory stimulation and multifidus twitching to confirm the position of RF needle. The patients wil be grouped according to the adequacy of RF needle position while performing RF medial branch neurotomy ('complete' when all needles were placed adequately, 'partial' when one of the needles for a facet joint medial branch was placed inadequately, 'none' when there were both needles positioned inadequately for a facet joint) The relationship between the long term effect of RF neurotomy (longer than 6 months) and the groups will be analyzed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

September 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 20, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 23, 2016

Status Verified

June 1, 2016

Enrollment Period

9 months

First QC Date

October 18, 2015

Last Update Submit

June 21, 2016

Conditions

Facet Joint Syndrome

Keywords

Radiofrequency ablationRF-MBLumbar RFFacet joint syndromeMultifidus twitchingSensory stimulation

Outcome Measures

Primary Outcomes (1)

  • Long term effective duration

    Duration of pain score less than half of initial pain score

    1 years

Study Arms (3)

Group none

According to the adequacy of RF needle position while performing radiofrequency neurotomy of lumbar medial branch. When both needles were positioned inadequately for a facet joint.

Procedure: Radiofrequency neurotomy of lumbar medial branch

Group partial

According to the adequacy of RF needle position while performing radiofrequency neurotomy of lumbar medial branch. when one of the needles for a facet joint medial branch was placed inadequately.

Procedure: Radiofrequency neurotomy of lumbar medial branch

Group complete

According to the adequacy of RF needle position while performing radiofrequency neurotomy of lumbar medial branch. When all needles were placed adequately.'

Procedure: Radiofrequency neurotomy of lumbar medial branch

Interventions

Radiofrequency neurotomy of lumbar medial branchPROCEDURE

In above L5, The RF needle was placed to contact with bone as close as possible to the course of the target nerve in parallel. For L5 dorsal rami ablation, the needle was positioned in the groove between the S1 articular process and sacral ala. At each level, the electrodes were adjusted to optimize sensory stimulation at a frequency of 50 Hz and maximize multifidus contraction at 2 Hz. A 75 second 80°C lesion was made using an RF generator.

Also known as: Lumbar RF neurotomy
Group completeGroup noneGroup partial

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients who had lumbar back pain in Gangnam Severance hospital, Seoul, Republic of Korea.

You may qualify if:

  • All the patients who were diagnosed facet joint syndrome and underwent lumbar RF medial branch neurotomy between January 2009 and June 2014.

You may not qualify if:

  • absence of 12-month follow-up data, the patients who underwent RF medial branch neurotomy on bilateral side or the patients who underwent surgery or other interventional procedures that might affect pain derived from lumbar facet joint during the follow-up period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gangnam Severance Hospital

Seoul, Gangnam-gu, 135-720, South Korea

Location

Related Publications (2)

  • Cohen SP, Strassels SA, Kurihara C, Griffith SR, Goff B, Guthmiller K, Hoang HT, Morlando B, Nguyen C. Establishing an optimal "cutoff" threshold for diagnostic lumbar facet blocks: a prospective correlational study. Clin J Pain. 2013 May;29(5):382-91. doi: 10.1097/AJP.0b013e31825f53bf.

    PMID: 23023310BACKGROUND

  • Cohen SP, Strassels SA, Kurihara C, Lesnick IK, Hanling SR, Griffith SR, Buckenmaier CC 3rd, Nguyen C. Does sensory stimulation threshold affect lumbar facet radiofrequency denervation outcomes? A prospective clinical correlational study. Anesth Analg. 2011 Nov;113(5):1233-41. doi: 10.1213/ANE.0b013e31822dd379. Epub 2011 Sep 14.

    PMID: 21918166BACKGROUND

Study Officials

  • Yoon-Woo Lee, MD, PhD

    Department of Anesthesiology and Pain medicine, Gangnam Severance Hospital, Seoul, Korea

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical fellow

Study Record Dates

First Submitted

October 18, 2015

First Posted

October 20, 2015

Study Start

September 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

June 23, 2016

Record last verified: 2016-06

Locations

KR(1)