Multifidus Muscle Twitch on the Prognosis of Lumbar Medial Branch RF

NCT ID: NCT02580383

Last Updated: 2016-06-23

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

Total Enrollment

68 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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Facet joint syndrome has been described as a common cause of lumbar back pain. To achieve prolonged therapeutic effect in patients with lumbar facet joint syndrome, radiofrequency (RF) medial branch neurotomy is commonly performed. When performing RF neurotomy, needle placement in correct position is very important. For this reason, identification of sensory stimulation and multifidus muscle twitching by using the electrode have been commonly performed. However, there were no previous reports regarding relationship between prognosis of RF neurotomy and multifidus muscle twitching in combination of sensory stimulation. The purpose of this study was to evaluate the prognostic value of multifidus twitching when sensory stimulation was achieved while performing RF needle neurotomy in patients with lumbar facet syndrome.

The investigators have 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. When numeric pain intensity score decreased less than half of the initial pain score, the procedure was regarded as effective and the duration was followed and recorded for each patients.

When multifidus twitching was observed in a voltage less than 1.0 to 2.0 times of the sensory stimulation (≤ 0.5V), the positioning of the RF needle will be regarded as adequate. The most appropriate cutoff value will be determined by univariate analysis. The patients will 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.

Conditions

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Facet Joint Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Radiofrequency neurotomy of lumbar medial branch

Intervention Type PROCEDURE

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.

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.

Radiofrequency neurotomy of lumbar medial branch

Intervention Type PROCEDURE

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.

Group complete

According to the adequacy of RF needle position while performing radiofrequency neurotomy of lumbar medial branch.

When all needles were placed adequately.'

Radiofrequency neurotomy of lumbar medial branch

Intervention Type PROCEDURE

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.

Interventions

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Radiofrequency neurotomy of lumbar medial branch

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.

Intervention Type PROCEDURE

Other Intervention Names

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Lumbar RF neurotomy

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr. Koh, Jae Chul, MD

Clinical fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yoon-Woo Lee, MD, PhD

Role: STUDY_CHAIR

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

Locations

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Gangnam Severance Hospital

Seoul, Gangnam-gu, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 23023310 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21918166 (View on PubMed)

Other Identifiers

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2015-0385-001

Identifier Type: -

Identifier Source: org_study_id

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