Multifidus Muscle Twitch on the Prognosis of Lumbar Medial Branch RF

Sponsor
Severance Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02580383
Collaborator
(none)
68
1
9
7.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Radiofrequency neurotomy of lumbar medial branch

Detailed Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
68 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Effect of the Multifidus Muscle Twitch on the Long Term Effect of Radiofrequency Lumbar Medial Branch Neurotomy
Study Start Date :
Sep 1, 2015
Actual Primary Completion Date :
Jun 1, 2016
Actual Study Completion Date :
Jun 1, 2016

Arms and Interventions

Arm Intervention/Treatment
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
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.
Other Names:
  • Lumbar RF neurotomy
  • 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
    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.
    Other Names:
  • Lumbar RF neurotomy
  • 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
    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.
    Other Names:
  • Lumbar RF neurotomy
  • Outcome Measures

    Primary Outcome Measures

    1. Long term effective duration [1 years]

      Duration of pain score less than half of initial pain score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gangnam Severance Hospital Seoul Gangnam-gu Korea, Republic of 135-720

    Sponsors and Collaborators

    • Severance Hospital

    Investigators

    • Study Chair: Yoon-Woo Lee, MD, PhD, Department of Anesthesiology and Pain medicine, Gangnam Severance Hospital, Seoul, Korea

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Dr. Koh, Jae Chul, MD, Clinical fellow, Severance Hospital
    ClinicalTrials.gov Identifier:
    NCT02580383
    Other Study ID Numbers:
    • 2015-0385-001
    First Posted:
    Oct 20, 2015
    Last Update Posted:
    Jun 23, 2016
    Last Verified:
    Jun 1, 2016
    Keywords provided by Dr. Koh, Jae Chul, MD, Clinical fellow, Severance Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 23, 2016