Clinical trial NCT02580383: Multifidus Muscle Twitch on the Prognosis of Lumbar Medial Branch RF
Official title: Effect of the Multifidus Muscle Twitch on the Long Term Effect of Radiofrequency Lumbar Medial Branch Neurotomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Facet Joint Syndrome
Keywords: Radiofrequency ablation
RF-MB
Lumbar RF
Facet joint syndrome
Multifidus twitching
Sensory stimulation
Lead sponsor: Severance Hospital
Sponsor class: OTHER
First posted: 2015-10-20
Enrollment: 68
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients who had lumbar back pain in Gangnam Severance hospital, Seoul, Republic of Korea.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Long term effective duration
timeFrame: 1 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
state: Gangnam-gu
Study officials:
affiliation: Department of Anesthesiology and Pain medicine, Gangnam Severance Hospital, Seoul, Korea
name: Yoon-Woo Lee, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.