Facet Joint SyndromeNCT02580383
Multifidus Muscle Twitch on the Prognosis of Lumbar Medial Branch RF
An observational study of Facet Joint Syndrome, run by Severance Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Facet Joint Syndrome
- What is being tested?
- Radiofrequency neurotomy of lumbar medial branch
- Type of treatment
- Surgery or procedure
- How many people
- 68 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2015to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients who had lumbar back pain in Gangnam Severance hospital, Seoul, Republic of Korea.
Who may be able to join
- All the patients who were diagnosed facet joint syndrome and underwent lumbar RF medial branch neurotomy between January 2009 and June 2014.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Multifidus Muscle Twitch on the Long Term Effect of Radiofrequency Lumbar Medial Branch Neurotomy
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.
Read the 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.
- Conditions
- Facet Joint Syndrome
- Being tested
- Radiofrequency neurotomy of lumbar medial branch
- Keywords
- Radiofrequency ablation, RF-MB, Lumbar RF, Facet joint syndrome, Multifidus twitching, Sensory stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency neurotomy of lumbar medial branchProcedure or surgery
Also called Lumbar RF neurotomy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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.' Receives: Procedure: Radiofrequency neurotomy of lumbar medial branch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term effective duration
Duration of pain score less than half of initial pain score
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Facet Joint SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Koh, Jae Chul, MD, Severance Hospital
- Investigators
- Yoon-Woo Lee, MD, PhD, Study chair, Department of Anesthesiology and Pain medicine, Gangnam Severance Hospital, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580383
- Sponsor's protocol ID
- 2015-0385-001
- Status last verified
- Jun 2016
- First submitted
- 18 Oct 2015
- Last updated
- 23 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23023310Cohen 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.
PubMed 21918166
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Multifidus Muscle Twitch on the Long Term Effect of Radiofrequency Lumbar Medial Branch Neurotomy
- ClinicalTrials.gov ID
- NCT02580383
- Acronym / sponsor ID
- 2015-0385-001
- Conditions
- Facet Joint Syndrome
- Keywords
- Radiofrequency ablation, RF-MB, Lumbar RF, Facet joint syndrome, Multifidus twitching, Sensory stimulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Severance HospitalUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 20 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group none | – | Procedure: Radiofrequency neurotomy of lumbar medial branchAccording 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. |
| Group partial | – | Procedure: Radiofrequency neurotomy of lumbar medial branchAccording 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. |
| Group complete | – | Procedure: Radiofrequency neurotomy of lumbar medial branchAccording to the adequacy of RF needle position while performing radiofrequency neurotomy of lumbar medial branch. When all needles were placed adequately.' |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients who had lumbar back pain in Gangnam Severance hospital, Seoul, Republic of Korea.
Key inclusion criteria (1 listed)
- All the patients who were diagnosed facet joint syndrome and underwent lumbar RF medial branch neurotomy between January 2009 and June 2014.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency neurotomy of lumbar medial branchAlso: Lumbar RF neurotomyIn 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. | Procedure or surgery | Group complete, Group none, Group partial |
Primary outcome
Long term effective duration
Time frame: 1 years
Duration of pain score less than half of initial pain score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2016.
- Background: PubMed 23023310Cohen 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.
- Background: PubMed 21918166Cohen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoon-Woo Lee, MD, PhD study chair
Department of Anesthesiology and Pain medicine, Gangnam Severance Hospital, Seoul, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Facet Joint Syndrome, run by Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long term effective duration (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02580383, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2016.