Low Back PainMBRF LBPNCT01300715
An Alternative Technique for Lumbar Medial Branch Radiofrequency: Comparison With the Empirical Technique
A study testing lumbar medial branch radiofrequency neurotomy in people with Low Back Pain and Lumbar Facet Joint Pain, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
In spite that variable techniques for lumbar MBRF exists, the tunnel vision technique is widely recommended for exact radiofrequency needle placement. However, this method uses the concept of a steep caudocephalad axial tilt of the fluoroscopy beam, which result in unusual appearance of vertebral structures and a long… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Low Back Pain, Lumbar Facet Joint Pain, Arthropathy
- What is being tested?
- lumbar medial branch radiofrequency neurotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2010to May 2011
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic low back pain patients (pain duration > 6 months) who had not responded to previous treatment, underwent screening medial branch blocks (MBBs) using 0.5% levobupivacaine hydrochloride (Chirocaine®, Abbott Korea Ltd, Seoul, Republic of Korea) 0.5 mL at each of the standard target points.8 Patients that achieved at least 80% pain relief by screening MBBs underwent controlled comparative local anesthetic blocks using 1% lidocaine (0.5 mL) and 0.5% levobupivacaine (0.5 mL). Those that achieved greater than 80% pain relief following double blocks were eligible for lumbar MBRF, but those with prolonged responses to screening or dual-controlled comparative MBBs were not considered eligible.
Who cannot join
- Duration of low back pain < 6 mo
- Single diagnostic block
- Prolonged responses to screening or dual-controlled comparative MBBs
- Discogenic pain verified by controlled discography
- Evidence of radiculopathy, as determined by history, physical examination, and radiologic studies
- Structural lumbar spinal deformity
Show all 9Show fewer
- Rapidly worsening pain, numbness, weakness, hyperreflexia, changes in bladder function, and other neurological symptoms which should prompt a reevaluation and surgical evaluation.
- Previous back surgery
- Severe psychiatric illness
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Sungnam, Kyonggi-do, 463-707
Pyung-Bok Lee, M.D., Ph.D.
About this study
In spite that variable techniques for lumbar MBRF exists, the tunnel vision technique is widely recommended for exact radiofrequency needle placement. However, this method uses the concept of a steep caudocephalad axial tilt of the fluoroscopy beam, which result in unusual appearance of vertebral structures and a long distance from skin to the target site. In our institution, therefore, the investigators have used a modified method that is easy and safe to place RF needle parallel to the lumbar medial branch in oblique fluoroscopic view.
Accordingly, our objectives were to evaluate our modified technique for lumbar MBRF, comparing with the tunnel vision technique, and additionally to assess complications with respect to these two techniques.
Read the detailed description
The zygapophysial (facet) joint pain has been a challenging condition for pain specialists since the 20th century. According to the previous reports, degenerative changes of facet joint account for 10% - 15% of the cases with chronic low back pain. However, it is a major source of frustration that there is no definitive standard to document a clinical diagnosis and few validated treatment about lumbar facet joint pain.
Although it has been a subject of debate how best to select patients, radiofrequency (RF) neurotomy is frequently performed procedure for patients with lumbar facet generated pain. Lumbar medial branch radiofrequency (MBRF) is assumed to be effective and safe treatment for lumbar facet joint pain with 1.0% rate of minor complications per lesion site. The rationale and efficacy of lumbar MBRF would depend on the use of meticulous radiofrequency (RF) needle placement with stringent patient selection.
In spite that variable techniques for lumbar MBRF exists, the tunnel vision technique is widely recommended for exact RF needle placement. However, this method uses the concept of a steep caudocephalad axial tilt of the fluoroscopy beam, which result in unusual appearance of vertebral structures and a long distance from skin to the target site. In our institution, therefore, the investigators have used a modified method that is easy and safe to place RF needle parallel to the lumbar medial branch in oblique fluoroscopic view.
Accordingly, our objectives were to evaluate our modified technique for lumbar MBRF, comparing with the tunnel vision technique, and additionally to assess complications with respect to these two techniques.
- Conditions
- Low Back Pain, Lumbar Facet Joint Pain, Arthropathy
- Being tested
- lumbar medial branch radiofrequency neurotomy
- Keywords
- zygapophysial joint, facet joint, low back pain, radiofrequency, neurotomy
- Medical subject headings
- Low Back Pain, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumbar medial branch radiofrequency neurotomyProcedure or surgery
the classic tunnel vision technique versus the alternative technique
| Study group | Role | What they receive |
|---|---|---|
| MBRF | Active comparator | Not described Receives: Procedure: lumbar medial branch radiofrequency neurotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
numerical rating scale (NRS)(1)
Preprocedure low-back pain recorded on a 0 to 10 numerical rating scale (NRS)versus NRS at one-month follow-up visits
Measured: change from baseline in NRS at 4 weeks
Secondary outcomes (12)
Oswestry Disability Index (ODI)(1)
Preprocedure Oswestry Disability Index (ODI) versus ODI at one-month follow-up visit
Measured: change from baseline in ODI at 4 weeks
time to complete the procedures
Time required to complete each procedure (skin-to-lesion time, separately)
Measured: on procedure
7-point global perceived effect (GPE) scale about low back pain (1)
- = worse than ever
- = much worsened
- = slightly worsened
- = unchanged
- = slightly improved
- = much improved
- = completely recovered
Measured: change from baseline in GPE scale at 4 weeks after the procedure
Complication (1)
Complications associated to the procedures
- localized pain at radiofrequency sites
- neuritic pain
- a new sensory or motor deficit
- others
Measured: at one-month follow-up visit
medication reduction (1)
doses of preprocedural analgesics versus postprocedural medication reduction
Measured: baseline and 4 weeks
NRS(3)
preprocedural low back pain recorded on a 0 to 10 numerical rating scale versus NRS at a 3-month follow-up visit
Measured: Change from baseline in NRS at 12 weeks
procedure-related pain of numerical rating scale (NRS)
Procedure-related pain as determined by NRS is recorded immediately after lumbar medial branch radiofrequency.
Measured: after 10 minutes following the procedure
Oswestry Disability Index (ODI)(3)
Preprocedure Oswestry Disability Index (ODI) versus ODI at three-month follow-up visit
Measured: change from baseline in ODI at 12 weeks
7-point global perceived effect (GPE) scale about low back pain (3)
- = worse than ever
- = much worsened
- = slightly worsened
- = unchanged
- = slightly improved
- = much improved
- = completely recovered
Measured: change from baseline in GPE scale at 12 weeks after the procedure
Complication (3)
Complications associated to the procedures
- localized pain at radiofrequency sites
- neuritic pain
- a new sensory or motor deficit
- others
Measured: at three-month follow-up visit
medication reduction (3)
doses of preprocedural analgesics versus postprocedural medication reduction
Measured: baseline and 12 weeks
Volume of local anesthetic
Volume of local anesthetic required for superficial and deep anesthesia, separately
Measured: on procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startNov 2010
- Primary completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01300715
- Sponsor's protocol ID
- MBRF
- Acronym
- MBRF LBP
- Status last verified
- Oct 2010
- First submitted
- 31 Jan 2011
- Last updated
- 23 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Alternative Technique for Lumbar Medial Branch Radiofrequency: Comparison With the Empirical Technique
- ClinicalTrials.gov ID
- NCT01300715
- Acronym / sponsor ID
- MBRF LBP / MBRF
- Conditions
- Low Back Pain, Lumbar Facet Joint Pain, Arthropathy
- Keywords
- zygapophysial joint, facet joint, low back pain, radiofrequency, neurotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- May 2011 (estimated)
- First posted
- 23 Feb 2011 (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.
In spite that variable techniques for lumbar MBRF exists, the tunnel vision technique is widely recommended for exact radiofrequency needle placement. However, this method uses the concept of a steep caudocephalad axial tilt of the fluoroscopy beam, which result in unusual appearance of vertebral structures and a long distance from skin to the target site. In our institution, therefore, the investigators have used a modified method that is easy and safe to place RF needle parallel to the lumbar medial branch in oblique fluoroscopic view.
Accordingly, our objectives were to evaluate our modified technique for lumbar MBRF, comparing with the tunnel vision technique, and additionally to assess complications with respect to these two techniques.
Detailed description
The zygapophysial (facet) joint pain has been a challenging condition for pain specialists since the 20th century. According to the previous reports, degenerative changes of facet joint account for 10% - 15% of the cases with chronic low back pain. However, it is a major source of frustration that there is no definitive standard to document a clinical diagnosis and few validated treatment about lumbar facet joint pain.
Although it has been a subject of debate how best to select patients, radiofrequency (RF) neurotomy is frequently performed procedure for patients with lumbar facet generated pain. Lumbar medial branch radiofrequency (MBRF) is assumed to be effective and safe treatment for lumbar facet joint pain with 1.0% rate of minor complications per lesion site. The rationale and efficacy of lumbar MBRF would depend on the use of meticulous radiofrequency (RF) needle placement with stringent patient selection.
In spite that variable techniques for lumbar MBRF exists, the tunnel vision technique is widely recommended for exact RF needle placement. However, this method uses the concept of a steep caudocephalad axial tilt of the fluoroscopy beam, which result in unusual appearance of vertebral structures and a long distance from skin to the target site. In our institution, therefore, the investigators have used a modified method that is easy and safe to place RF needle parallel to the lumbar medial branch in oblique fluoroscopic view.
Accordingly, our objectives were to evaluate our modified technique for lumbar MBRF, comparing with the tunnel vision technique, and additionally to assess complications with respect to these two techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MBRF | Active comparator | Procedure: lumbar medial branch radiofrequency neurotomy |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic low back pain patients (pain duration > 6 months) who had not responded to previous treatment, underwent screening medial branch blocks (MBBs) using 0.5% levobupivacaine hydrochloride (Chirocaine®, Abbott Korea Ltd, Seoul, Republic of Korea) 0.5 mL at each of the standard target points.8 Patients that achieved at least 80% pain relief by screening MBBs underwent controlled comparative local anesthetic blocks using 1% lidocaine (0.5 mL) and 0.5% levobupivacaine (0.5 mL). Those that achieved greater than 80% pain relief following double blocks were eligible for lumbar MBRF, but those with prolonged responses to screening or dual-controlled comparative MBBs were not considered eligible.
Key exclusion criteria (9 listed)
- Duration of low back pain < 6 mo
- Single diagnostic block
- Prolonged responses to screening or dual-controlled comparative MBBs
- Discogenic pain verified by controlled discography
- Evidence of radiculopathy, as determined by history, physical examination, and radiologic studies
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 |
|---|---|---|
| lumbar medial branch radiofrequency neurotomythe classic tunnel vision technique versus the alternative technique | Procedure or surgery | MBRF |
Primary outcome
numerical rating scale (NRS)(1)
Time frame: change from baseline in NRS at 4 weeks
Preprocedure low-back pain recorded on a 0 to 10 numerical rating scale (NRS)versus NRS at one-month follow-up visits
12 secondary outcomes
Oswestry Disability Index (ODI)(1)
Time frame: change from baseline in ODI at 4 weeks
time to complete the procedures
Time frame: on procedure
7-point global perceived effect (GPE) scale about low back pain (1)
Time frame: change from baseline in GPE scale at 4 weeks after the procedure
Complication (1)
Time frame: at one-month follow-up visit
medication reduction (1)
Time frame: baseline and 4 weeks
NRS(3)
Time frame: Change from baseline in NRS at 12 weeks
procedure-related pain of numerical rating scale (NRS)
Time frame: after 10 minutes following the procedure
Oswestry Disability Index (ODI)(3)
Time frame: change from baseline in ODI at 12 weeks
7-point global perceived effect (GPE) scale about low back pain (3)
Time frame: change from baseline in GPE scale at 12 weeks after the procedure
Complication (3)
Time frame: at three-month follow-up visit
medication reduction (3)
Time frame: baseline and 12 weeks
Volume of local anesthetic
Time frame: on procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lumbar medial branch radiofrequency neurotomy in people with Low Back Pain and Lumbar Facet Joint Pain, run by Seoul National University Bundang 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 9 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: status not confirmed, as of the sponsor's last update on 23 Feb 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jee Youn Moon, M.D. (82-10-5299-2036, snu23802@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
numerical rating scale (NRS)(1) (time frame: change from baseline in NRS at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2011.