search
Back to results

An Alternative Technique for Lumbar Medial Branch Radiofrequency: Comparison With the Empirical Technique (MBRF LBP)

Primary Purpose

Low Back Pain, Lumbar Facet Joint Pain, Arthropathy

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
lumbar medial branch radiofrequency neurotomy
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring zygapophysial joint, facet joint, low back pain, radiofrequency, neurotomy

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- 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.

Exclusion Criteria:

  1. Duration of low back pain < 6 mo
  2. Single diagnostic block
  3. Prolonged responses to screening or dual-controlled comparative MBBs
  4. Discogenic pain verified by controlled discography
  5. Evidence of radiculopathy, as determined by history, physical examination, and radiologic studies
  6. Structural lumbar spinal deformity
  7. Rapidly worsening pain, numbness, weakness, hyperreflexia, changes in bladder function, and other neurological symptoms which should prompt a reevaluation and surgical evaluation.
  8. Previous back surgery
  9. Severe psychiatric illness

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

MBRF

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Oswestry Disability Index (ODI)(1)
Preprocedure Oswestry Disability Index (ODI) versus ODI at one-month follow-up visit
time to complete the procedures
Time required to complete each procedure (skin-to-lesion time, separately)
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
Complication (1)
Complications associated to the procedures localized pain at radiofrequency sites neuritic pain a new sensory or motor deficit others
medication reduction (1)
doses of preprocedural analgesics versus postprocedural medication reduction
NRS(3)
preprocedural low back pain recorded on a 0 to 10 numerical rating scale versus NRS at a 3-month follow-up visit
procedure-related pain of numerical rating scale (NRS)
Procedure-related pain as determined by NRS is recorded immediately after lumbar medial branch radiofrequency.
Oswestry Disability Index (ODI)(3)
Preprocedure Oswestry Disability Index (ODI) versus ODI at three-month follow-up visit
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
Complication (3)
Complications associated to the procedures localized pain at radiofrequency sites neuritic pain a new sensory or motor deficit others
medication reduction (3)
doses of preprocedural analgesics versus postprocedural medication reduction
Volume of local anesthetic
Volume of local anesthetic required for superficial and deep anesthesia, separately

Full Information

First Posted
January 31, 2011
Last Updated
February 22, 2011
Sponsor
Seoul National University Bundang Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01300715
Brief Title
An Alternative Technique for Lumbar Medial Branch Radiofrequency: Comparison With the Empirical Technique
Acronym
MBRF LBP
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
May 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Lumbar Facet Joint Pain, Arthropathy
Keywords
zygapophysial joint, facet joint, low back pain, radiofrequency, neurotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MBRF
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
lumbar medial branch radiofrequency neurotomy
Intervention Description
the classic tunnel vision technique versus the alternative technique
Primary Outcome Measure Information:
Title
numerical rating scale (NRS)(1)
Description
Preprocedure low-back pain recorded on a 0 to 10 numerical rating scale (NRS)versus NRS at one-month follow-up visits
Time Frame
change from baseline in NRS at 4 weeks
Secondary Outcome Measure Information:
Title
Oswestry Disability Index (ODI)(1)
Description
Preprocedure Oswestry Disability Index (ODI) versus ODI at one-month follow-up visit
Time Frame
change from baseline in ODI at 4 weeks
Title
time to complete the procedures
Description
Time required to complete each procedure (skin-to-lesion time, separately)
Time Frame
on procedure
Title
7-point global perceived effect (GPE) scale about low back pain (1)
Description
= worse than ever = much worsened = slightly worsened = unchanged = slightly improved = much improved = completely recovered
Time Frame
change from baseline in GPE scale at 4 weeks after the procedure
Title
Complication (1)
Description
Complications associated to the procedures localized pain at radiofrequency sites neuritic pain a new sensory or motor deficit others
Time Frame
at one-month follow-up visit
Title
medication reduction (1)
Description
doses of preprocedural analgesics versus postprocedural medication reduction
Time Frame
baseline and 4 weeks
Title
NRS(3)
Description
preprocedural low back pain recorded on a 0 to 10 numerical rating scale versus NRS at a 3-month follow-up visit
Time Frame
Change from baseline in NRS at 12 weeks
Title
procedure-related pain of numerical rating scale (NRS)
Description
Procedure-related pain as determined by NRS is recorded immediately after lumbar medial branch radiofrequency.
Time Frame
after 10 minutes following the procedure
Title
Oswestry Disability Index (ODI)(3)
Description
Preprocedure Oswestry Disability Index (ODI) versus ODI at three-month follow-up visit
Time Frame
change from baseline in ODI at 12 weeks
Title
7-point global perceived effect (GPE) scale about low back pain (3)
Description
= worse than ever = much worsened = slightly worsened = unchanged = slightly improved = much improved = completely recovered
Time Frame
change from baseline in GPE scale at 12 weeks after the procedure
Title
Complication (3)
Description
Complications associated to the procedures localized pain at radiofrequency sites neuritic pain a new sensory or motor deficit others
Time Frame
at three-month follow-up visit
Title
medication reduction (3)
Description
doses of preprocedural analgesics versus postprocedural medication reduction
Time Frame
baseline and 12 weeks
Title
Volume of local anesthetic
Description
Volume of local anesthetic required for superficial and deep anesthesia, separately
Time Frame
on procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - 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. Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jee Youn Moon, M.D.
Phone
82-10-5299-2036
Email
snu23802@snu.ac.kr
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Sungnam
State/Province
Kyonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pyung-Bok Lee, M.D., Ph.D.

12. IPD Sharing Statement

Learn more about this trial

An Alternative Technique for Lumbar Medial Branch Radiofrequency: Comparison With the Empirical Technique

We'll reach out to this number within 24 hrs