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

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.

Study Overview

• Status: Unknown
• Conditions: Low Back Pain; Arthropathy; Lumbar Facet Joint Pain
• Intervention / Treatment: Procedure: lumbar medial branch radiofrequency neurotomy

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Kyonggi-do
    • Sungnam, Kyonggi-do, Korea, Republic of, 463-707
      • Recruiting
      • Seoul National University Bundang Hospital
      • Contact: Pyung-Bok Lee, M.D., Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MBRF	Procedure: lumbar medial branch radiofrequency neurotomy; the classic tunnel vision technique versus the alternative technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	change from baseline in NRS at 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index (ODI)(1)	Preprocedure Oswestry Disability Index (ODI) versus ODI at one-month follow-up visit	change from baseline in ODI at 4 weeks
time to complete the procedures	Time required to complete each procedure (skin-to-lesion time, separately)	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	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	at one-month follow-up visit
medication reduction (1)	doses of preprocedural analgesics versus postprocedural medication reduction	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	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.	after 10 minutes following the procedure
Oswestry Disability Index (ODI)(3)	Preprocedure Oswestry Disability Index (ODI) versus ODI at three-month follow-up visit	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	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	at three-month follow-up visit
medication reduction (3)	doses of preprocedural analgesics versus postprocedural medication reduction	baseline and 12 weeks
Volume of local anesthetic	Volume of local anesthetic required for superficial and deep anesthesia, separately	on procedure

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Anticipated): May 1, 2011

Study Registration Dates

• First Submitted: January 31, 2011
• First Submitted That Met QC Criteria: February 22, 2011
• First Posted (Estimate): February 23, 2011

Study Record Updates

• Last Update Posted (Estimate): February 23, 2011
• Last Update Submitted That Met QC Criteria: February 22, 2011
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: low back pain; radiofrequency; facet joint; zygapophysial joint; neurotomy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Back Pain; Low Back Pain
• Other Study ID Numbers: MBRF