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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Seoul National University Bundang Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01300715
First received: January 31, 2011
Last updated: February 22, 2011
Last verified: October 2010
History of Changes
  Purpose

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.


Condition Intervention
Low Back Pain
Lumbar Facet Joint Pain
Arthropathy
 Procedure: lumbar medial branch radiofrequency neurotomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • numerical rating scale (NRS)(1) [ Time Frame: change from baseline in NRS at 4 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: change from baseline in ODI at 4 weeks ] [ Designated as safety issue: No ]
    Preprocedure Oswestry Disability Index (ODI) versus ODI at one-month follow-up visit

  • time to complete the procedures [ Time Frame: on procedure ] [ Designated as safety issue: No ]
    Time required to complete each procedure (skin-to-lesion time, separately)

  • 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 ] [ Designated as safety issue: No ]
    1. = worse than ever
    2. = much worsened
    3. = slightly worsened
    4. = unchanged
    5. = slightly improved
    6. = much improved
    7. = completely recovered

  • Complication (1) [ Time Frame: at one-month follow-up visit ] [ Designated as safety issue: Yes ]

    Complications associated to the procedures

    1. localized pain at radiofrequency sites
    2. neuritic pain
    3. a new sensory or motor deficit
    4. others

  • medication reduction (1) [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
    doses of preprocedural analgesics versus postprocedural medication reduction

  • NRS(3) [ Time Frame: Change from baseline in NRS at 12 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: after 10 minutes following the procedure ] [ Designated as safety issue: No ]
    Procedure-related pain as determined by NRS is recorded immediately after lumbar medial branch radiofrequency.

  • Oswestry Disability Index (ODI)(3) [ Time Frame: change from baseline in ODI at 12 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: change from baseline in GPE scale at 12 weeks after the procedure ] [ Designated as safety issue: No ]
    1. = worse than ever
    2. = much worsened
    3. = slightly worsened
    4. = unchanged
    5. = slightly improved
    6. = much improved
    7. = completely recovered

  • Complication (3) [ Time Frame: at three-month follow-up visit ] [ Designated as safety issue: Yes ]

    Complications associated to the procedures

    1. localized pain at radiofrequency sites
    2. neuritic pain
    3. a new sensory or motor deficit
    4. others

  • medication reduction (3) [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
    doses of preprocedural analgesics versus postprocedural medication reduction

  • Volume of local anesthetic [ Time Frame: on procedure ] [ Designated as safety issue: No ]
    Volume of local anesthetic required for superficial and deep anesthesia, separately


Estimated Enrollment: 100
Study Start Date: November 2010
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MBRF Procedure: lumbar medial branch radiofrequency neurotomy
the classic tunnel vision technique versus the alternative technique

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01300715

Contacts
Contact: Jee Youn Moon, M.D. 82-10-5299-2036 snu23802@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Sungnam, Kyonggi-do, Korea, Republic of, 463-707
Contact: Pyung-Bok Lee, M.D., Ph.D.            
Sponsors and Collaborators
Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Jeeyoun Moon, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01300715     History of Changes
Other Study ID Numbers: MBRF
Study First Received: January 31, 2011
Last Updated: February 22, 2011
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Bundang Hospital:
zygapophysial joint
facet joint
low back pain
radiofrequency
neurotomy

Additional relevant MeSH terms:
Arthralgia
Back Pain
Joint Diseases
Low Back Pain
Musculoskeletal Diseases
 Pain
Signs and Symptoms
Neurologic Manifestations
Nervous System Diseases

ClinicalTrials.gov processed this record on June 18, 2013