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

NCT01300715 | Unknown DMC

• 1 other identifier: MBRF
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Lumbar Facet Joint Pain; Arthropathy

Keywords

zygapophysial joint; facet joint; low back pain; radiofrequency; neurotomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Oswestry Disability Index (ODI)(1)

  change from baseline in ODI at 4 weeks

• time to complete the procedures

  on procedure

• 7-point global perceived effect (GPE) scale about low back pain (1)

  change from baseline in GPE scale at 4 weeks after the procedure

• Complication (1)

  at one-month follow-up visit

• medication reduction (1)

  baseline and 4 weeks

Study Arms (1)

MBRF

ACTIVE COMPARATOR

Procedure: lumbar medial branch radiofrequency neurotomy

Interventions

lumbar medial branch radiofrequency neurotomy PROCEDURE

the classic tunnel vision technique versus the alternative technique

MBRF

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Sungnam, Kyonggi-do, 463-707, South Korea

RECRUITING

MeSH Terms

Conditions

Low Back Pain; Joint Diseases

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Musculoskeletal Diseases

Central Study Contacts

Jee Youn Moon, M.D.

CONTACT

82-10-5299-2036; snu23802@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 31, 2011
• First Posted: February 23, 2011
• Study Start: November 1, 2010
• Primary Completion: May 1, 2011
• Last Updated: February 23, 2011

Record last verified: 2010-10

Locations

KR (1)