Clinical trial NCT01300715: An Alternative Technique for Lumbar Medial Branch Radiofrequency: Comparison With the Empirical Technique
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Lumbar Facet Joint Pain
Arthropathy
Keywords: zygapophysial joint
facet joint
low back pain
radiofrequency
neurotomy
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2011-02-23
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

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

Primary outcomes:
measure: numerical rating scale (NRS)(1)
timeFrame: change from baseline in NRS at 4 weeks
Secondary outcomes:
measure: Oswestry Disability Index (ODI)(1)
timeFrame: change from baseline in ODI at 4 weeks
measure: time to complete the procedures
timeFrame: on procedure
measure: 7-point global perceived effect (GPE) scale about low back pain (1)
timeFrame: change from baseline in GPE scale at 4 weeks after the procedure
measure: Complication (1)
timeFrame: at one-month follow-up visit
measure: medication reduction (1)
timeFrame: baseline and 4 weeks
measure: NRS(3)
timeFrame: Change from baseline in NRS at 12 weeks
measure: procedure-related pain of numerical rating scale (NRS)
timeFrame: after 10 minutes following the procedure
measure: Oswestry Disability Index (ODI)(3)
timeFrame: change from baseline in ODI at 12 weeks
measure: 7-point global perceived effect (GPE) scale about low back pain (3)
timeFrame: change from baseline in GPE scale at 12 weeks after the procedure
measure: Complication (3)
timeFrame: at three-month follow-up visit
measure: medication reduction (3)
timeFrame: baseline and 12 weeks
measure: Volume of local anesthetic
timeFrame: on procedure
Other outcomes:
Locations:
city: Sungnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Kyonggi-do
Study officials:
References: