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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
the classic tunnel vision technique versus the alternative technique
Seoul National University Bundang Hospital
Sungnam, Kyonggi-do, South Korea
RECRUITINGnumerical 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
Time frame: change from baseline in NRS at 4 weeks
Oswestry Disability Index (ODI)(1)
Preprocedure Oswestry Disability Index (ODI) versus ODI at one-month follow-up visit
Time frame: change from baseline in ODI at 4 weeks
time to complete the procedures
Time required to complete each procedure (skin-to-lesion time, separately)
Time frame: on procedure
7-point global perceived effect (GPE) scale about low back pain (1)
1. = worse than ever 2. = much worsened 3. = slightly worsened 4. = unchanged 5. = slightly improved 6. = much improved 7. = completely recovered
Time frame: change from baseline in GPE scale at 4 weeks after the procedure
Complication (1)
Complications associated to the procedures 1. localized pain at radiofrequency sites 2. neuritic pain 3. a new sensory or motor deficit 4. others
Time frame: at one-month follow-up visit
medication reduction (1)
doses of preprocedural analgesics versus postprocedural medication reduction
Time frame: 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
Time frame: 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.
Time frame: after 10 minutes following the procedure
Oswestry Disability Index (ODI)(3)
Preprocedure Oswestry Disability Index (ODI) versus ODI at three-month follow-up visit
Time frame: change from baseline in ODI at 12 weeks
7-point global perceived effect (GPE) scale about low back pain (3)
1. = worse than ever 2. = much worsened 3. = slightly worsened 4. = unchanged 5. = slightly improved 6. = much improved 7. = completely recovered
Time frame: change from baseline in GPE scale at 12 weeks after the procedure
Complication (3)
Complications associated to the procedures 1. localized pain at radiofrequency sites 2. neuritic pain 3. a new sensory or motor deficit 4. others
Time frame: at three-month follow-up visit
medication reduction (3)
doses of preprocedural analgesics versus postprocedural medication reduction
Time frame: baseline and 12 weeks
Volume of local anesthetic
Volume of local anesthetic required for superficial and deep anesthesia, separately
Time frame: on procedure
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