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

Low Back Pain Clinical Trial

— MBRF LBP  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01300715
• Other study ID #: MBRF
• Status: Recruiting
• Phase: N/A
• First received: January 31, 2011
• Last updated: February 22, 2011
• Start date: November 2010

Study information

• Verified date: October 2010
• Source: Seoul National University Bundang Hospital
• Contact: Jee Youn Moon, M.D.
• Phone: 82-10-5299-2036
• Email: snu23802[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Arthropathy
• Low Back Pain
• Lumbar Facet Joint Pain

Intervention

Procedure:
• lumbar medial branch radiofrequency neurotomy
the classic tunnel vision technique versus the alternative technique

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Sungnam	Kyonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	time to complete the procedures	Time required to complete each procedure (skin-to-lesion time, separately)	on procedure	No
Secondary	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	No
Secondary	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	Yes
Secondary	medication reduction (1)	doses of preprocedural analgesics versus postprocedural medication reduction	baseline and 4 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	medication reduction (3)	doses of preprocedural analgesics versus postprocedural medication reduction	baseline and 12 weeks	No
Secondary	Volume of local anesthetic	Volume of local anesthetic required for superficial and deep anesthesia, separately	on procedure	No