About this trial
The purpose of this voluntary research study is to determine whether the parasagittal approach to lumbar medial branch (LMB) nerve radio frequency ablation (RFA) will have greater efficacy than the traditional approach to lumbar medial branch nerve radio frequency ablation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Bilateral equally intense axial low back pain
Pain duration of ≥ 6 months
Three-day average NRS scores of ≥ 3/10
Age greater than 18 years
Disqualifiers
Radicular pain below the knee
Systemic infection or localized infection at the anticipated introducer entry site
Pregnancy
Allergy to Lidocaine
Trial design
Parallel
Treatments tested in this trial
Radiofrequency ablation of lumbar medial branch nerves.
Procedure/SurgeryTraditional approach: The electrode is introduced at a 15-20 degrees' ipsilateral oblique angle to the sagittal plane toward the junction of the superior articular process (SAP) and transverse process (TP) of the vertebral body to target the traversing medial branch nerve. Parasagittal (new) approach: The RF cannula is placed parasagittally and more dorsally. The remainder of the procedure does not differ from the traditional method.
Treatment groups
Trial outcomes
Primary outcomes
The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores).
The patients will describe the pain intensity using NRS - 11-point numeric rating scale, with 0 means no pain, and 10 - the worst possible pain intensity.
The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores).
The patients will describe the pain intensity using NRS - 11-point numeric rating scale, with 0 means no pain, and 10 - the worst possible pain intensity.
The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores).
The patients will describe the pain intensity using NRS - 11-point numeric rating scale, with 0 means no pain, and 10 - the worst possible pain intensity.
Secondary outcomes
Oswestry Disability index (ODI)
10 questions assessing the functional impairment by the pain, using a 50 point scale, with 0 meaning no disability, and 50 meaning complete disability.
Oswestry Disability index (ODI)
10 questions assessing the functional impairment by the pain, using a 50 point scale, with 0 meaning no disability, and 50 meaning complete disability.
Oswestry Disability index (ODI)
10 questions assessing the functional impairment by the pain, using a 50 point scale, with 0 meaning no disability, and 50 meaning complete disability.
Other outcomes
Number of subjects who ceased requiring analgesia
The patients will self-report their analgesic consumption.
Number of subjects who ceased requiring analgesia
The patients will self-report their analgesic consumption.
Number of subjects who ceased requiring analgesia
The patients will self-report their analgesic consumption.
Sponsors and contacts
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