Clinical trial NCT06283628: Comparative Effectiveness of Two Different Approaches to Radiofrequency Ablation of Lumbar Medial Branch Nerves
Official title: Comparative Effectiveness of Two Different Approaches to Radiofrequency Ablation of Lumbar Medial Branch Nerves
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lumbar Spondylosis
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The subjects with bilateral low back pain will undergo radiofrequency ablation of the lumbar medial branch nerves using one approach (traditional) on one side and different approach (parasagittal) on the other side. One arm will use the traditional approach on the left and the parasagittal approach on the right. The other arm will use parasagittal approach on the left and the traditional approach on the right,
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: To determine whether the parasagittal approach to lumbar medial branch (LMB) nerve radiofrequency ablation (RFA) will have greater efficacy than the traditional approach to lumbar medial branch nerve radiofrequency ablation.

This will be accomplished by comparing the results between the newly proposed parasagittal approach and the traditional approach of medial branch RFA done on the same patient (different sites) with bilateral low back pain (LBP).

Traditional 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. The reason for the proposed angle is to avoid the mamillo-accessory ligament (MAL) that may be ossified in up to 10% of the normal spine and, in such cases, potentially prevent proper coagulation of the medial branch nerve during the RFA procedure.

Parasagittal (new) approach:

Recently, Tran et al. showed that MAL is located more dorsally than it was thought earlier and, therefore, can't interfere with nerve coagulation during the RFA. Consequently, they proposed abandoning the 20-degree angle used for the traditional approach and placing the radiofrequency cannula parasagittally and more dorsally. It is proposed that, in order to achieve maximum nerve coagulation, the electrode should be placed as parallel to the nerve as possible, and placing it parasagittally helps achieve this goal. The remainder of the procedure does not differ from the traditional method.

Eligibility criteria: Inclusion Criteria:

1. Bilateral equally intense axial low back pain
2. Pain duration of ≥ 6 months
3. Three-day average NRS scores of ≥ 3/10
4. Age greater than 18 years
5. Failure of conservative treatment, including nonsteroidal anti-inflammatory medications and physical therapy
6. Positive response to a series of two bilateral diagnostic lumbar medial branch nerve blocks (≥ 80% pain relief). This is the current standard of care.

Exclusion Criteria:

1. Radicular pain below the knee
2. Systemic infection or localized infection at the anticipated introducer entry site
3. Pregnancy
4. Allergy to Lidocaine
5. Bleeding dyscrasias
6. Patients unable to give informed consent
7. History of lumbar spine surgery at the affected levels
8. History of previous bilateral lumbar RFA of medial branches within the past six months.
9. Significant comorbid somatization or widespread pain with central sensitization
10. Secondary gain identified due to ongoing legal proceedings or worker's compensation
11. Cognitive impairment
12. Any pre-existing condition at the discretion of the provider that may confound interpretation of results -

Primary outcomes:
measure: The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores).
timeFrame: Baseline
measure: The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores).
timeFrame: 1 month post-procedure.
measure: The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores).
timeFrame: 6 months post-procedure.
Secondary outcomes:
measure: Oswestry Disability index (ODI)
timeFrame: Baseline
measure: Oswestry Disability index (ODI)
timeFrame: 1 month post-procedure.
measure: Oswestry Disability index (ODI)
timeFrame: 6 months post-procedure.
Other outcomes:
measure: Number of subjects who ceased requiring analgesia
timeFrame: Baseline
measure: Number of subjects who ceased requiring analgesia
timeFrame: 1 month post-procedure
measure: Number of subjects who ceased requiring analgesia
timeFrame: 6 months post-procedure
Locations:
city: Hershey
country: United States
facility: Penn State Hershey College of Medicine
state: Pennsylvania
Study officials:
affiliation: Professor, Department of Anesthesiology
name: Yakov Vorobeychik, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: