Comparative Effectiveness of Two Different Approaches to Radiofrequency Ablation of Lumbar Medial Branch Nerves
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores).
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
We will do computer randomization for the sides for each approach for all the subjects. The subjects will be assigned numbers, and the particular procedural approach for each side will be concealed in the numbered envelopes. The numbers on the envelopes will correspond to the numbers assigned to the patients. The envelopes will be opened by a treating physician in the procedure room. The patient and the assessor (who will not be the treating physician) will not know which procedural approach was used for the sides.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •Failure of conservative treatment, including nonsteroidal anti-inflammatory medications and physical therapy
- •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
- •Radicular pain below the knee
- •Systemic infection or localized infection at the anticipated introducer entry site
- •Allergy to Lidocaine
- •Bleeding dyscrasias
- •Patients unable to give informed consent
- •History of lumbar spine surgery at the affected levels
- •History of previous bilateral lumbar RFA of medial branches within the past six months.
- •Significant comorbid somatization or widespread pain with central sensitization
- •Secondary gain identified due to ongoing legal proceedings or worker's compensation
- •Cognitive impairment
- •Any pre-existing condition at the discretion of the provider that may confound interpretation of results -
Arms & Interventions
Subjects with traditional approach on the right side and parasagittal approach on the left side.
Patients will undergo bilateral RFA; the right side will be done following the traditional approach, and the left side will be done following the parasagittal approach. Traditional approach is done by placing the electrode at a 20 degrees' ipsilateral oblique angle to the sagittal plane toward the junction of the superior articular process and transverse process of the vertebral body to target the traversing medial branch nerve. The reason for the proposed angle is to avoid the mamillo-accessory ligament that may be ossified in up to 10% of the normal spine and potentially prevent proper coagulation of the medial branch nerve during the RFA procedure. Parasagittal (new) approach: is performed by placing the RF cannula parasagittally and more dorsally. 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.
Intervention: Radiofrequency ablation of lumbar medial branch nerves. (Procedure)
Subjects with traditional approach on the left side and parasagittal approach on the right side.
Patients will undergo bilateral RFA; the left side will be done following the traditional approach, and the right side will be done following the parasagittal approach. Traditional approach is done by placing the electrode at a 20 degrees' ipsilateral oblique angle to the sagittal plane toward the junction of the superior articular process and transverse process of the vertebral body to target the traversing medial branch nerve. The reason for the proposed angle is to avoid the mamillo-accessory ligament that may be ossified in up to 10% of the normal spine and potentially prevent proper coagulation of the medial branch nerve during the RFA procedure. Parasagittal (new) approach: is performed by placing the RF cannula parasagittally and more dorsally. 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.
Intervention: Radiofrequency ablation of lumbar medial branch nerves. (Procedure)
Outcomes
Primary Outcomes
The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores).
Time Frame: Baseline
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).
Time Frame: 1 month post-procedure.
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).
Time Frame: 6 months post-procedure.
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)(Baseline)
- Oswestry Disability index (ODI)(1 month post-procedure.)
- Oswestry Disability index (ODI)(6 months post-procedure.)
Investigators
Bunty Shah
Associate Professor, Department of Anesthesiology and Perioperative Medicine
Milton S. Hershey Medical Center