Lumbar Spondylosis
Conditions
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.
Interventions
PROCEDURERadiofrequency ablation of lumbar medial branch nerves.
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. Parasagittal (new) approach: The RF cannula is placed parasagittally and more dorsally. The remainder of the procedure does not differ from the traditional method.
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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.
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,
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability index (ODI) | Baseline | 10 questions assessing the functional impairment by the pain, using a 50 point scale, with 0 meaning no disability, and 50 meaning complete disability. |
Countries
United States
Contacts
CONTACTNancy Ruth Jarbadan, BS
PRINCIPAL_INVESTIGATORYakov Vorobeychik, MD PhD
Professor, Department of Anesthesiology
Outcome results
None listed