Comparative Effectiveness of Two Different Approaches to Radiofrequency Ablation of Lumbar Medial Branch Nerves

Lumbar Spondylosis Clinical Trial

— LMB-RFA  

Official title:

Comparative Effectiveness of Two Different Approaches to Radiofrequency Ablation of Lumbar Medial Branch Nerves

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06283628
• Other study ID #: STUDY00023737
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Milton S. Hershey Medical Center
• Contact: Nancy Ruth Jarbadan, BS
• Phone: 717-531-6135
• Email: njarbadan[@]pennstatehealth.psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Lumbar Spondylosis
• Spondylosis

Intervention

Procedure:
• Radiofrequency 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.

Locations

Country	Name	City	State
United States	Penn State Hershey College of Medicine	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of subjects who ceased requiring analgesia	The patients will self-report their analgesic consumption.	Baseline
Other	Number of subjects who ceased requiring analgesia	The patients will self-report their analgesic consumption.	1 month post-procedure
Other	Number of subjects who ceased requiring analgesia	The patients will self-report their analgesic consumption.	6 months post-procedure
Primary	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.	Baseline
Primary	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.	1 month post-procedure.
Primary	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.	6 months post-procedure.
Secondary	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.	Baseline
Secondary	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.	1 month post-procedure.
Secondary	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.	6 months post-procedure.