A Trial of Cooled Radiofrequency Ablation of Medial Branch Nerves for theTreatment of Lumbar Facet Syndrome

NCT ID: NCT02478437

Last Updated: 2018-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2018-08-31

Brief Summary

This study is being done to determine whether cooled radiofrequency ablation (CRFA) on the medial branch nerves of the lumbar facet joint is effective for the treatment of low back pain. CRFA blocks the nerves that carry pain signals from joints in the lower back such that the brain does not receive the message that the low back is in pain. This technique is commonly performed by burning these nerves rather freezing them, but it is suspected that freezing them results in better pain relief. The CRFA blocks has been shown to effectively treat sacroiliac joint pain (a joint in the pelvis), which is another reason that it is suspected that CRFA will be effective when treating pain related to facet joints in the low back. We are performing this study in order to determine if that is the case.

Detailed Description

The CRFA blocks has been shown to effectively treat sacroiliac joint pain (a joint in the pelvis), which is another reason that it is suspected that CRFA will be effective when treating pain related to facet joints in the low back. We are performing this study in order to determine if that is the case.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 1

Conventional radiofrequency ablation (RFA) Following ablation, 0.5 cc of 0.5% bupivacaine will be injected to provide post procedure analgesia.

Group Type: ACTIVE_COMPARATOR

Conventional radiofrequency ablation (RFA)

Intervention Type: PROCEDURE

A conventional RFA electrode with a 10mm active tip will be used. RFA lesions will be performed for 90 seconds with the maximum electrode temperature raised to 80°C.

Group 2

Cooled radiofrequency ablation (CRFA) Following ablation, 0.5 cc of 0.5% bupivacaine will be injected to provide post procedure analgesia.

Group Type: ACTIVE_COMPARATOR

Cooled Radiofrequency Ablation (CRFA)

Intervention Type: PROCEDURE

Following 18G C-RFA electrode positioning, 1cc of 2% lidocaine will be injected through the introducer needle for anesthesia during the ablation. The maximum electrode temperature is 60°C.

Interventions

Conventional radiofrequency ablation (RFA)

A conventional RFA electrode with a 10mm active tip will be used. RFA lesions will be performed for 90 seconds with the maximum electrode temperature raised to 80°C.

Intervention Type: PROCEDURE

Cooled Radiofrequency Ablation (CRFA)

Following 18G C-RFA electrode positioning, 1cc of 2% lidocaine will be injected through the introducer needle for anesthesia during the ablation. The maximum electrode temperature is 60°C.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with lumbar facet syndrome pain who would undergo treatment by lumbar medial branch radiofrequency ablation.
• Low back pain for at least 6 months.
• Pain resistant to conventional therapy including NSAIDs, opioids, muscle relaxants, oral steroids, physical therapy or chiropractic care.
• Pain diagram suggesting possibility of facet-mediated pain.
• Referred pain when present not beyond the knee.
• Positive response to at least 1 set of diagnostic intra-articular facet injections or medial branch blocks, defined as > 75% reduction in pain following diagnostic blocks with local anesthetic (0.5mL of 0.5% bupivacaine OR 0.5 mL of 2% lidocaine).

Exclusion Criteria

• Focal neurologic signs or symptoms.
• Radiologic evidence of a symptomatic herniated disc or nerve root impingement related to spinal stenosis.
• Previous radiofrequency ablation treatment for similar symptoms.
• Patient refusal.
• Lack of consent.
• Active systemic or local infections at the site of proposed needle and electrode placement.
• Coagulopathy or other bleeding disorder, current use of anticoagulants or anti-platelet medications.
• Allergy to medications being used for injection procedures (contrast dye, local anesthetic, IV sedative).
• Inability to read English, communicate with staff, or participate in follow up.
• Pregnancy.
• Cognitive deficit.
• Negative response to diagnostic intra-articular facet injections or medial branch blocks, defined as < 75% reduction in pain following diagnostic blocks with local anesthetic (0.5mL of 0.5% bupivacaine OR 0.5 mL of 2% lidocaine).
• Daily opiate analgesic use more exceeding 3 months prior to study inclusion.
• Unstable medical or psychiatric illness.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Pain Society

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

David Walega

Associate Professor, Chief, Division of Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Walega, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University Feinberg School of Medicine

Locations

Anesthesiology Pain Managment Center

Chicago, Illinois, United States

Countries

United States

References

McCormick ZL, Choi H, Reddy R, Syed RH, Bhave M, Kendall MC, Khan D, Nagpal G, Teramoto M, Walega DR. Randomized prospective trial of cooled versus traditional radiofrequency ablation of the medial branch nerves for the treatment of lumbar facet joint pain. Reg Anesth Pain Med. 2019 Mar;44(3):389-397. doi: 10.1136/rapm-2018-000035.

Reference Type: DERIVED

PMID: 30777903 (View on PubMed)

Other Identifiers

STU00097239

Identifier Type: -

Identifier Source: org_study_id