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

NCT02478437 | Completed Phase 3

• 1 other identifier: STU00097239
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Lumbar Facet Syndrome

Outcome Measures

Primary Outcomes (1)

• Pain improvement

  Percent of participants who reported 50% or greater improvement in pain

  6 months post-procedure

Secondary Outcomes (4)

• Global pain score

  1 month, 3 months, 6 months and 12 months post procedure

• McGill Pain Questionnaire (MPQ)

  1 month, 3 months, 6 months and 12 months post procedure

• Pain Anxiety Symptom Scale short form (PASS-20)

  1 month, 3 months, 6 months and 12 months post procedure

• Center for Epidemiologic Studies Depression short form index (CESD-10)

  1 month, 3 months, 6 months and 12 months post procedure

Study Arms (2)

Group 1

ACTIVE COMPARATOR

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

Procedure: Conventional radiofrequency ablation (RFA)

Group 2

ACTIVE COMPARATOR

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

Procedure: Cooled Radiofrequency Ablation (CRFA)

Interventions

Conventional radiofrequency ablation (RFA) 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 1

Cooled Radiofrequency Ablation (CRFA) 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.

Group 2

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).
• Unstable medical or psychiatric illness.

Sponsors & Collaborators

• Northwestern University: lead
• American Pain Society: collaborator

Study Sites (1)

Anesthesiology Pain Managment Center

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• 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.

  PMID: 30777903 DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Walega, MD

  Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Chief, Division of Pain Medicine

Study Record Dates

• First Submitted: June 17, 2015
• First Posted: June 23, 2015
• Study Start: June 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: September 6, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)