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

Phase 3

Completed

• Conditions: Low Back Pain
• Interventions: Procedure: Cooled Radiofrequency Ablation (CRFA); Procedure: Conventional radiofrequency ablation (RFA)

• Registration Number: NCT02478437
• Lead Sponsor: Northwestern University

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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-17
• Study First Submitted QC: 2015-06-18
• Study First Posted: 2015-06-23
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-05
• Last Update Posted: 2018-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 2	Cooled Radiofrequency Ablation (CRFA)	Cooled radiofrequency ablation (CRFA) Following ablation, 0.5 cc of 0.5% bupivacaine will be injected to provide post procedure analgesia.
Group 1	Conventional radiofrequency ablation (RFA)	Conventional radiofrequency ablation (RFA) Following ablation, 0.5 cc of 0.5% bupivacaine will be injected to provide post procedure analgesia.

Primary Outcome Measures

Name	Time	Method
Pain improvement	6 months post-procedure	Percent of participants who reported 50% or greater improvement in pain

Secondary Outcome Measures

Name	Time	Method
Global pain score	1 month, 3 months, 6 months and 12 months post procedure	Global Numeric Rating Scale (NRS, 0 is no pain and 10 is worst pain imaginable)
Center for Epidemiologic Studies Depression short form index (CESD-10)	1 month, 3 months, 6 months and 12 months post procedure	The possible range of the 10-item scale is 0 to 30, and a cut off score of ten or higher indicates the presence of significant depressive symptoms. Subjects responded to each item of the scale by rating the frequency of each mood or symptom ''during the past week'' on a four-point scale.
McGill Pain Questionnaire (MPQ)	1 month, 3 months, 6 months and 12 months post procedure	Scores are tabulated by summing values associated with each word; scores range from 0 (no pain) to 78 (severe pain).
Pain Anxiety Symptom Scale short form (PASS-20)	1 month, 3 months, 6 months and 12 months post procedure	The PASS-20 assesses 4 factorially distinct components of pain-related anxiety. Each question is in a form of a 6-point Likert Scale anchored from 0 (never) to 5 (always).

Trial Locations

Locations (1)

Anesthesiology Pain Managment Center; 🇺🇸 Chicago, Illinois, United States