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

Low Back Pain Clinical Trial

— STU00097239  

Official title:

A Prospective Trial of Cooled Radiofrequency Ablation of Medial Branch Nerves for the Treatment of Lumbar Facet Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02478437
• Other study ID #: STU00097239
• Status: Completed
• Phase: Phase 3
• Start date: June 2015
• Est. completion date: August 2018

Study information

• Verified date: September 2018
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Anesthesiology Pain Managment Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	American Pain Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain improvement	Percent of participants who reported 50% or greater improvement in pain	6 months post-procedure
Secondary	Global pain score	Global Numeric Rating Scale (NRS, 0 is no pain and 10 is worst pain imaginable)	1 month, 3 months, 6 months and 12 months post procedure
Secondary	McGill Pain Questionnaire (MPQ)	Scores are tabulated by summing values associated with each word; scores range from 0 (no pain) to 78 (severe pain).	1 month, 3 months, 6 months and 12 months post procedure
Secondary	Pain Anxiety Symptom Scale short form (PASS-20)	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).	1 month, 3 months, 6 months and 12 months post procedure
Secondary	Center for Epidemiologic Studies Depression short form index (CESD-10)	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.	1 month, 3 months, 6 months and 12 months post procedure