A Trial of Cooled Radiofrequency Ablation of Medial Branch Nerves for theTreatment of Lumbar Facet Syndrome (STU00097239)

Northwestern University

Status and phase

Completed

Phase 3

Conditions

Low Back Pain

Treatments

Procedure: Cooled Radiofrequency Ablation (CRFA)

Procedure: Conventional radiofrequency ablation (RFA)

Study type

Interventional

Funder types

Other

Identifiers

NCT02478437

STU00097239

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 patients

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

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.