Clinical trial NCT02478437: A Trial of Cooled Radiofrequency Ablation of Medial Branch Nerves for theTreatment of Lumbar Facet Syndrome
Official title: A Prospective Trial of Cooled Radiofrequency Ablation of Medial Branch Nerves for the Treatment of Lumbar Facet Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Low Back Pain
Keywords: Lumbar Facet Syndrome
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: American Pain Society
First posted: 2015-06-23
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain improvement
timeFrame: 6 months post-procedure
Secondary outcomes:
measure: Global pain score
timeFrame: 1 month, 3 months, 6 months and 12 months post procedure
measure: McGill Pain Questionnaire (MPQ)
timeFrame: 1 month, 3 months, 6 months and 12 months post procedure
measure: Pain Anxiety Symptom Scale short form (PASS-20)
timeFrame: 1 month, 3 months, 6 months and 12 months post procedure
measure: Center for Epidemiologic Studies Depression short form index (CESD-10)
timeFrame: 1 month, 3 months, 6 months and 12 months post procedure
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Anesthesiology Pain Managment Center
state: Illinois
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: David Walega, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.