Medial Branch Blocks vs. Intra-articular Injections: Randomized, Controlled Study

Completed · Not applicable

Conditions studied: Lumbar Facet Joint Pain, Low Back Pain

In brief

Background: Facet interventions are the second most commonly performed procedure in pain clinics throughout the U.S, including in the military. Currently, there is no clear consensus regarding whether intra-articular (IA) blocks or medial branch blocks (facet joint nerve; MBB) are the best way to diagnose and treat facetogenic pain, or even whether or not to perform diagnostic/ prognostic blocks. Hypothesis: IA blocks will provide better relief than MBB, but MBB may better select patients for radiofrequency denervation. Purpose: Objective 1: Determine which "prognostic" block is the best predictor for RF denervation outcome; Objective 2: To determine whether adding steroids to IA or MBB may provide intermediate or long-term benefit to a subset of individuals. Research Design: Randomized, comparative-effectiveness study Methodology /Technical Approach: A total of 225 patients with non-radicular chronic low back pain (LBP) with suspected facetogenic etiology will be randomized in a 2:2:1 ratio to one of 3 groups: Group 1 will receive IA blocks with steroids and LA Group 2 will receive MBB with steroids and LA Group 3 will receive MBB with only saline Those individuals who obtain significant (≥ 50% in groups 1 and 2,3) but temporary (\< 1-month) relief will undergo radiofrequency (RF) denervation at their 1-month follow-up. In group 3, those patients who do not experience pain relief at 1-month will undergo RF denervation regardless of the pain relief they experience (as many practitioners in the military and civilian practices do without diagnostic blocks).1-3 Participants in Groups 1 and 2 who experience prolonged relief from their diagnostic/ therapeutic blocks with LA and steroids will not undergo RF denervation until their pain returns. Those individuals who experience prolonged relief lasting \> 6 months will be given the option of repeating the diagnostic/ therapeutic block. In Groups 1, 2 and 3 patients who experience prolonged relief from the diagnostic blocks, follow-up visits will be at 1-month, 3-months and 6-months after the block, or until their pain relief wears off. In those who undergo denervation based on a positive block, follow-ups will be performed 1, 3 and 6-months after the denervation provided they continue to experience significant (\> 50%) relief at each follow-up. Those individuals who fail to experience significant relief after denervation will be unblinded and exit the study per protocol.

Key facts

Study ID

NCT02002429

Run by

Johns Hopkins University

People needed

225

Starts

2014-03-01

Expected to finish

2017-08-01

Last updated by the study team

2018-01-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 18 years
• Suspected lumbar facet arthropathy based on history and physical exam (e.g. axial lower back pain, paraspinal tenderness, no pain referral below the knee)
• NRS back pain score > 4;
• MRI evidence of spinal pathology consistent with symptoms.

You may not qualify if…

• Untreated coagulopathy
• No MRI study
• Signs or symptoms of cauda equina syndrome
• Focal neurological signs and symptoms
• Allergic reactions to local anesthetics or contrast dye
• Serious medical or condition that might preclude optimal outcome
• Pregnancy

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Walter Reed National Military Medical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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