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

NCT02002429 | Completed

• 1 other identifier: NA_00086597
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Lumbar Facet Joint Pain; Low Back Pain

Keywords

Facet joint; Medial branch block; Radiofrequency denervation; Zygapophysial joint; Low back pain

Outcome Measures

Primary Outcomes (2)

• Pain Score

  0-10 numerical rating scale (NRS) average pain score after facet injection

  1 month

• Pain Score

  0-10 numerical rating scale pain score after radiofrequency ablation

  3 months

Secondary Outcomes (29)

• Successful outcome after RF denervation

  1 month

• Successful outcome after RF denervation

  3 months

• Successful outcome after RF denervation

  6 months

• Successful outcome after facet block

  1 month

• Successful outcome after facet block

  3 months

Study Arms (3)

Intra-articular injection

EXPERIMENTAL

Intra-articular injection into the affected facet joint(s) with 0.5 ml of a 50:50 solution containing 10 mg of depo-methylprednisolone and 0.5% bupivacaine

Procedure: Intra-articular injection

Medial branch block

ACTIVE COMPARATOR

Medial branch blocks at the nerves that supply the affected facet joint(s) with 0.5 ml of a 50:50 solution containing 10 mg of depo-methylprednisolone and 0.5% bupivacaine

Procedure: Medial branch block

Saline injection

SHAM COMPARATOR

Injection into the affected facet joint(s) with 0.5 ml of normal saline

Procedure: Saline injection

Interventions

Intra-articular injection PROCEDURE

Intra-articular injection into the affected facet joint(s) with 0.5 ml of a 50:50 solution containing 10 mg of depo-methylprednisolone and 0.5% bupivacaine. If the subject has a positive block a radiofrequency denervation will be performed at the affected joint.

Intra-articular injection

Medial branch block PROCEDURE

Medial branch blocks at the nerves that supply the affected facet joint(s) with 0.5 ml of a 50:50 solution containing 10 mg of depo-methylprednisolone and 0.5% bupivacaine. If the subject has a positive block a radiofrequency denervation will be performed at the affected joint.

Medial branch block

Saline injection PROCEDURE

Injection into the affected facet joint(s) with 0.5 ml of normal saline. All subjects in the group will receive radiofrequency denervation.

Saline injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Uniformed Services University of the Health Sciences: collaborator
• Walter Reed National Military Medical Center: collaborator

Study Sites (2)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Related Publications (3)

• Cohen SP, Huang JH, Brummett C. Facet joint pain--advances in patient selection and treatment. Nat Rev Rheumatol. 2013 Feb;9(2):101-16. doi: 10.1038/nrrheum.2012.198. Epub 2012 Nov 20.

  PMID: 23165358 BACKGROUND

• Cohen SP, Raja SN. Pathogenesis, diagnosis, and treatment of lumbar zygapophysial (facet) joint pain. Anesthesiology. 2007 Mar;106(3):591-614. doi: 10.1097/00000542-200703000-00024.

  PMID: 17325518 BACKGROUND

• Cohen SP, Doshi TL, Constantinescu OC, Zhao Z, Kurihara C, Larkin TM, Griffith SR, Jacobs MB, Kroski WJ, Dawson TC, Fowler IM, White RL, Verdun AJ, Jamison DE, Anderson-White M, Shank SE, Pasquina PF. Effectiveness of Lumbar Facet Joint Blocks and Predictive Value before Radiofrequency Denervation: The Facet Treatment Study (FACTS), a Randomized, Controlled Clinical Trial. Anesthesiology. 2018 Sep;129(3):517-535. doi: 10.1097/ALN.0000000000002274.

  PMID: 29847426 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Injections, Intra-Articular; Sodium Chloride

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Steven P Cohen, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2013
• First Posted: December 5, 2013
• Study Start: March 1, 2014
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: January 12, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)