Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02002429
Recruitment Status : Completed
First Posted : December 5, 2013
Last Update Posted : January 12, 2018
Sponsor:
Collaborators:
Uniformed Services University of the Health Sciences
Walter Reed National Military Medical Center
Information provided by (Responsible Party):
Johns Hopkins University

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.


Condition or disease Intervention/treatment Phase
Lumbar Facet Joint Pain Low Back Pain Procedure: Intra-articular injection Procedure: Medial branch block Procedure: Saline injection Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Medial Branch Blocks vs. Intra-articular Injections: Randomized, Controlled Study Comparing Lumbar Facet Radiofrequency Denervation Using Diagnostic Injections.
Actual Study Start Date : March 2014
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Arm Intervention/treatment
Experimental: Intra-articular injection
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
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.

Active Comparator: Medial branch block
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
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.

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




Primary Outcome Measures :
  1. Pain Score [ Time Frame: 1 month ]
    0-10 numerical rating scale (NRS) average pain score after facet injection

  2. Pain Score [ Time Frame: 3 months ]
    0-10 numerical rating scale pain score after radiofrequency ablation


Secondary Outcome Measures :
  1. Successful outcome after RF denervation [ Time Frame: 1 month ]
    Proportion of patients in each arm who undergo RF denervation who experience a > 50% decrease in pain score and a satisfaction score > 3

  2. Successful outcome after RF denervation [ Time Frame: 3 months ]
    Proportion of patients in each arm who undergo RF denervation who experience a > 50% decrease in pain score and a satisfaction score > 3

  3. Successful outcome after RF denervation [ Time Frame: 6 months ]
    Proportion of patients in each arm who undergo RF denervation who experience a > 50% decrease in pain score and a satisfaction score > 3

  4. Successful outcome after facet block [ Time Frame: 1 month ]
    Proportion of patients in each arm who undergo RF denervation who experience a > 50% decrease in pain score and a satisfaction score > 3

  5. Successful outcome after facet block [ Time Frame: 3 months ]
    Proportion of patients in each arm who undergo RF denervation who experience a > 50% decrease in pain score and a satisfaction score > 3

  6. Successful outcome after facet block [ Time Frame: 6 months ]
    Proportion of patients in each arm who undergo RF denervation who experience a > 50% decrease in pain score and a satisfaction score > 3

  7. Proportion of people with a positive pain diary [ Time Frame: 1-day after injection ]
    Proportion of people who experience > 50% pain relief after the diagnostic block

  8. Pain score [ Time Frame: 1 month ]
    Worst NRS pain score 1 month after initial injection

  9. Pain score [ Time Frame: 3 months ]
    Average NRS pain score 3 months after initial injection

  10. Pain score [ Time Frame: 3 months ]
    Worst NRS pain score 3 months after initial injection

  11. Pain score [ Time Frame: 6 months ]
    Average NRS pain score 6 months after initial injection

  12. Pain score [ Time Frame: 6 months ]
    Worst NRS pain score 6 months after initial injection

  13. Pain score [ Time Frame: 1 month ]
    Average NRS pain score 1 month after RF denervation

  14. Pain score [ Time Frame: 1 month ]
    Worst NRS pain score 1 month after RF denervation

  15. Pain score [ Time Frame: 3 months ]
    Worst NRS pain score 3 months after RF denervation

  16. Pain score [ Time Frame: 6 months ]
    Average NRS pain score 6 months after RF denervation

  17. Pain score [ Time Frame: 6 months ]
    Worst NRS pain score 6 months after RF denervation

  18. Function [ Time Frame: 1 month ]
    Oswestry disability index score 1-month after initial injection

  19. Function [ Time Frame: 3 months ]
    Oswestry disability score 3-months after initial injection

  20. Function [ Time Frame: 3 months ]
    Oswestry disability score 6-months after initial injection

  21. Function [ Time Frame: 1 month ]
    Oswestry disability score 1-month after RF denervation

  22. Function [ Time Frame: 3 months ]
    Oswestry disability score 3-months after RF denervation

  23. Function [ Time Frame: 6 months ]
    Oswestry disability score 6-months after RF denervation

  24. Satisfaction [ Time Frame: 1-month ]
    Satisfaction on 1-5 scale 1-month after initial injection

  25. Satisfaction [ Time Frame: 3-months ]
    Satisfaction on 1-5 scale 3-months after initial injection

  26. Satisfaction [ Time Frame: 6-months ]
    Satisfaction on 1-5 scale 6-months after initial injection

  27. Satisfaction [ Time Frame: 1-month ]
    Satisfaction on 1-5 scale 1-month after RF denervation

  28. Satisfaction [ Time Frame: 3-months ]
    Satisfaction on 1-5 scale 3-months after RF denervation

  29. Satisfaction [ Time Frame: 6-months ]
    Satisfaction on 1-5 scale 6-months after RF denervation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02002429


Locations
Layout table for location information
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
Sponsors and Collaborators
Johns Hopkins University
Uniformed Services University of the Health Sciences
Walter Reed National Military Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Steven P Cohen, MD Johns Hopkins University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02002429     History of Changes
Other Study ID Numbers: NA_00086597
First Posted: December 5, 2013    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Johns Hopkins University:
Facet joint
Medial branch block
Radiofrequency denervation
Zygapophysial joint
Low back pain

Additional relevant MeSH terms:
Layout table for MeSH terms
Back Pain
Low Back Pain
Arthralgia
Pain
Neurologic Manifestations
Signs and Symptoms
Joint Diseases
Musculoskeletal Diseases
Pharmaceutical Solutions
Bupivacaine
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists