Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness of Cervical Transforaminal Epidural Steroid Injection

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04544683
Recruitment Status : Recruiting
First Posted : September 10, 2020
Last Update Posted : September 10, 2020
Sponsor:
Information provided by (Responsible Party):
Zack McCormick, University of Utah

Brief Summary:

Study Purpose:

This study is intended to monitor outcomes for 1 year following cervical TFESI. Based on current clinic volume and enrollment rates into a current study of cervical epidural injections that is nearing completion, we conservatively estimate a study enrollment period of 18 months and a total period of 2.5 years from enrollment to final follow-up data collection. If the study were to theoretically start enrolling in July 2019, we would anticipate completion by February 2022.

Objectives:

  1. Determine the proportion of patients with an 80% or greater improvement in arm and neck numerical rating scale pain (NRS) score following an initial cervical transforaminal steroid injection (TFESI) at 4 weeks post-injection and the duration of response up to 12 months.
  2. Determine the proportion of patients with a 50%-79% improvement in arm and neck NRS score following an initial cervical TFESI at 4 weeks post-injection and the duration of response up to 12 months.
  3. Determine the proportion of patients with less than 50% improvement in arm and neck NRS score following an initial cervical TFESI at 4 weeks post-injection and the duration of response up to 12 months.
  4. Determine the proportion of patients with an initial injection plus up to 3 additional injections that maintain 80% or greater, as well as 50-79%, improvement in arm and neck NRS score for up to 12 months.
  5. Determine the proportion of patients with a clinically significant change in function defined by a minimally clinically significant change (MCIC) (≥10 point improvement ) or 30% improvement in Neck Disability Index (NDI) score following an initial cervical TFESI at 4 weeks post-injection and the duration of response up to 12 months.
  6. Determine the proportion of patients with clinically significant improvement in the Medication Quantification Scale (MQS III) score (≥6.8 point change , equivalent to 10 oral morphine equivalents ) following an initial cervical TFESI at 4 weeks post-injection and the duration of response up to 12 months.

6. Determine the proportion of patients with clinically significant improvement in the categorical EuroQol 5 Dimensions tool (EQ-5D) defined by ≥0.03 following an initial cervical TFESI at 4 weeks post-injection and the duration of response up to 12 months.

7. Compare patient demographic, clinical, and imaging characteristics between response groups and perform predictive modeling to better understand variables that increase the likelihood of a successful clinical outcome.

8. Report adverse effects.


Condition or disease Intervention/treatment Phase
Cervical Radiculopathy Cervical Spondylosis Disk, Herniated Drug: Cervical Transforaminal Epidural Injection with dexamethasone sodium phosphate Phase 4

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 117 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Through a research questionnaire, pre-procedure and post procedure NRS pain score for both neck and arm we will obtain data regarding cervical epidural steroid injections via a transforaminal approach for research purposes only. Also current pain medications of patient throughout treatment will be obtained for research purposes.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effectiveness of Cervical Transforaminal Epidural Steroid Injection for the Treatment of Cervical Radicular Pain: A Prospective Cohort Study.
Actual Study Start Date : October 23, 2018
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : July 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Cervical Pain for 6 months or less and scheduled for TFESI
Participants who meet inclusion and exclusion criteria will be enrolled into the study after consenting to and before receiving a first cervical TFESI. The baseline examination and all baseline questionnaires will be completed within 2 weeks before the first cervical TFESI. Participants will be given a daily pain diary chart to record NRS and percentage improvement during the 1st month post-injection. Participants will be contacted in the 1st week post-injection with a standardized questionnaire about their symptoms and a reminder about the 4 week (+/- 1 week) post-injection follow up. Routine scheduled follow-up by clinic visit or telephone call will occur at 4 weeks (+/- 1 week), 8 weeks (+/- 2 weeks), 3 months (+/- 2 weeks), 6 months (+/- 1 month), and 12 months (+/- 1 month), at which times all follow-up measures will be obtained.
Drug: Cervical Transforaminal Epidural Injection with dexamethasone sodium phosphate
Transforaminal epidural steroid injection: Injection of 1 to 2 mL of 1% lidocaine to the skin and subcutaneous tissues, a 25-gauge spinal needle will be placed at the level and side of radicular pathology, based on clinical correlation of symptoms/signs and magnetic resonance imaging findings. Advancement to the appropriate target position in the neuroforamen will be performed under fluoroscopic guidance. Satisfactory target position achieved and confirmed in both anterior-posterior and oblique views, 0.5 to 1 mL of contrast will be injected under live fluoroscopic observation with or without digital subtraction angiography depending on suggestion of vascular uptake. Upon confirmation of a satisfactory epidural contrast pattern without vascular uptake, the injectate will be delivered: dexamethasone sodium phosphate 1mL (10mg/mL) and 0.5 ml of 1% preservative-free lidocaine (total volume 1.5 mL).




Primary Outcome Measures :
  1. 80% or greater improvement in index pain [ Time Frame: 4 weeks, 3 months, 12 months ]
    80% or greater improvement in index pain following an initial cervical transforaminal injection of steroid (TFESI) at 4 weeks post-injection, 3 months post-injection and response at 12 months.

  2. 50-79% improvement in index pain [ Time Frame: 4 weeks, 3 months, 12 months ]
    50%-79% improvement in index pain following an initial cervical TFESI at 4 weeks post-injection, 3 months post-injection, and response 12 months.

  3. 50% or less improvement in index pain [ Time Frame: 4 weeks, 3 months, 12 months ]
    Less than 50% improvement in index pain following an initial cervical TFESI at 4 weeks post-injection, 3 months post-injection, and response at 12 months.



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 to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients aged 18-80 capable of understanding and providing consent in English and capable of complying with the outcome instruments used.
  • Arm pain or shoulder girdle pain/periscapular pain with or without neck pain with duration less than or equal to 6 months.
  • 3-day average numeric pain rating score (NRS) for arm pain or shoulder girdle/periscapular pain of at least 4/10 at baseline evaluation, with neck pain score not exceeding arm and/or shoulder girdle/periscapular pain score.
  • MRI (or CT if MRI not available) shows either a one level cervical disc herniation, disc osteophyte complex or degenerative foraminal stenosis, corresponding in side and location with predominately unilateral radicular pain, with or without neurological deficits. MRI may show degenerative changes at other levels.
  • Patient consents to treatment with epidural injection in a shared decision-making process with the treating physician.
  • Pain duration of at least 6 weeks or more.

Exclusion Criteria:

  • Those receiving remuneration for their pain treatment (e.g., disability, worker's compensation).
  • Those involved in active litigation relevant to their pain.
  • The patient is incarcerated.
  • Neck pain is greater than arm pain or shoulder girdle/periscapular pain.
  • Bilateral radicular signs/symptoms (< 90% laterality of pain intensity, or bilateral neurological signs).
  • BMI>35.
  • Prior epidural steroid injections for treatment of current episode.
  • Those unable to read English and complete the assessment instruments.
  • Spondylolisthesis at the involved or adjacent segments.
  • Systemic inflammatory arthritis (e.g., rheumatoid, lupus).
  • Addictive behavior, severe clinical depression, or psychotic features.
  • Possible pregnancy or other reason that precludes the use of fluoroscopy.
  • Treatment of infection with antibiotics within the past 7 days.
  • Progressive motor deficit and/or clinical signs of myelopathy.
  • History of prior cervical spine surgery.
  • Medical conditions causing significant functional disability (e.g., stroke, COPD)

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): NCT04544683


Contacts
Layout table for location contacts
Contact: Shellie Cunningham, BS 801-587-5488 shellie.cunningham@hsc.utah.edu
Contact: Aaron Conger, MD 801-587-5488 aaron.conger@hsc.utah.edu

Locations
Layout table for location information
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Shellie Cunningham, BS    801-587-5488    shellie.cunningham@hsc.utah.edu   
Contact: Aaron Conger, MD    801-587-5488    aaron.conger@hsc.utah.edu   
Sponsors and Collaborators
University of Utah
Layout table for additonal information
Responsible Party: Zack McCormick, Zachary McCormick, MD FAAPMR, Associate Professor, Director of Clinical Spine Research, Director of Interventional Spine and Musculoskeletal Medicine Fellowship, University of Utah
ClinicalTrials.gov Identifier: NCT04544683    
Other Study ID Numbers: IRB 116040
First Posted: September 10, 2020    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Zack McCormick, University of Utah:
Transforaminal Epidural Injection
Additional relevant MeSH terms:
Layout table for MeSH terms
Spondylosis
Intervertebral Disc Displacement
Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Hernia
Pathological Conditions, Anatomical
Dexamethasone
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action