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Trial record 8 of 119 for:    "Neuromuscular Disease" | "Lidocaine"

Comparative Trial Via Tranforaminal Approach Versus Epidural Catheter Via Interlaminar Approach

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ClinicalTrials.gov Identifier: NCT03382821
Recruitment Status : Recruiting
First Posted : December 26, 2017
Last Update Posted : October 12, 2018
Sponsor:
Collaborator:
Epimed
Information provided by (Responsible Party):
University of Utah

Brief Summary:
Do cervical epidural steroid injections done by transforaminal catheter targeted approach improve pain and function in patients with cervical radicular pain?

Condition or disease Intervention/treatment Phase
Cervical Radiculopathy Procedure: Transforaminal ESI with dexamethasone Procedure: Transforaminal catheter-targeted ESI with triamcinolone Drug: Dexamethasone Sodium Phosphate 10 MG/ML Drug: Lidocaine Drug: Triamcinolone Acetonide 40mg/mL Phase 4

Detailed Description:

Two distinct techniques used to administer epidural steroids specifically to the nerve root affected in a radicular pain syndrome, which include transforaminal access at the level of pathology and interlaminar interlaminar access at the C7-T1 level with subsequent advancement of an epidural cathether to the level of pathology. Use of an epidural catheter is necessary in order to achieve a targeted injection via an interlaminar approach in order to prevent dural puncture or direct spinal cord trauma. Anatomic studies confirm the distance between the ligamentum flavum and dura is on average, 4 mm at the C7-T1 or C6-C7 levels, but 1mm or smaller at C5-C6 and more rostral levels. Therefore, there is likely greater risk of dural puncture and spinal cord injury when "targeting" steroid delivery using only the interlaminar technique directly at the level where pathology is located (C4-C5, or C5-C6, for example). Thus, the interlaminar placement of a needle rostral to the C6-C7 level has been strongly discouraged.

Both the transforaminal injection approach and the targeted catheter approach demonstrate effectiveness. Studies have demonstrated the effectiveness of transforaminal epidural steroid injection for the treatment of cervical radicular pain. Our own recent work demonstrates the clinical effectiveness of the catheter-based targeted approach. However, these two approaches have never been directly compared. Thus, we aim to compare the differences in pain reduction, medication utilization, functional outcomes, patient satisfaction, and surgical rate reduction between these two approaches to the treatment of cervical radicular pain.

Cervical radicular pain is a common syndrome, often treated with epidural steroid injection (ESI). An approach that targets the therapeutic agent, corticosteroid, at the site of spinal pathology can be performed via a transforaminal approach or via a interlaminar approach at C7-T1 with subsequent epidural catheter advancement to the symptomatic level. There are no universal guidelines that recommend the use of one technique over the other. We will directly compare the clinical effectiveness of these two approaches as measured by pain reduction, medication utilization, functional outcomes, patient satisfaction, and surgical rate reduction. The results of this study will potentially influence clinical practice recommendations regarding the treatment of cervical radicular pain. If one technique proves superior, instating this technique will have implications potentially for reducing opioid use, surgery and other healthcare utilization, and general healthcare cost related to the treatment of cervical radicular pain.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, comparative trial
Masking: Single (Participant)
Masking Description: Each subject will be randomized into a group assignment in a 1:1 manner, #1 or #2, as outlined in the Methods section
Primary Purpose: Treatment
Official Title: A Prospective Randomized Comparative Trial of Targeted Injection Via a Transforaminal Approach With Dexamethasone Versus an Epidural Catheter Via an Interlaminar Approach With Particulate Steroid for the Treatment of Cervical Radicular Pain
Actual Study Start Date : January 3, 2018
Estimated Primary Completion Date : January 15, 2020
Estimated Study Completion Date : January 14, 2021


Arm Intervention/treatment
Active Comparator: Transforaminal ESI with dexamethasone
Group 1: Transforaminal cervical ESI with dexamethasone sodium phosphate
Procedure: Transforaminal ESI with dexamethasone
Catheter-targeted ESI via interlaminar access at the C7-T1 level with dexamethasone sodium phosphate 1.5 mL (10 mg/mL) and 1 ml 1% lidocaine (total volume 2.5 mL).

Drug: Dexamethasone Sodium Phosphate 10 MG/ML
Transforaminal ESI with dexamethasone 1.5 mL of dexamethasone sodium phosphate in group #1

Drug: Lidocaine
1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2
Other Name: Xylocaine

Active Comparator: Transforaminal catheter-targeted ESI with triamcinolone
Group 2: Catheter-targeted cervical ESI with triamcinolone acetonide
Procedure: Transforaminal catheter-targeted ESI with triamcinolone
Catheter-targeted ESI via interlaminar access at the C7-T1 level with triamcinolone acetonide 2 mL (40mg/mL) and 1 ml 1% lidocaine (total volume 3 mL).

Drug: Lidocaine
1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2
Other Name: Xylocaine

Drug: Triamcinolone Acetonide 40mg/mL
Transforaminal catheter-targeted ESI with triamcinolone acetonide 2 mL in group #2
Other Name: Kenalog




Primary Outcome Measures :
  1. Pain Reduction Amount for Neck and Arm [ Time Frame: 1 month follow up ]
    Pain Reduction, measured with Numerical Rating Scale (0-10, 0 being no pain and 10 being worst pain imaginable), 50 percent or greater reduction for both neck and arm(s)


Secondary Outcome Measures :
  1. Numerical Rating Scale Median [ Time Frame: 2 week, 1 month, 3 month, 6 month, and 1 year follow up ]
    Reduction in median Numerical Rating Scale (0-10, 0 being no pain and 10 being worst pain imaginable) pain score for both neck pain and arm pain

  2. Neck Disability Index-5 [ Time Frame: 2 week, 1 month, 3 month, 6 month, and 1 year follow up ]
    5 questions that make up the neck disability index (NDI-5).

  3. Current pain medication [ Time Frame: 2 week, 1 month, 3 month, 6 month, and 1 year follow up ]
    Pain medication changes throughout treatment using Medication Quantification Scale III calculator

  4. Patient Global Impression of Change [ Time Frame: 2 week, 1 month, 3 month, 6 month, and 1 year follow up ]
    Seven point question called Patient Global Impression of Change

  5. Responder analysis [ Time Frame: 1 year ]
    Include the proportion of patients with 30 percent or greater improvement on the Neck Disability Index-5, a Patient Global Impression of Change scale score less than 3 (indicating "improved" or "very much improved"), a 6.8 or greater point reduction on the Medication Quantification Scale III score (equivalent to approximately 10 daily morphine equivalents),and the proportion of participants who undergo surgical spine surgery.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-80.
  • Clinical diagnosis of unilateral C4-C8 radicular pain.
  • Magnetic resonance imaging pathology consistent with clinical symptoms/signs.
  • Numerical Rating Scale (NRS) pain score of 4 or higher.
  • Pain duration of more than 6 weeks despite trial of conservative therapy (medications, physical therapy, or chiropractic care).

Exclusion Criteria:

  • Refusal to participate, provide consent, or provide follow-up information for the 6-month duration of the study.
  • Contraindications to Cervical Epidural Steroid Iinjection (CESI) (active infection, bleeding disorders, current anticoagulant or antiplatelet medication use, allergy to medications used for Cervical epidural steroid injection (CESI), and pregnancy).
  • Cervical spinal cord lesions; cerebrovascular, demyelinating, or other neuro-muscular muscular disease.
  • Current glucocorticoid use or Epidural Steroid Injection (ESI) within past 6 months.
  • Prior cervical spine surgery.
  • Patient request for or requirement of conscious sedation for the injection procedure.

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): NCT03382821


Contacts
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Contact: Shellie S Cunningham, BS 801-587-5488 shellie.cunningham@hsc.utah.edu
Contact: Matthew J Brobeck, AS 801-587-5488 matthew.brobeck@hsc.utah.edu

Locations
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United States, Utah
University of Utah Orthopaedic Center Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Shellie S Cunningham, BS    801-587-5488    shellie.cunningham@hsc.utah.edu   
Sponsors and Collaborators
University of Utah
Epimed
Investigators
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Principal Investigator: Zachary L McCormick, MD University of Utah

Publications:

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Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT03382821     History of Changes
Other Study ID Numbers: 105766
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Utah:
cervical epidural steroid injection
transforaminal approach
epidural catheter targeted
interlaminar approach
cervical radicular pain
Additional relevant MeSH terms:
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Neuromuscular Diseases
Lidocaine
Radiculopathy
Peripheral Nervous System Diseases
Nervous System Diseases
Dexamethasone
Dexamethasone acetate
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Dexamethasone 21-phosphate
BB 1101
Triamcinolone diacetate
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
Anesthetics, Local
Anesthetics
Central Nervous System Depressants