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Transforaminal Versus Lateralized Interlaminar Cervical Epidurals

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ClinicalTrials.gov Identifier: NCT03389620
Recruitment Status : Not yet recruiting
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to compare two methods of giving epidural steroid injections for nerve pain in the arm that comes from the neck. An epidural steroid injection can be given in two different ways, either in the back of the spine within the neck or in the neck next to the nerve root going to the arm. Both are standard medical treatments. The investigators would like to see how effective these treatments are, and if there are any differences in effectiveness or safety between these two routes.

Condition or disease Intervention/treatment Phase
Cervicgenic Upper Extremity Radiculopathy Drug: dexamethasone Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Cervical Transforaminal Epidural Corticosteroid Injections With Lateralized Interlaminar Epidural Corticosteroid Injections for Treatment of Cervicogenic Upper Extremity Radiculopathy
Anticipated Study Start Date : February 1, 2018
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Transforaminal Cervical Epidural Corticosteroid Injections Drug: dexamethasone
0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds
Experimental: Lateralized Interlaminar Epidural Corticosteroid Injections Drug: dexamethasone
0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds


Outcome Measures

Primary Outcome Measures :
  1. Numerical Rating Scale (averaged over past 24 hours) [ Time Frame: 2 months ]
    The pain numerical rating scale (NRS) is a well-validated tool for quantitatively assessing patients' pain. The NRS asks patients to rate their current pain intensity on an 11-point scale ranging from 0 ("no pain") to 10 ("worst possible pain")


Secondary Outcome Measures :
  1. NRS (averaged over past 24 hours) [ Time Frame: 2 weeks ]
    The pain numerical rating scale (NRS) is a well-validated tool for quantitatively assessing patients' pain. The NRS asks patients to rate their current pain intensity on an 11-point scale ranging from 0 ("no pain") to 10 ("worst possible pain")

  2. NRS (averaged over past 24 hours) [ Time Frame: 4 months ]
    The pain numerical rating scale (NRS) is a well-validated tool for quantitatively assessing patients' pain. The NRS asks patients to rate their current pain intensity on an 11-point scale ranging from 0 ("no pain") to 10 ("worst possible pain")

  3. Change in NRS (averaged over past 24 hours) [ Time Frame: Baseline, 2 weeks, 2 months, 4 months ]
    The pain numerical rating scale (NRS) is a well-validated tool for quantitatively assessing patients' pain. The NRS asks patients to rate their current pain intensity on an 11-point scale ranging from 0 ("no pain") to 10 ("worst possible pain")

  4. Neck Disability Index (NDI) [ Time Frame: 2 weeks ]
    The NDI a well-validated measurement tool that contains 10 items: seven related to activities of daily living, two related to pain, and one related to concentration. Each item is scored from 0 to 5 and the total score is expressed as a percentage, with higher scores corresponding to greater disability.

  5. Neck Disability Index (NDI) [ Time Frame: 2 months ]
    The NDI a well-validated measurement tool that contains 10 items: seven related to activities of daily living, two related to pain, and one related to concentration. Each item is scored from 0 to 5 and the total score is expressed as a percentage, with higher scores corresponding to greater disability.

  6. Neck Disability Index (NDI) [ Time Frame: 4 months ]
    The NDI a well-validated measurement tool that contains 10 items: seven related to activities of daily living, two related to pain, and one related to concentration. Each item is scored from 0 to 5 and the total score is expressed as a percentage, with higher scores corresponding to greater disability.

  7. Change in Neck Disability Index (NDI) [ Time Frame: Baseline, 2 weeks, 2 months, 4 months ]
    The NDI a well-validated measurement tool that contains 10 items: seven related to activities of daily living, two related to pain, and one related to concentration. Each item is scored from 0 to 5 and the total score is expressed as a percentage, with higher scores corresponding to greater disability.

  8. EQ-5D [ Time Frame: 2 weeks ]
    EQ-5D is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal.

  9. EQ-5D [ Time Frame: 2 months ]
    EQ-5D is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal.

  10. EQ-5D [ Time Frame: 4 months ]
    EQ-5D is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal.

  11. Change in EQ-5D [ Time Frame: Baseline, 2 weeks, 2 months, 4 months ]
    EQ-5D is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal.

  12. Work Ability Index [ Time Frame: 2 week ]
    The Work Ability Index (WAI) is a validated, reliable measure of a worker's ability to do his or her job that has been shown to predict work disability, retirement and mortality.

  13. Work Ability Index [ Time Frame: 2 months ]
    The Work Ability Index (WAI) is a validated, reliable measure of a worker's ability to do his or her job that has been shown to predict work disability, retirement and mortality.

  14. Work Ability Index [ Time Frame: 4 months ]
    The Work Ability Index (WAI) is a validated, reliable measure of a worker's ability to do his or her job that has been shown to predict work disability, retirement and mortality.

  15. Change in Work Ability Index [ Time Frame: 2 week, 3 months, 4 months ]
    The Work Ability Index (WAI) is a validated, reliable measure of a worker's ability to do his or her job that has been shown to predict work disability, retirement and mortality.

  16. Frequency of minor Adverse Events [ Time Frame: immediately post-procedure ]
  17. Frequency of minor Adverse Events [ Time Frame: 2 days post procedure ]
  18. Frequency of major Adverse Events [ Time Frame: immediately post-procedure ]
  19. Frequency of major Adverse Events [ Time Frame: 2 days post procedure ]
  20. Frequency of contrast spread into the neuroforamen for each group [ Time Frame: During procedure ]
  21. Rate of inadvertent intravascular contrast injections [ Time Frame: During procedure ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unilateral cervicogenic upper extremity radiculopathy (with or without accompanying neck pain)
  • Baseline numerical pain scale (NRS) score > 4

Exclusion Criteria:

  • Recent (i.e., < 2 months) cervical spine surgery
  • Recent (i.e., < 1 month) cervical epidural or upper extremity corticosteroid injection
  • Contraindication or inability to the undergo procedure
  • Inability to provide informed consent
  • Expected inability to complete follow-up assessment
  • Contraindication to receiving contrast material (precluding an epidurogram)
Contacts and Locations

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): NCT03389620


Contacts
Contact: Timothy Amrhein, MD 919-684-7770 timothy.amrhein@duke.edu

Locations
United States, North Carolina
Duke Radiology and Orthopaedic Clinic Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Timothy Amrhein, MD    919-684-7770    timothy.amrhein@duke.edu   
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Timothy Amrhein, MD Duke University
More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03389620     History of Changes
Other Study ID Numbers: Pro00083262
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017

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 Duke University:
CT-fluoroscopy
Corticosteroid injection

Additional relevant MeSH terms:
Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Dexamethasone acetate
Dexamethasone
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