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C7-T1 Epidural Steroid Injections Versus Targeted Injection for Treatment of Cervical Radicular Pain

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ClinicalTrials.gov Identifier: NCT02095197
Recruitment Status : Completed
First Posted : March 24, 2014
Results First Posted : March 28, 2017
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
David Walega, Northwestern University

Brief Summary:
Cervical radicular pain is a common, disabling problem, occurs in 83:100,000 individuals per year. Symptoms are most often caused by intervertebral disc herniation (21.9%) or central or foraminal stenosis from spondylosis (68.4%). Patients complain of pain in the head, neck, scapula or arm. The diagnosis of radicular pain is made clinically by history and physical examination, supported by imaging studies and electrodiagnostic tests. No study has compared the differences in pain, medication utilization, functional outcomes, or patient satisfaction between interlaminar and targeted epidural injections in the cervical spine. In theory, the technique of targeted epidural steroid delivery with a catheter has a lower risk of accidental vascular trespass or disc penetration during the procedure, and far less risk of dural penetration or spinal cord injury at rostral levels of the cervical spinal cord as compared with the interlaminar technique. The investigators hypothesize that this technique results in superior pain control, decreased medication use, improved function and fewer repeat injections. This data could improve patient safety and affect the evolving treatment guidelines for cervical epidural injections.

Condition or disease Intervention/treatment Phase
Radicular; Neuropathic, Cervical Neck Pain Drug: Triamcinolone 80mg Phase 4

Detailed Description:
Cervical radicular pain is a common, painful, disabling problem, often treated by epidural steroid injection (ESI). Two techniques of steroid delivery into the cervical epidural space include the transforaminal and interlaminar approaches. We aimed to determine if the CIESI with versus without a catheter is associated with superior clinical outcomes at follow-up. We hypothesized that the use of a targeted epidural catheter technique would result in superior pain control, function, decreased analgesic use, and lower surgical incidence as compared to standard CIESI at C7-T1.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Controlled Trial of Standardized C7-T1 Epidural Steroid Injections Versus Targeted Injection Via Cervical Epidural Catheter for the Treatment of Cervical Radicular Pain
Study Start Date : March 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016


Arm Intervention/treatment
No Catheter delivery

Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.

No Catheter Delivery will be used to deliver the medication.

Drug: Triamcinolone 80mg
C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.
Other Name: Kenalog

Active Comparator: Catheter targeted delivery

Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.

Catheter targeted delivery will be used to deliver the medication.

Drug: Triamcinolone 80mg
C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.
Other Name: Kenalog




Primary Outcome Measures :
  1. Percentage of Participants With ≥50% Pain Reduction on the Numeric Rating Score (NRS) for Pain [ Time Frame: 1 month ]

    The percentage of participants who reported ≥50% pain reduction on the numeric rating score for pain at the 1 month follow-up assessment period.

    Numeric Rating Scale (NRS) for pain consists of a range where 0 (is no pain) and 10 (is extreme pain).

    Percentage of participants with pain reduction = 100% (number of participants with pain reduction/all participants)



Secondary Outcome Measures :
  1. Decrease of > 6.8 Point Reduction in Medication Quntification Scale (MQS-III) [ Time Frame: 1 month ]
    The Medication Quantification Scale was designed as a method of quantifying different drug regimens (Harden et al, Journal of Pain, 2005). The detriment weights derived from the healthcare survey for each of the 22 medication classes are the critical values that when multiplied by a dosage score it gives a patient MQS score. It computes a single numeric value for a patient's pain medication profile. We recorded the names and doses of each medication being used then quantified the total burden of each subject's medication using the MQS-III. which assigns a measurement to each drug based on both the dose taken and its burdensomeness (derived from expert consensus).

  2. Patient Global Impression of Change Score (PGIC) Less Than 3 [ Time Frame: 1 month ]

    PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as:

    1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No Change, 5=Minimally Worse, 6=Much Worse, 7=Very Much Worse.

    A PGIC score less than 3 means the patient reported "much improved" to "very much improved."


  3. Greater Than or Equal to a 30% Reduction in Oswestry Neck Disability Index Score [ Time Frame: 1 month ]
    This questionnaire has been designed to give us information to how neck pain has affected the ability to manage in everyday life. There are ten sections, 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. All the points can be summed to a total score. The maximum points scored is 50. The reported score divided by 50 is then transformed to a percentage score by multiplying by 100. The Minimum dectectable change (90 % confidence) is 5 points or 10 percent.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients ages 18-75 with C2-6 unilateral radicular pain who are scheduled to undergo cervical epidural steroid injection treatment.
  • Pain lasting greater than 2 weeks.
  • Pain resistant to a trial of conservative therapy (i.e. oral steroids,nonsteroidal anti-inflammatory drugs, opioids, muscle relaxants, physical therapy or chiropractic care)

Exclusion Criteria:

  • Patient refusal.
  • Lack of consent.
  • Systemic infection or local infection over planned injection site in posterior cervical spine.
  • Bleeding disorder, current use of anticoagulants or anti-platelet medications.
  • Intrinsic spinal cord lesions in the cervical region.
  • History of central neurologic, cerebrovascular, demyelinating or muscular disease.
  • Concomitant use of oral or injected steroids.
  • Allergy to medications being used for injection procedures.
  • Inability to communicate with staff or to participate in follow up.
  • Pregnancy.
  • Inability to perform handgrip or arm strength testing.
  • Cognitive deficit or motor neuron disease.
  • Daily opiate use that preceded the onset of cervical radicular symptoms or daily opiate use exceeding 3 months prior to study inclusion

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): NCT02095197


Locations
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United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: David R Walega, M.D. Northwestern University Feinberg School of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: David Walega, Associate Professor of Anesthesiology, Northwestern University
ClinicalTrials.gov Identifier: NCT02095197     History of Changes
Other Study ID Numbers: STU00089080
STU00089080 ( Other Identifier: Northwestern University IRB )
First Posted: March 24, 2014    Key Record Dates
Results First Posted: March 28, 2017
Last Update Posted: March 28, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Neuromuscular Diseases
Lidocaine
Radiculopathy
Neck Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Peripheral Nervous System Diseases
Nervous System Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors