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Radicular; Neuropathic, CervicalPhase 4NCT02095197

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

A Phase 4 study testing Triamcinolone 80mg in people with Radicular; Neuropathic, Cervical and Neck Pain, run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Radicular; Neuropathic, Cervical, Neck Pain
What is being tested?
Triamcinolone 80mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
1 siteUnited States
Study dates
Mar 2014to Jul 2016
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Triamcinolone 80mg
Medical subject headings
Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Triamcinolone 80mgDrug

    Also called Kenalog

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

Study groups in NCT02095197
Study groupRoleWhat they receive
No Catheter deliveryOtherCervical 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.
Receives: Drug: Triamcinolone 80mg
Catheter targeted deliveryActive comparatorCervical 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.
Receives: Drug: Triamcinolone 80mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With ≥50% Pain Reduction on the Numeric Rating Score (NRS) for Pain

    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)

    Measured: 1 month

Secondary outcomes (3)

  1. Decrease of > 6.8 Point Reduction in Medication Quntification Scale (MQS-III)

    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).

    Measured: 1 month

  2. Patient Global Impression of Change Score (PGIC) Less Than 3

    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."

    Measured: 1 month

  3. Greater Than or Equal to a 30% Reduction in Oswestry Neck Disability Index Score

    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.

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionJul 2016
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02095197
Sponsor's protocol ID
STU00089080
Other IDs
STU00089080
Status last verified
Feb 2017
First submitted
20 Mar 2014
Last updated
28 Mar 2017
Data monitoring committee
No
Individual data sharing
No

Publications

  • McCormick ZL, Nelson A, Bhave M, Zhukalin M, Kendall M, McCarthy RJ, Khan D, Nagpal G, Walega DR. A Prospective Randomized Comparative Trial of Targeted Steroid Injection Via Epidural Catheter Versus Standard C7-T1 Interlaminar Approach for the Treatment of Unilateral Cervical Radicular Pain. Reg Anesth Pain Med. 2017 Jan-Feb;42(1):82-89. doi: 10.1097/AAP.0000000000000521.

    PubMed 27922950

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Triamcinolone 80mg in people with Radicular; Neuropathic, Cervical and Neck Pain, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With ≥50% Pain Reduction on the Numeric Rating Score (NRS) for Pain (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02095197, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2017.

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