Surgery Prevention by Transforaminal Injection of Epidural Steroids for Cervical Radicular Pain
Condition: Pain, Radiating
MeSH terms: Pain
Intervention: Lidocaine; Lidocaine with Dexamethasone
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Lidocaine; BB 1101
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cervical; radicular pain; transforaminal epidural steroid injections

Summary:

      Cervical radicular pain is a common cause of disability and pain in the upper extremity and
      neck with an annual incidence of 83.2/100,000 (1). The initial treatment is conservative and
      includes relative rest, use of anti-inflammatory and analgesic medication, as well as
      physical therapy and home exercise. For patients who have persistent and significant
      symptoms, interventional pain management and surgical management are considered. Cervical
      epidural injections are the mainstay of the interventional, non-surgical modalities. They can
      be considered to provide short and long-term relief when disc herniation, foraminal stenosis
      or central canal stenosis pathology is identified. We are not aware of any published
      prospective, randomized, controlled, double-blinded studies demonstrating the efficacy of
      cervical transforaminal epidural steroid injections. However, the North American Spine
      Society (NASS) Review and Recommendation Statement states that based on the literature and
      expert opinion, a minimum of one or two cervical epidural steroid injections would be very
      appropriate in the treatment of a specific episode of cervical radicular pain.

      The purpose of this study is to determine the effectiveness of cervical transforaminal
      epidural steroid injections in decreasing the need for an operation in patients with cervical
      radicular pain, otherwise considered to be operative candidates.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who have cervical radicular pain without significant neurologic deficit
             (neurologic deficit is defined as manual muscle testing less than 3/5), MRI/CT
             findings of neural compression (neural compression is defined as disc herniation or
             central or foraminal spinal stenosis),

          -  Failed 6 weeks of conservative treatment (conservative treatment is defined as
             relative rest, home exercise, physical therapy, and use of anti-inflammatory and/or
             analgesic medications),

          -  Deemed to be good operative candidates by spine surgeons (patients with MRI/CT
             findings of neural compression with concordant symptoms) and had agreed to possible
             operative intervention

        Exclusion Criteria:

          -  History of

               1. acute trauma,

               2. diabetes (type I or type II),

               3. active infection

          -  Active progressive neurological deficit (neurologic is deficit defined as manual
             muscle testing less than 3/5),

          -  Medical condition that may affect the cervical spine neurological exam and/or pain
             assessment (e.g. peripheral neuropathy),

          -  Bilateral disease,

          -  More than one cervical level requiring injection,

          -  Bleeding disorders or other medical contraindications to the injection procedure,

          -  Absence of substantial radicular pain (radicular pain is defined as arm pain greater
             than neck pain),

          -  Involvement in workers' compensation claim, or any litigation related to neck injury.

          -  Patients who are pregnant, or who plan to become pregnant in the next 12 months