Principal Investigator: Zachary McCormick
Keywords: Cervical Radicular Pain , Cervical Transforaminal Epidural Steroid Injection , Prospective trial Department: Physical Medicine & Rehab
IRB Number: 00116040 Co Investigator: Aaron Conger
Specialty: Physical Medicine and Rehabilitation
Sub Specialties: Neck
Recruitment Status: Recruiting

Contact Information

Shellie Cunningham

Simple Summary

Any patient with cervical radicular pain meeting criteria who is undergoing cervical transforaminal steroid injection (TFESI) will be offered enrollment. The goal is to provide high quality data on short and long-term measures of pain, function, sleep quality, and analgesic medication use after TFESI. Clinic visit or telephone call will occur at 4 weeks, 8 weeks, 3 months, 6 months, and 12 months, at which times all follow-up measures of pain, function, sleep quality, and analgesic medication use will be collected. Participants who achieve 80% or more relief of their usual pain at the 4-week follow-up and who subsequently experience a recurrence of their usual index pain will be offered a repeat procedure. Participants with 50-79% relief will be offered a second injection (at 4-week follow-up) with the goal of achieving greater than 80% relief. Responders will be offered a repeat injection if pain returns to the extent that warrants consideration of an additional injection. Participants will be allowed up to 3 injections during any 6-month period of the study and up to 4 injections during the total one-year study period.

Inclusion Criteria

Inclusion Criteria:

  • Adult patients aged >18 capable of understanding and providing consent in English and capable of complying with the outcome instruments used.
  • Arm pain or shoulder girdle pain/periscapular pain with or without neck pain with duration less than or equal to 6 months.
  • 3-day average numeric pain rating score (NRS) for arm pain or shoulder girdle/periscapular pain of at least 4/10 at baseline evaluation, with neck pain score not exceeding arm and/or shoulder girdle/periscapular pain score.
  • MRI (or CT if MRI not available) shows either a one level cervical disc herniation, disc osteophyte complex or degenerative foraminal stenosis, corresponding in side and location with predominately unilateral radicular pain, with or without neurological deficits. MRI may show degenerative changes at other levels.
  • Patient consents to treatment with epidural injection in a shared decision-making process with the treating physician.
  • Pain duration of at least 6 weeks or more.

Exclusion Criteria

Exclusion Criteria:

  • Those receiving remuneration for their pain treatment (e.g., disability, worker’s compensation).
  • Those involved in active litigation relevant to their pain.
  • The patient is incarcerated.
  • Neck pain is greater than arm pain or shoulder girdle/periscapular pain.
  • Bilateral radicular signs/symptoms (< 90% laterality of pain intensity, or bilateral neurological signs).
  • BMI>35.
  • Prior epidural steroid injections for treatment of current episode.
  • Those unable to read English and complete the assessment instruments.
  • Spondylolisthesis at the involved or adjacent segments.
  • Systemic inflammatory arthritis (e.g., rheumatoid, lupus).
  • Addictive behavior, severe clinical depression, or psychotic features.
  • Possible pregnancy or other reason that precludes the use of fluoroscopy.
  • Treatment of infection with antibiotics within the past 7 days.
  • Progressive motor deficit and/or clinical signs of myelopathy.
  • History of prior cervical spine surgery.
  • Medical conditions causing significant functional disability (e.g., stroke, COPD)

Participant Reimbursement

There are no direct benefits or reimbursement to the individual by participating in this study. The patients will be presented with the same options of treatment whether they enroll in the study or decide not to.