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Clinical Trials/NCT01144923
NCT01144923
Completed
N/A

Randomized, Comparative-effectiveness Study Comparing Epidural Steroid Injections to Conservative Management With Medications and Physical Therapy in Patients With Cervical Radiculopathy

Johns Hopkins University2 sites in 1 country169 target enrollmentJune 2010

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cervical Radiculopathy
Sponsor
Johns Hopkins University
Enrollment
169
Locations
2
Primary Endpoint
numerical rating scale (NRS) arm pain scores
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

The main objective of this study is to determine whether interventional treatment (i.e. epidural steroids), conservative therapy, or the combination, is superior for cervical radiculopathy. One hundred and sixty eight patients with radicular neck pain will be randomized in a 1:1:1 ratio to receive either cervical epidural steroid injections (CESI), non-interventional management with physical therapy and medications, or a combination of the two. The first follow-up visit will be at 1-month. In patients who obtain some benefit but continue to report significant pain, either a 2nd CESI can be done, the patient's medications can be adjusted, or both in the combination group. Those patients who fail to obtain any benefit will exit the study to receive another treatment or alternative care. The second follow-up visit will be at 3-months. Similar to the 1-month follow-up, the doctor may elect to change nothing in patients who are satisfied, adjust medications, schedule the patient for another CESI, or do both in the combination group. Patients who fail to obtain any benefit can exit the study to receive alternative treatment. The final follow-up visit will be at 6 months.

Registry
clinicaltrials.gov
Start Date
June 2010
End Date
November 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Steven P. Cohen

Professor

Johns Hopkins University

Eligibility Criteria

Inclusion Criteria

  • Cervical radicular pain based on history and physical exam (e.g. pain radiating into one or both extremities, sensory loss, muscle weakness, Spurling's test etc.)
  • NRS arm pain score \> 3
  • MRI evidence of disc pathology consistent with symptoms

Exclusion Criteria

  • Untreated coagulopathy
  • Previous spine surgery
  • No MRI study
  • Arm pain \> 4 years duration
  • Epidural steroid injection within past 3 years
  • Radiculopathy not resulting from disc pathology (e.g. foraminal stenosis or tumor)
  • Signs or symptoms or myelopathy or spinal cord compression
  • Previous failed trials with gabapentin or pregabalin, and nortriptyline or amitriptyline
  • Allergic reactions to gabapentin or nortriptyline
  • Referrals from surgery for diagnostic injections for surgical evaluation

Outcomes

Primary Outcomes

numerical rating scale (NRS) arm pain scores

Time Frame: 1 month after treatment

arm pain on a 0-10 scale

Secondary Outcomes

  • medication reduction(1-6 months)
  • Global perceived effect(1-6 months)
  • NRS Arm pain(3 months)
  • NRS arm pain(6 months)
  • NRS neck pain(6 months)

Study Sites (2)

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