Clinical Trial: Conservative Therapy Versus Epidural Steroids for Cervical Radiculopathy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Johns Hopkins University

Current Primary Outcome: numerical rating scale (NRS) arm pain scores [ Time Frame: 1 month after treatment ]

arm pain on a 0-10 scale


Original Primary Outcome: numerical rating scale arm pain scores [ Time Frame: 1 month after treatment ]

arm pain on a 0-10 scale


Current Secondary Outcome:

  • NRS Arm pain [ Time Frame: 3 months ]
    0-10 scale
  • NRS arm pain [ Time Frame: 6 months ]
    0-10 scale
  • NRS neck pain [ Time Frame: 1- month ]
    0-10 scale
  • NRS neck pain [ Time Frame: 3 months ]
    0-10 scale
  • NRS neck pain [ Time Frame: 6 months ]
    0-10 scale
  • medication reduction [ Time Frame: 1-6 months ]
    Cessation of non-opioid analgesic and/ or > 20% decrease in opioid consumption
  • Global perceived effect [ Time Frame: 1-6 months ]
    categorical variable assessing "satisfaction" with treatment


Original Secondary Outcome:

  • numerical rating scale neck pain [ Time Frame: 1 month post-treatment ]
    neck pain
  • NRS arm pain [ Time Frame: 3 months after treatment ]
    pain in arm
  • NRS arm pain [ Time Frame: 6 months after treatment ]
    pain in arm
  • numerical rating scale neck pain [ Time Frame: 3 months post-treatment ]
    neck pain
  • numerical rating scale neck pain [ Time Frame: 6 months post-treatment ]
    neck pain
  • Neck disability index [ Time Frame: 1-month post-treatment ]
    functional capacity
  • Neck disability index [ Time Frame: 3-months post-treatment ]
    functional capacity
  • Neck disability index [ Time Frame: 6 months post-treatment ]
    functional capacity
  • Global perceived effect [ Time Frame: 1-month post-treatment ]
    satisfaction measure
  • global perceived effect [ Time Frame: 3 months post-treatment ]
    satisfaction measure
  • global perceived effect [ Time Frame: 6 months post-treatment ]
    satisfaction measure


Information By: Johns Hopkins University

Dates:
Date Received: June 14, 2010
Date Started: June 2010
Date Completion:
Last Updated: April 23, 2014
Last Verified: April 2014