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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
169
Nortriptyline up to 125 mg po qhs, and / or Gabapentin up to 1200 mg po q8h, Physical therapy (e.g. range of motion, strengthening, therapeutic massage, TENS)
Series of up to 3 cervical epidural steroid injections (ESI) with depo-methylprednisolone
Series of up to 3 cervical epidural steroid injections with depo- methylprednisolone plus Nortriptyline up to 125 mg po qhs and /or Gabapentin up to 1200 mg po q8h, and Physical therapy (e.g. TENS, exercise, range of motion)
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Johns Hopkins Medical Institutions
Baltimore, Maryland, United States
numerical rating scale (NRS) arm pain scores
arm pain on a 0-10 scale
Time frame: 1 month after treatment
NRS Arm pain
0-10 scale
Time frame: 3 months
NRS arm pain
0-10 scale
Time frame: 6 months
NRS neck pain
0-10 scale
Time frame: 1- month
NRS neck pain
0-10 scale
Time frame: 3 months
NRS neck pain
0-10 scale
Time frame: 6 months
medication reduction
Cessation of non-opioid analgesic and/ or \> 20% decrease in opioid consumption
Time frame: 1-6 months
Global perceived effect
categorical variable assessing "satisfaction" with treatment
Time frame: 1-6 months
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