Conservative Therapy Versus Epidural Steroids for Cervical Radiculopathy
- Conditions
- Cervical Radiculopathy
- Interventions
- Other: Gabapentin and/or Nortriptyline, Physical therapyProcedure: Epidural Steroid Injections (ESI)Other: Combination treatment
- Registration Number
- NCT01144923
- Lead Sponsor
- Johns Hopkins University
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 169
- 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
- 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
- Serious medical (e.g. congestive heart failure) or psychiatric (untreated depression) condition that might preclude optimal outcome
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conservative treatment Gabapentin and/or Nortriptyline, Physical therapy Pharmacotherapy with nortriptyline and/ or gabapentin, physical therapy (e.g. range of motion, therapeutic massage, strengthening exercises), and possibly others (e.g. acupuncture) Epidural Steroids Epidural Steroid Injections (ESI) A series of up to 3 epidural steroid injections (ESI)with depo-methylprednisolone Combination Treatment Combination treatment These patients will receive both treatments. They can have up to 3 epidural steroid injections (ESI) with depo-methylprednisolone, and conservative treatment (i.e. pharmacotherapy with nortriptyline and/ or gabapentin, and physical therapy)
- Primary Outcome Measures
Name Time Method numerical rating scale (NRS) arm pain scores 1 month after treatment arm pain on a 0-10 scale
- Secondary Outcome Measures
Name Time Method medication reduction 1-6 months Cessation of non-opioid analgesic and/ or \> 20% decrease in opioid consumption
Global perceived effect 1-6 months categorical variable assessing "satisfaction" with treatment
NRS Arm pain 3 months 0-10 scale
NRS arm pain 6 months 0-10 scale
NRS neck pain 6 months 0-10 scale
Trial Locations
- Locations (2)
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Johns Hopkins Medical Institutions
🇺🇸Baltimore, Maryland, United States