Cervical Radiculopathy
Conditions
Keywords
epidural steroid injection, neck pain, pharmacotherapy, radiculopathy
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.
Interventions
OTHERGabapentin and/or Nortriptyline, Physical therapy
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)
PROCEDUREEpidural Steroid Injections (ESI)
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)
Sponsors
Walter Reed Army Medical Center
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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.) 2. NRS arm pain score \> 3 3. MRI evidence of disc pathology consistent with symptoms
Exclusion criteria
1. Untreated coagulopathy 2. Previous spine surgery 3. No MRI study 4. Arm pain \> 4 years duration 5. Epidural steroid injection within past 3 years 6. Radiculopathy not resulting from disc pathology (e.g. foraminal stenosis or tumor) 7. Signs or symptoms or myelopathy or spinal cord compression 8. Previous failed trials with gabapentin or pregabalin, and nortriptyline or amitriptyline 9. Allergic reactions to gabapentin or nortriptyline 10. Referrals from surgery for diagnostic injections for surgical evaluation 11. Serious medical (e.g. congestive heart failure) or psychiatric (untreated depression) condition that might preclude optimal outcome 12. Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| numerical rating scale (NRS) arm pain scores | 1 month after treatment | arm pain on a 0-10 scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 1- month | 0-10 scale |
Countries
United States
Outcome results
None listed