Conservative Therapy Versus Epidural Steroids for Cervical Radiculopathy

Study Overview
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Brief Summary
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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.

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

Conditions
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Cervical Radiculopathy

Intervention / Treatment
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* Other: Gabapentin and/or Nortriptyline, Physical therapy
* Procedure: Epidural Steroid Injections (ESI)
* Other: Combination treatment


Participation Criteria
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Eligibility Criteria
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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 Serious medical (e.g. congestive heart failure) or psychiatric (untreated depression) condition that might preclude optimal outcome Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conservative treatment<br>Pharmacotherapy with nortriptyline and/ or gabapentin, physical therapy (e.g. range of motion, therapeutic massage, strengthening exercises), and possibly others (e.g. acupuncture) | Other: Gabapentin and/or Nortriptyline, Physical therapy<br>* 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)<br>|
| Experimental: Epidural Steroids<br>A series of up to 3 epidural steroid injections (ESI)with depo-methylprednisolone | Procedure: Epidural Steroid Injections (ESI)<br>* Series of up to 3 cervical epidural steroid injections (ESI) with depo-methylprednisolone<br>|
| Experimental: Combination Treatment<br>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) | Other: Combination treatment<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| numerical rating scale (NRS) arm pain scores | arm pain on a 0-10 scale | 1 month after treatment | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epidural steroid injection, neck pain, pharmacotherapy, radiculopathy