Conservative Therapy Versus Epidural Steroids for Cervical Radiculopathy

Johns Hopkins University

Status: Completed

Conditions: Cervical Radiculopathy

Treatments: Other: Gabapentin and/or Nortriptyline, Physical therapy; Other: Combination treatment; Procedure: Epidural Steroid Injections (ESI)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01144923

NA_00036062

Details and patient eligibility

About

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.

Enrollment: 169 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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169 participants in 3 patient groups

Conservative treatment

Active Comparator group

Description:

Pharmacotherapy with nortriptyline and/ or gabapentin, physical therapy (e.g. range of motion, therapeutic massage, strengthening exercises), and possibly others (e.g. acupuncture)

Treatment:

Other: Gabapentin and/or Nortriptyline, Physical therapy

Epidural Steroids

Experimental group

Description:

A series of up to 3 epidural steroid injections (ESI)with depo-methylprednisolone

Treatment:

Procedure: Epidural Steroid Injections (ESI)

Combination Treatment

Experimental group

Description:

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)

Treatment:

Other: Combination treatment