Conservative Therapy Versus Epidural Steroids for Cervical Radiculopathy

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.

Conditions

• Cervical Radiculopathy

Interventions

OTHER

Gabapentin 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)

PROCEDURE

Epidural Steroid Injections (ESI)

Series of up to 3 cervical epidural steroid injections (ESI) with depo-methylprednisolone

OTHER

Combination treatment

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 & Collaborators

• Walter Reed Army Medical Center

  collaborator FED

• Johns Hopkins University

  lead OTHER

Principal Investigators

• Steven P Cohen, MD · Johns Hopkins University

• Salim Hayek, MD, PhD · Case Western

• Rick Fisher, MD · Walter Reed National Military Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-06-30

Primary Completion

2013-11-30

Completion

2013-11-30

Countries

• United States

Study Locations