Conservative Therapy Versus Epidural Steroids for Cervical Radiculopathy

April 23, 2014 updated by: Steven P. Cohen, Johns Hopkins University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

169

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20307
        • Walter Reed Army Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins Medical Institutions

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conservative treatment
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
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)
Experimental: Epidural Steroids
A series of up to 3 epidural steroid injections (ESI)with depo-methylprednisolone
Procedure: Epidural Steroid Injections (ESI)
Series of up to 3 cervical epidural steroid injections (ESI) with depo-methylprednisolone
Experimental: 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)
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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Walter Reed Army Medical Center

Investigators

  • Study Director: Steven P Cohen, MD, Johns Hopkins University
  • Principal Investigator: Salim Hayek, MD, PhD, Case Western
  • Principal Investigator: Rick Fisher, MD, Walter Reed National Military Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

June 14, 2010

First Submitted That Met QC Criteria

June 15, 2010

First Posted (Estimate)

June 16, 2010

Study Record Updates

Last Update Posted (Estimate)

April 24, 2014

Last Update Submitted That Met QC Criteria

April 23, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00036062

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cervical Radiculopathy

Clinical Trials on Gabapentin and/or Nortriptyline, Physical therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe