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Conservative Therapy Versus Epidural Steroids for Cervical Radiculopathy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Walter Reed Army Medical Center
Information provided by (Responsible Party):
Steven P. Cohen, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01144923
First received: June 14, 2010
Last updated: April 1, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Comparative-effectiveness Study Comparing Epidural Steroid Injections to Conservative Management With Medications and Physical Therapy in Patients With Cervical Radiculopathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • numerical rating scale (NRS) arm pain scores [ Time Frame: 1 month after treatment ] [ Designated as safety issue: No ]
    arm pain on a 0-10 scale


Secondary Outcome Measures:
  • NRS Arm pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    0-10 scale

  • NRS arm pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    0-10 scale

  • NRS neck pain [ Time Frame: 1- month ] [ Designated as safety issue: No ]
    0-10 scale

  • NRS neck pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    0-10 scale

  • NRS neck pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    0-10 scale

  • medication reduction [ Time Frame: 1-6 months ] [ Designated as safety issue: No ]
    Cessation of non-opioid analgesic and/ or > 20% decrease in opioid consumption

  • Global perceived effect [ Time Frame: 1-6 months ] [ Designated as safety issue: No ]
    categorical variable assessing "satisfaction" with treatment


Estimated Enrollment: 168
Study Start Date: June 2010
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01144923

Locations
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307
United States, Maryland
Johns Hopkins Medical Institutions
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
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
  More Information

Publications:

Responsible Party: Steven P. Cohen, Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01144923     History of Changes
Other Study ID Numbers: NA_00036062
Study First Received: June 14, 2010
Last Updated: April 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
epidural steroid injection
neck pain
pharmacotherapy
radiculopathy

Additional relevant MeSH terms:
Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Nortriptyline
Gabapentin
Anti-Inflammatory Agents
Therapeutic Uses
 Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Adrenergic Uptake Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013