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Conservative Therapy Versus Epidural Steroids for Cervical Radiculopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01144923
Recruitment Status : Completed
First Posted : June 16, 2010
Last Update Posted : April 24, 2014
Sponsor:
Collaborator:
Walter Reed Army Medical Center
Information provided by (Responsible Party):
Steven P. Cohen, Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE June 14, 2010
First Posted Date  ICMJE June 16, 2010
Last Update Posted Date April 24, 2014
Study Start Date  ICMJE June 2010
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2010)
numerical rating scale (NRS) arm pain scores [ Time Frame: 1 month after treatment ]
arm pain on a 0-10 scale
Original Primary Outcome Measures  ICMJE
 (submitted: June 15, 2010)
numerical rating scale arm pain scores [ Time Frame: 1 month after treatment ]
arm pain on a 0-10 scale
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2012)
  • NRS Arm pain [ Time Frame: 3 months ]
    0-10 scale
  • NRS arm pain [ Time Frame: 6 months ]
    0-10 scale
  • NRS neck pain [ Time Frame: 1- month ]
    0-10 scale
  • NRS neck pain [ Time Frame: 3 months ]
    0-10 scale
  • NRS neck pain [ Time Frame: 6 months ]
    0-10 scale
  • medication reduction [ Time Frame: 1-6 months ]
    Cessation of non-opioid analgesic and/ or > 20% decrease in opioid consumption
  • Global perceived effect [ Time Frame: 1-6 months ]
    categorical variable assessing "satisfaction" with treatment
Original Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2010)
  • numerical rating scale neck pain [ Time Frame: 1 month post-treatment ]
    neck pain
  • NRS arm pain [ Time Frame: 3 months after treatment ]
    pain in arm
  • NRS arm pain [ Time Frame: 6 months after treatment ]
    pain in arm
  • numerical rating scale neck pain [ Time Frame: 3 months post-treatment ]
    neck pain
  • numerical rating scale neck pain [ Time Frame: 6 months post-treatment ]
    neck pain
  • Neck disability index [ Time Frame: 1-month post-treatment ]
    functional capacity
  • Neck disability index [ Time Frame: 3-months post-treatment ]
    functional capacity
  • Neck disability index [ Time Frame: 6 months post-treatment ]
    functional capacity
  • Global perceived effect [ Time Frame: 1-month post-treatment ]
    satisfaction measure
  • global perceived effect [ Time Frame: 3 months post-treatment ]
    satisfaction measure
  • global perceived effect [ Time Frame: 6 months post-treatment ]
    satisfaction measure
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Conservative Therapy Versus Epidural Steroids for Cervical Radiculopathy
Official Title  ICMJE Randomized, Comparative-effectiveness Study Comparing Epidural Steroid Injections to Conservative Management With Medications and Physical Therapy in Patients With Cervical Radiculopathy
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cervical Radiculopathy
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • 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)
    Intervention: Other: Gabapentin and/or Nortriptyline, Physical therapy
  • Experimental: Epidural Steroids
    A series of up to 3 epidural steroid injections (ESI)with depo-methylprednisolone
    Intervention: Procedure: Epidural Steroid Injections (ESI)
  • 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)
    Intervention: Other: Combination treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2014)
169
Original Estimated Enrollment  ICMJE
 (submitted: June 15, 2010)
168
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01144923
Other Study ID Numbers  ICMJE NA_00036062
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Steven P. Cohen, Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Walter Reed Army Medical Center
Investigators  ICMJE
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
PRS Account Johns Hopkins University
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP