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Completed

NCT Number: NCT01144923

Conservative Therapy Versus Epidural Steroids for 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.

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Key information

Conditions

Cervical Radiculopathy Neck Pain Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Radiculopathy Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Walter Reed Army Medical Center, Washington D.C., District of Columbia, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.)
  • NRS arm pain score > 3
  • MRI evidence of disc pathology consistent with symptoms

Exclusion criteria

  • Untreated coagulopathy
  • Previous spine surgery
  • No MRI study
  • Arm pain > 4 years duration
  • Epidural steroid injection within past 3 years
  • Radiculopathy not resulting from disc pathology (e.g. foraminal stenosis or tumor)
  • Signs or symptoms or myelopathy or spinal cord compression
  • Previous failed trials with gabapentin or pregabalin, and nortriptyline or amitriptyline
  • Allergic reactions to gabapentin or nortriptyline
  • Referrals from surgery for diagnostic injections for surgical evaluation
  • Serious medical (e.g. congestive heart failure) or psychiatric (untreated depression) condition that might preclude optimal outcome
  • Pregnancy

Treatment and study plan

Gabapentin and/or Nortriptyline, Physical therapy

Other

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)

Epidural Steroid Injections (ESI)

Procedure

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

Combination treatment

Other

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)

Primary outcomes

  1. numerical rating scale (NRS) arm pain scores

    Time frame: 1 month after treatment

    arm pain on a 0-10 scale

Secondary outcomes

  1. NRS Arm pain

    Time frame: 3 months

    0-10 scale

  2. NRS arm pain

    Time frame: 6 months

    0-10 scale

  3. NRS neck pain

    Time frame: 1- month

    0-10 scale

  4. NRS neck pain

    Time frame: 3 months

    0-10 scale

  5. NRS neck pain

    Time frame: 6 months

    0-10 scale

  6. medication reduction

    Time frame: 1-6 months

    Cessation of non-opioid analgesic and/ or > 20% decrease in opioid consumption

  7. Global perceived effect

    Time frame: 1-6 months

    categorical variable assessing "satisfaction" with treatment

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Walter Reed Army Medical Center

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jun 16, 2010
Registry last updated
Apr 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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