Conservative Therapy Versus Epidural Steroids for Cervical Radiculopathy

NCT01144923 | Completed DMC

• 1 other identifier: NA_00036062
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 2

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.

Conditions

Cervical Radiculopathy

Keywords

epidural steroid injection; neck pain; pharmacotherapy; radiculopathy

Outcome Measures

Primary Outcomes (1)

• numerical rating scale (NRS) arm pain scores

  arm pain on a 0-10 scale

  1 month after treatment

Secondary Outcomes (7)

• NRS Arm pain

  3 months

• NRS arm pain

  6 months

• NRS neck pain

  1- month

• NRS neck pain

  3 months

• NRS neck pain

  6 months

Study Arms (3)

Conservative treatment

ACTIVE COMPARATOR

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

Epidural Steroids

EXPERIMENTAL

A series of up to 3 epidural steroid injections (ESI)with depo-methylprednisolone

Procedure: Epidural Steroid Injections (ESI)

Combination Treatment

EXPERIMENTAL

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

Interventions

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)

Conservative treatment

Epidural Steroid Injections (ESI) PROCEDURE

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

Epidural Steroids

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)

Combination Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Walter Reed Army Medical Center: collaborator

Study Sites (2)

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

Location

Johns Hopkins Medical Institutions

Baltimore, Maryland, 21205, United States

Location

Related Publications (3)

• Hogg-Johnson S, van der Velde G, Carroll LJ, Holm LW, Cassidy JD, Guzman J, Cote P, Haldeman S, Ammendolia C, Carragee E, Hurwitz E, Nordin M, Peloso P; Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. The burden and determinants of neck pain in the general population: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Spine (Phila Pa 1976). 2008 Feb 15;33(4 Suppl):S39-51. doi: 10.1097/BRS.0b013e31816454c8.

  PMID: 18204398 BACKGROUND

• Carragee EJ, Hurwitz EL, Cheng I, Carroll LJ, Nordin M, Guzman J, Peloso P, Holm LW, Cote P, Hogg-Johnson S, van der Velde G, Cassidy JD, Haldeman S; Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Treatment of neck pain: injections and surgical interventions: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Spine (Phila Pa 1976). 2008 Feb 15;33(4 Suppl):S153-69. doi: 10.1097/BRS.0b013e31816445ea.

  PMID: 18204388 BACKGROUND

• Hurwitz EL, Carragee EJ, van der Velde G, Carroll LJ, Nordin M, Guzman J, Peloso PM, Holm LW, Cote P, Hogg-Johnson S, Cassidy JD, Haldeman S; Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Treatment of neck pain: noninvasive interventions: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Spine (Phila Pa 1976). 2008 Feb 15;33(4 Suppl):S123-52. doi: 10.1097/BRS.0b013e3181644b1d.

  PMID: 18204386 BACKGROUND

MeSH Terms

Conditions

Radiculopathy; Neck Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Steven P Cohen, MD

  Johns Hopkins University

  STUDY DIRECTOR

• Salim Hayek, MD, PhD

  Case Western

  PRINCIPAL INVESTIGATOR

• Rick Fisher, MD

  Walter Reed National Military Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 14, 2010
• First Posted: June 16, 2010
• Study Start: June 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: April 24, 2014

Record last verified: 2014-04

Locations

US (2)