Conservative Therapy Versus Epidural Steroids for Cervical Radiculopathy

NCT ID: NCT01144923

Last Updated: 2014-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 169 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2013-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

Gabapentin and/or Nortriptyline, Physical therapy

Intervention Type: 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 Steroids

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

Group Type: EXPERIMENTAL

Epidural Steroid Injections (ESI)

Intervention Type: PROCEDURE

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

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)

Group Type: EXPERIMENTAL

Combination treatment

Intervention Type: 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)

Interventions

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)

Intervention Type: OTHER

Epidural Steroid Injections (ESI)

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

Intervention Type: PROCEDURE

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)

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Walter Reed Army Medical Center

FED

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Steven P. Cohen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven P Cohen, MD

Role: STUDY_DIRECTOR

Johns Hopkins University

Salim Hayek, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Case Western

Rick Fisher, MD

Role: PRINCIPAL_INVESTIGATOR

Walter Reed National Military Medical Center

Locations

Walter Reed Army Medical Center

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

Johns Hopkins Medical Institutions

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 18204398 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18204388 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18204386 (View on PubMed)

Other Identifiers

NA_00036062

Identifier Type: -

Identifier Source: org_study_id