Conservative Therapy Versus Epidural Steroids for Cervical Radiculopathy

Cervical Radiculopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01144923
• Other study ID #: NA_00036062
• Status: Completed
• Phase: N/A
• First received: June 14, 2010
• Last updated: April 23, 2014
• Start date: June 2010
• Est. completion date: November 2013

Study information

• Verified date: April 2014
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Radiculopathy
• Radiculopathy

Intervention

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)

Locations

Country	Name	City	State
United States	Johns Hopkins Medical Institutions	Baltimore	Maryland
United States	Walter Reed Army Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Walter Reed Army Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

Carragee EJ, Hurwitz EL, Cheng I, Carroll LJ, Nordin M, Guzman J, Peloso P, Holm LW, Côté 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. Review. — View Citation

Hogg-Johnson S, van der Velde G, Carroll LJ, Holm LW, Cassidy JD, Guzman J, Côté 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. Review. — View Citation

Hurwitz EL, Carragee EJ, van der Velde G, Carroll LJ, Nordin M, Guzman J, Peloso PM, Holm LW, Côté 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	numerical rating scale (NRS) arm pain scores	arm pain on a 0-10 scale	1 month after treatment	No
Secondary	NRS Arm pain	0-10 scale	3 months	No
Secondary	NRS arm pain	0-10 scale	6 months	No
Secondary	NRS neck pain	0-10 scale	1- month	No
Secondary	NRS neck pain	0-10 scale	3 months	No
Secondary	NRS neck pain	0-10 scale	6 months	No
Secondary	medication reduction	Cessation of non-opioid analgesic and/ or > 20% decrease in opioid consumption	1-6 months	No
Secondary	Global perceived effect	categorical variable assessing "satisfaction" with treatment	1-6 months	No