Clinical trial NCT01144923: Conservative Therapy Versus Epidural Steroids for Cervical Radiculopathy
Official title: Randomized, Comparative-effectiveness Study Comparing Epidural Steroid Injections to Conservative Management With Medications and Physical Therapy in Patients With Cervical Radiculopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Radiculopathy
Keywords: epidural steroid injection
neck pain
pharmacotherapy
radiculopathy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Walter Reed Army Medical Center
First posted: 2010-06-16
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: numerical rating scale (NRS) arm pain scores
timeFrame: 1 month after treatment
Secondary outcomes:
measure: NRS Arm pain
timeFrame: 3 months
measure: NRS arm pain
timeFrame: 6 months
measure: NRS neck pain
timeFrame: 1- month
measure: NRS neck pain
timeFrame: 3 months
measure: NRS neck pain
timeFrame: 6 months
measure: medication reduction
timeFrame: 1-6 months
measure: Global perceived effect
timeFrame: 1-6 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
city: Baltimore
country: United States
facility: Johns Hopkins Medical Institutions
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Steven P Cohen, MD
role: STUDY_DIRECTOR
affiliation: Case Western
name: Salim Hayek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Walter Reed National Military Medical Center
name: Rick Fisher, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.