Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Walter Reed Army Medical Center | FED |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Epidural Steroids | Experimental | A series of up to 3 epidural steroid injections (ESI)with depo-methylprednisolone |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| numerical rating scale (NRS) arm pain scores | arm pain on a 0-10 scale | 1 month after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| NRS Arm pain | 0-10 scale | 3 months |
| NRS arm pain | 0-10 scale | 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307 | United States | ||
| Johns Hopkins Medical Institutions |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18204398 | Background | 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. | |
| 18204388 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011843 | Radiculopathy |
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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) |
|
| NRS neck pain |
0-10 scale |
| 1- month |
| NRS neck pain | 0-10 scale | 3 months |
| NRS neck pain | 0-10 scale | 6 months |
| medication reduction | Cessation of non-opioid analgesic and/ or > 20% decrease in opioid consumption | 1-6 months |
| Global perceived effect | categorical variable assessing "satisfaction" with treatment | 1-6 months |
| Baltimore |
| Maryland |
| 21205 |
| United States |
| 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. |
| 18204386 | 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. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |