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| Name | Class |
|---|---|
| Washington DC VA Medical Center | UNKNOWN |
| Seoul National University | OTHER |
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Neck pain is the 4th leading cause of disability in the world, with approximately 50% being neuropathic in nature. Epidural steroid injections (ESI) are one of the most commonly used treatments for cervical radiculopathy. Physical exam signs, including non-organic signs, have been shown to predict outcomes for low back pain treatments, but have yet to be adequately studied for neck pain.
In this prospective, observational study, 72 patients with cervical radiculopathy undergoing an initial ESI for this pain episode will undergo a comprehensive history and physical examination that includes the presence of Spurling test, midline and paraspinal tenderness, 9 non-organic tests in 5 categories, and 3 questionnaires to assess depression, anxiety, sleep, and somatization. The investigators will also evaluate patients' MRI results to determine patients' precise pathology. Patients will then receive interlaminar cervical ESI. The primary outcome measure will be the difference in the proportion of people with a positive categorical outcome, defined as a >/= 2-point decrease in arm pain 4 weeks post-procedure coupled with a score >/= 5 on a 7-point patient global impression of change (PGIC) scale 4 weeks post-treatment, indicating subjective improvement.
The main objectives of this study are to:
Seventy-two patients with cervical radiculopathy undergoing an initial ESI for this pain episode will undergo a comprehensive history and physical examination that includes the presence of Spurling test, midline and paraspinal tenderness, 9 non-organic tests in 5 categories, and 3 questionnaires to assess depression, anxiety, sleep, and somatization.
Non-organic signs that the investigators will evaluate are:
Tenderness
Sham stimulation
Distraction
a. Inability to rotate head > 45 degrees during overt range-of-motion testing, but significantly greater range of motion when patient is lying prone and asked to turn head to respond to physician request (e.g. sign paper, count fingers, answer question).
Regional disturbances
Overreaction
The investigators will evaluate MRI results to determine the precise pathology. Patients will then receive interlaminar cervical ESI. In accordance with standard practice, a Tuohy needle will be directed towards the side of the radicular pain, with correct needle position in the epidural space being confirmed with real-time contrast injection. Once the physician is satisfied with the spread, a 3 mL solution consisting of depo-methylprednisolone 40 mg + 2 mL normal saline will be injected. At Seoul National University, due to Korean healthcare regulations, the mixture will be a 3 mL solution containing 10 mg of dexamethasone and 2 mL saline. The primary outcome measure will be the difference in the proportion of people with a positive categorical outcome, defined as a >/= 2-point decrease in average arm pain 4 weeks post-procedure coupled with a score >/= 5 on a 7-point patient global impression of change (PGIC) scale 4 weeks post-treatment, indicating subjective improvement. Secondary outcome measures will include mean reductions in average and worst 0-10 numerical rating scale (NRS) arm pain scores over the past 7 days, mean reduction in average and worst neck pain scores, neck disability index (NDI) score, medication usage, patient global impression of change (PGIC), Hospital Anxiety and Depression Scale (HADS), Athens Insomnia Scale (AIS), Somatic Symptom Scale-8 (SSS-8), and side effects. Individuals who experience a positive categorical outcome at 4 weeks will continue to be evaluated at 12 weeks, while those with a negative outcome will exit the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervical epidural steroid injection | This group will receive an interlaminar cervical ESI at C6-7 or C7-T1 with 1 mL steroid (depo-methylprednisolone 40 mg at Johns Hopkins and the DC VA Hospital or dexamethasone 10 mg at Seoul National University) and 2 mL normal saline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervical epidural steroid injection | Procedure | Interlaminar cervical epidural steroid injection with steroid and normal saline at C6-7 and C7-T1 (standard of care). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Categorical response | Positive response is defined as a >/= 2-point reduction in average arm pain coupled with >/= 5/7 score on patient global impression of change. Anything else is a negative response. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Average arm pain | Average arm pain on 0-10 numerical rating scale. | 4 weeks |
| Worst arm pain | Worst arm pain on 0-10 numerical rating scale. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with clinical and MRI evidence of cervical radicular pain who are scheduled to undergo cervical epidural steroid injection
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| Name | Affiliation | Role |
|---|---|---|
| Steven P Cohen, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DC VA Medical Center | Washington D.C. | District of Columbia | 20422 | United States | ||
| Johns Hopkins |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12911018 | Background | Fishbain DA, Cole B, Cutler RB, Lewis J, Rosomoff HL, Rosomoff RS. A structured evidence-based review on the meaning of nonorganic physical signs: Waddell signs. Pain Med. 2003 Jun;4(2):141-81. doi: 10.1046/j.1526-4637.2003.03015.x. | |
| 6446157 | Background | Waddell G, McCulloch JA, Kummel E, Venner RM. Nonorganic physical signs in low-back pain. Spine (Phila Pa 1976). 1980 Mar-Apr;5(2):117-25. doi: 10.1097/00007632-198003000-00005. |
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Upon request
Up to 3 years after publication
Upon request, contingent on objectives
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| ID | Term |
|---|---|
| D011843 | Radiculopathy |
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| 4 weeks |
| Average neck pain | Average neck pain on 0-10 numerical rating scale. | 4 weeks |
| Worst neck pain | Worst neck pain on 0-10 numerical rating scale. | 4 weeks |
| Neck disability index (NDI) score | NDI Score on 0-10 numerical rating scale. | 4 weeks |
| Somatic Symptom Scale (SS-8) score | 8-question survey, out of 32 points measuring somatization. | 4 weeks |
| Athens Insomnia Scale (AIS) score | 8-question survey, out of 24 points measuring sleep quality. | 4 weeks |
| Hospital Anxiety and Depression Scale (HADS) | 14-question survey measuring anxiety and depression (each out of 21 points). | 4 weeks |
| Patient Global Impression of Change (PGIC) scale | 7-point Likert scale measuring patient-reported improvement. | 4 weeks |
| Patient Global Impression of Change (PGIC) scale | 7-point Likert scale measuring patient-reported improvement. | 12 weeks |
| Hospital Anxiety and Depression Scale (HADS) | 14-question survey measuring anxiety and depression (each out of 21 points). | 12 weeks |
| Athens Insomnia Scale (AIS) score | 8-question survey, out of 24 points measuring sleep quality. | 12 weeks |
| Somatic Symptom Scale (SS-8) score | 8-question survey, out of 32 points measuring somatization. | 12 weeks |
| Average arm pain | Average arm pain on 0-10 numerical rating scale. | 12 weeks |
| Worst arm pain | Worst arm pain on 0-10 numerical rating scale. | 12 weeks |
| Average neck pain | Average neck pain on 0-10 numerical rating scale. | 12 weeks |
| Worst neck pain | Worst neck pain on 0-10 numerical rating scale. | 12 weeks |
| Neck disability index (NDI) score | NDI Score on 0-10 numerical rating scale. | 12 weeks |
| Categorical response | Positive response is a >/= 2-point reduction in average arm pain coupled with >/= 5/7 score on patient. Anything else is a negative response. | 12 weeks |
| Baltimore |
| Maryland |
| 21205 |
| United States |
| Seoul National University | Seoul | South Korea |
| 24730436 | Background | Jorritsma W, Dijkstra PU, De Vries GE, Geertzen JH, Reneman MF. Physical dysfunction and nonorganic signs in patients with chronic neck pain: exploratory study into interobserver reliability and construct validity. J Orthop Sports Phys Ther. 2014 May;44(5):366-76. doi: 10.2519/jospt.2014.4715. Epub 2014 Apr 14. |
| 36803892 | Derived | Cohen SP, Doshi TL, Dolomisiewicz E, Reece DE, Zhao Z, Anderson-White M, Kasuke A, Wang EJ, Hsu A, Davis SA, Yoo Y, Pasquina PF, Moon JY. Nonorganic (Behavioral) Signs and Their Association With Epidural Corticosteroid Injection Treatment Outcomes and Psychiatric Comorbidity in Cervical Radiculopathy: A Multicenter Study. Mayo Clin Proc. 2023 Jun;98(6):868-882. doi: 10.1016/j.mayocp.2022.11.022. Epub 2023 Feb 15. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |