Non-organic Signs to Predict Outcomes for Neck Pain
Public ClinicalTrials.gov record NCT04320836. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Prospective Study to Determine Evaluate the Validity and Predictive Ability of Physical Exam Signs for Cervical Radiculopathy to Predict Epidural Steroid Injection (ESI) Treatment Outcomes.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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: 1. Determine the ability of physical exam, including non-organic signs, to predict ESI outcomes in individuals with cervical radicular pain. 2. Determine the prevalence of different non-organic signs, and the association with other factors that may be associated with non-organic illness such as psychopathology and multiple unrelated pain conditions.
Study identification
- NCT ID
- NCT04320836
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 78 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 90 Years
- Sex
- All
- Healthy volunteers
- Not listed
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 14, 2020
- Primary completion
- Mar 29, 2022
- Completion
- Mar 29, 2022
- Last update posted
- Jun 9, 2022
2020 – 2022
United States locations
- U.S. sites
- 2
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| DC VA Medical Center | Washington D.C. | District of Columbia | 20422 | — |
| Johns Hopkins | Baltimore | Maryland | 21205 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04320836, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 9, 2022 · Synced Sep 12, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04320836 live on ClinicalTrials.gov.