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NCT04320836 · ClinicalTrials.gov registry record
Non-organic Signs to Predict Outcomes for Neck Pain
A clinical trial, sponsored by Johns Hopkins University.
- Completed
- Registry status
- 78
- Enrollment target
NCT04320836: Completed study, sponsored by Johns Hopkins University.
NCT04320836 is a clinical trial that has completed, run by Johns Hopkins University. The registered enrollment target is 78 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04320836 has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- 78 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- PROCEDURE Cervical epidural steroid injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2020-06-15 |
| Est. Completion | 2022-03-30 |
What the finished NCT04320836 record still lists
NCT04320836 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 78 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Cervical epidural steroid injection is the first listed.
NCT04320836 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04320836 about?
NCT04320836 is a clinical study titled "Non-organic Signs to Predict Outcomes for Neck Pain". 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 o...
What is the current status of trial NCT04320836?
This trial is currently completed. The enrollment target is 78 participants. The study started on 2020-06-15. Estimated completion is 2022-03-30.
What interventions are being tested in trial NCT04320836?
The interventions under investigation include: Cervical epidural steroid injection (PROCEDURE).
Who is sponsoring clinical trial NCT04320836?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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