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Non-organic Signs to Predict Outcomes for Neck Pain

NCT04320836 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 78

Last updated 2022-06-10

No results posted yet for this 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.

Conditions

  • Cervical Radiculopathy
  • Cervical Radicular Pain

Interventions

PROCEDURE

Cervical epidural steroid injection

Interlaminar cervical epidural steroid injection with steroid and normal saline at C6-7 and C7-T1 (standard of care).

Sponsors & Collaborators

  • Washington DC VA Medical Center

    collaborator UNKNOWN

  • Seoul National University

    collaborator OTHER

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Steven P Cohen, MD · Johns Hopkins University

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-15
Primary Completion
2022-03-30
Completion
2022-03-30

Countries

  • United States
  • South Korea

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04320836 on ClinicalTrials.gov