Non-organic Signs to Predict Outcomes for Neck Pain
Completed
Conditions studied: Cervical Radiculopathy, Cervical Radicular Pain
In brief
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.
Key facts
- Study ID
- NCT04320836
- Run by
- Johns Hopkins University
- People needed
- 78
- Starts
- 2020-06-15
- Expected to finish
- 2022-03-30
- Last updated by the study team
- 2022-06-10
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age > 18
- Cervical radicular pain based on history and physical exam (e.g. pain radiating into one or both extremities, sensory loss, muscle weakness, Spurling's test etc.)
- Pain duration > 6 weeks
- Average NRS arm pain score > 4
- MRI evidence of disc pathology consistent with symptoms
You may not qualify if…
- Untreated coagulopathy
- Previous spine surgery
- No MRI study
- Epidural steroid injection within past 3 years
- Radiculopathy resulting from tumor or herpes zoster
- Signs or symptoms or myelopathy or spinal cord compression
- Allergic reactions to contrast allergy including macrocyclic gadolinium or depo-methylprednisolone
- Referrals from surgery for diagnostic injections for surgical evaluation
- Serious medical (e.g. congestive heart failure) condition that might preclude optimal outcome
- Pregnancy
Where it is running
- DC VA Medical Center — Washington D.C., District of Columbia, United States
- Johns Hopkins — Baltimore, Maryland, United States
- Seoul National University — Seoul, South Korea
Full record on ClinicalTrials.gov
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