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COMPLETED NA

Conservative Therapy Versus Epidural Steroids for Cervical Radiculopathy

NCT01144923 · View on ClinicalTrials.gov ↗

Study Summary

The main objective of this study is to determine whether interventional treatment (i.e. epidural steroids), conservative therapy, or the combination, is superior for cervical radiculopathy. One hundred and sixty eight patients with radicular neck pain will be randomized in a 1:1:1 ratio to receive either cervical epidural steroid injections (CESI), non-interventional management with physical therapy and medications, or a combination of the two. The first follow-up visit will be at 1-month. In patients who obtain some benefit but continue to report significant pain, either a 2nd CESI can be done, the patient's medications can be adjusted, or both in the combination group. Those patients who fail to obtain any benefit will exit the study to receive another treatment or alternative care. The second follow-up visit will be at 3-months. Similar to the 1-month follow-up, the doctor may elect to change nothing in patients who are satisfied, adjust medications, schedule the patient for another CESI, or do both in the combination group. Patients who fail to obtain any benefit can exit the study to receive alternative treatment. The final follow-up visit will be at 6 months.

Conditions Studied

Interventions

  • OTHER Gabapentin and/or Nortriptyline, Physical therapy
  • PROCEDURE Epidural Steroid Injections (ESI)
  • OTHER Combination treatment

Study Locations (2)

District of Columbia

  • Walter Reed Army Medical Center — Washington D.C.

Maryland

  • Johns Hopkins Medical Institutions — Baltimore

Trial Details

FieldValue
Enrollment Target 169 participants
Start Date 2010-06
Est. Completion 2013-11
Phase NA

Sponsor

Johns Hopkins University

1,517 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01144923

The ClinicalTrials.gov registry entry for NCT01144923 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 169 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,517 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Cervical Radiculopathy appearing as the primary indexed condition, and to 3 interventions — of which Gabapentin and/or Nortriptyline, Physical therapy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01144923 reports 2 study locations spanning 2 distinct geographic areas — top geographies include District of Columbia, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01144923 about?

NCT01144923 is a clinical study titled "Conservative Therapy Versus Epidural Steroids for Cervical Radiculopathy". The main objective of this study is to determine whether interventional treatment (i.e. epidural steroids), conservative therapy, or the combination, is superior for cervical radiculopathy. One hundred and sixty eight patients with radicular neck pain will be randomized in a 1:1:1 ratio to receive e...

What is the current status of trial NCT01144923?

This trial is currently completed. It is a NA study. The enrollment target is 169 participants. The study started on 2010-06. Estimated completion is 2013-11.

What conditions does trial NCT01144923 study?

This clinical trial studies the following conditions: Cervical Radiculopathy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01144923?

The interventions under investigation include: Gabapentin and/or Nortriptyline, Physical therapy (OTHER), Epidural Steroid Injections (ESI) (PROCEDURE), Combination treatment (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01144923?

This trial is sponsored by Johns Hopkins University, which has 1,517 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01144923 being conducted?

This trial has 2 study locations across District of Columbia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial