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NCT03007420 · ClinicalTrials.gov registry record · Phase 3
A Prospective Controlled Treatment Trial for Post-Traumatic Headaches
A Phase 3 study, sponsored by Boston Children's Hospital.
- Terminated
- Registry status
- Phase 3
- Development phase
- 16
- Enrollment target
NCT03007420 is a Phase 3 study that was terminated before completion, run by Boston Children's Hospital. The registered enrollment target is 16 participants.
The verdict
NCT03007420, a Phase 3 study, was terminated before completion, sponsored by Boston Children's Hospital.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 16 participants
- Enrollment target
Study Summary
Post-traumatic headaches (PTH) are the most common complaint after traumatic brain injury, possibly generated by a number of stressors to the trigeminovascular and cervical plexus networks, including inflammation of the high cervical facet joints, traumatic cranial neuralgias, migraines, and myofascial injuries. To date, no treatment guidelines exist for PTH management except for conservative modalities, such as cognitive rest, physical therapy, and neuropathic pain medications, all of which have minimal evidence to support them. The investigators propose a randomized, controlled, clinical trial and prospective follow-up study to evaluate the effect of invasive procedures such as occipital nerve block (ONB) and cervical medial branch block (CMBB) in the management of PTH. Adolescents and adults (14-45 years of age) will be recruited from Boston Children's Hospital and Beth Israel Deaconess Medical Center Pain clinics, Concussion clinics and Headache clinics.
Interventions
- DRUG Occipital Nerve Block (ONB) using lidocaine and dexamethosone
- DRUG Cervical Medial Branch Block (CMBB) using lidocaine and dexamethosone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2018-01-02 |
| Est. Completion | 2024-06-14 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03007420
The ClinicalTrials.gov registry entry for NCT03007420 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Occipital Nerve Block (ONB) using lidocaine and dexamethosone is the first listed.
NCT03007420 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03007420 about?
NCT03007420 is a clinical study titled "A Prospective Controlled Treatment Trial for Post-Traumatic Headaches". Post-traumatic headaches (PTH) are the most common complaint after traumatic brain injury, possibly generated by a number of stressors to the trigeminovascular and cervical plexus networks, including inflammation of the high cervical facet joints, traumatic cranial neuralgias, migraines, and myofasc...
What is the current status of trial NCT03007420?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 16 participants. The study started on 2018-01-02. Estimated completion is 2024-06-14.
What interventions are being tested in trial NCT03007420?
The interventions under investigation include: Occipital Nerve Block (ONB) using lidocaine and dexamethosone (DRUG), Cervical Medial Branch Block (CMBB) using lidocaine and dexamethosone (DRUG).
Who is sponsoring clinical trial NCT03007420?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
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