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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: Clinical Trial Phase 3 study, sponsored by Boston Children's Hospital.
NCT03007420 is a Phase 3 study that was terminated before completion, run by Boston Children's Hospital. The registered enrollment target is 16 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Pain intensity was rated using the Numerical Rating Scale (NRS) of 0 to 10, with 0 indicating 'no pain' and 10 indicating the 'worst pain imaginable'.
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 |
Why NCT03007420 stopped before completion
NCT03007420 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03007420's enrollment target sits among peer trials
16 1974th of 2000 higher than 24 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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