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NCT02351544 · ClinicalTrials.gov registry record · NA
Prospective, Multi-Center Evaluation of the Efficacy of Peripheral Trigger Decompression Surgery for Migraine Headaches
A NA study, sponsored by Ohio State University.
- Completed
- Registry status
- NA
- Development phase
- 44
- Enrollment target
NCT02351544 is a NA study that has completed, run by Ohio State University. The registered enrollment target is 44 participants.
The verdict
NCT02351544, a NA study, has completed, sponsored by Ohio State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 44 participants
- Enrollment target
Study Summary
According to the peripheral trigger theory of migraine headaches, nociceptive inputs from irritated or compressed cranial nerve branches can lead to neurovascular changes in the brain that cause migraine headaches. Advanced treatments aimed at deactivating the peripheral trigger points can be administered to patients who have failed medical management of migraines. Those accepted advanced treatments include botulinum toxin A injection in order to temporarily paralyze muscles causing nerve compression, and surgery to release those compression points permanently. An advantage of surgery is the ability to release non-muscular causes of nerve compression, such as fascial bands or intersecting arteries. Botulinum toxin A injection into trigger sites has been shown in multiple studies to be effective at reducing the frequency and severity of migraine headaches, and is a very commonly administered treatment for refractory migraines. It is approved by the FDA for the treatment of chronic migraines. Similarly, surgical decompression of trigger sites has previously been shown to have superior clinical outcomes to medical management, through a randomized, blinded controlled-trial performed at Case Western Reserve in 2009. Patients either received actual decompression of the trigger sites, or sham surgery (exposure and visualization of the trigger sites, without decompression). At one-year follow-up, the group who underwent actual surgery demonstrated a statistically higher proportion with significant improvement in their migraines (83.7% vs. 57.7%, p=0.014), and with complete elimination of their migraines (57.1% vs. 3.8%, p\<0.001). Several other reports have confirmed the good clinical outcomes of surgery demonstrated in this trial, and surgical decompression is now commonly performed by several surgeons around the United States. Prognostic factors predicting the success of surgical decompression in migraine headache treatment include older age of migraine onset, visual s
Interventions
- PROCEDURE Surgery
- DRUG Botulinum Toxin Type A
- OTHER Daily headache diary
- OTHER Migraine Disability Assessment Test (MIDAS)
- OTHER Migraine Work and Productivity Loss Questionnaire (MWPLQ)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2015-09 |
| Est. Completion | 2022-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02351544
The ClinicalTrials.gov registry entry for NCT02351544 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Surgery is the first listed.
NCT02351544 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02351544 about?
NCT02351544 is a clinical study titled "Prospective, Multi-Center Evaluation of the Efficacy of Peripheral Trigger Decompression Surgery for Migraine Headaches". According to the peripheral trigger theory of migraine headaches, nociceptive inputs from irritated or compressed cranial nerve branches can lead to neurovascular changes in the brain that cause migraine headaches. Advanced treatments aimed at deactivating the peripheral trigger points can be admini...
What is the current status of trial NCT02351544?
This trial is currently completed. It is a NA study. The enrollment target is 44 participants. The study started on 2015-09. Estimated completion is 2022-06.
What interventions are being tested in trial NCT02351544?
The interventions under investigation include: Surgery (PROCEDURE), Botulinum Toxin Type A (DRUG), Daily headache diary (OTHER), Migraine Disability Assessment Test (MIDAS) (OTHER), Migraine Work and Productivity Loss Questionnaire (MWPLQ) (OTHER).
Who is sponsoring clinical trial NCT02351544?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
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