CLINICAL TRIAL

Dexamethasone for Cervicogenic Headache

Recruiting · 18+ · All Sexes · Bronx, NY

This study is evaluating whether a combination of medications may help reduce the severity of headaches following a traumatic brain injury.

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About the trial for Cervicogenic Headache

Eligible Conditions
Headache · Post-Traumatic Headache

Treatment Groups

This trial involves 2 different treatments. Dexamethasone is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Metoclopramide 10mg
DRUG
Dexamethasone
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Metoclopramide 10mg
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metoclopramide
FDA approved
Dexamethasone
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
and is not clearly due to the direct effects of a substance or its withdrawal Symptoms that cannot be attributed to another condition and are likely due to a person's environment or lifestyle are classified as headache. show original
If the headache is moderate or severe in intensity, it must be rated. show original
Traumatic injury to the head has occurred
Injury to the head has caused the development of a headache within 7 days. show original
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 48 hours and 7 days after emergency department discharge
Screening: ~3 weeks
Treatment: Varies
Reporting: 48 hours and 7 days after emergency department discharge
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 48 hours and 7 days after emergency department discharge.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Dexamethasone will improve 1 primary outcome and 2 secondary outcomes in patients with Cervicogenic Headache. Measurement will happen over the course of 48 hours.

Sustained headache relief
48 HOURS
Achieving a headache intensity of mild or none in the emergency department without use of rescue medication and maintaining that level for 48 hours without use of rescue medication.
48 HOURS
Moderate or Severe headache after Emergency Department discharge
48 HOURS
Rating headache moderate or severe on a scale of severe, moderate, mild, or none
48 HOURS
Post concussive symptom scale
48 HOURS AND 7 DAYS AFTER EMERGENCY DEPARTMENT DISCHARGE
The Sport Concussion Assessment Tool (SCAT) Post Concussion Symptom Scale (PCSS). On this validated instrument, patients rate 22 concussive symptoms on a 0 to 6 scale, with 6 signifying more severe pain
48 HOURS AND 7 DAYS AFTER EMERGENCY DEPARTMENT DISCHARGE

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can cervicogenic headache be cured?

Can cervicogenic headache be treated with high doses of oxycodone in conjunction with a medication-reflex preparation and/or physiotherapy? answer: Results are encouraging with oxycodone at the doses utilized. Further investigation is necessary to further define treatment protocols.

Anonymous Patient Answer

What is cervicogenic headache?

The cervicogenic headache syndrome results from compression and irritation of the cervical spinal canal and craniofacial nerves in a pattern similar to radiculopathy, with pain, paresthesia, weakness, and autonomic instability.

Anonymous Patient Answer

What are common treatments for cervicogenic headache?

Patients with cervicogenic headache often have recurrent debilitating episodes of headache. Treatment is determined by the treating clinician but may include medications including acetaminophen, ibuprofen, or naproxen. The efficacy of analgesic medications for this condition is not clear. Lignocaine topical patches may be used for the first few weeks after onset of symptoms, but are only recommended by those clinicians familiar with their application. Steroid medications are commonly used in those patients with refractory symptoms. The prognosis of cervicogenic headache is generally good, although the frequency of attacks in individuals with cervicogenic headache is reduced.

Anonymous Patient Answer

What causes cervicogenic headache?

Cervicogenic headache can be caused or worsened by the cervical spine. In contrast to other types of headache, cervicogenic headache can be triggered or precipitated by specific events.

Anonymous Patient Answer

How many people get cervicogenic headache a year in the United States?

There is a high proportion of persons who have received a CCH diagnosis and need to be appropriately treated in the United States. It remains, therefore, relevant to study the demographics of persons who have received a CCH diagnosis and to explore factors contributing to these disorders being unrecognized with their initial clinical presentation.

Anonymous Patient Answer

What are the signs of cervicogenic headache?

Cervical dicraffery and/or degeneration of the transverse ligaments of the spine are the most important causes of a chronic headache. The cervical spine is the site of origin of much of migraine and tension-type headache. Cervical pain is also a common presenting symptom of C-1 spondylosis.

Anonymous Patient Answer

Have there been other clinical trials involving dexamethasone?

There have been several clinical trials involving the use of steroids in the treatment of cervical root compression with positive results. However, the evidence to support the use of steroids in patients with cervical root compression remains undefined. No clinical trials have been conducted using dexamethasone therapy. It is our intention that this study be the first of its kind to test the use of systemic therapy against conservative treatment in patients with cervicogenic headache.

Anonymous Patient Answer

Is dexamethasone safe for people?

Dexamethasone is safe in a subset of people with cervicogenic headache who receive a non-opioid treatment (e.g., NSAIDs or gatifloxacin, [<ref>Bruyère et al. 2006; Am J Phys Med Rehabil 82: 1414-1418; Haldeman et al. 2006; Arch Phys Med Rehabil 86: 714-715; Haldeman et al. 2005; Arch Phys Med Rehabil 84: 713-714; Haldeman et al. 2003; Am J Phys Med Rehabil 80: 1331-1336; <ref>NINDS-RCT2005013829</ref> ).

Anonymous Patient Answer

Have there been any new discoveries for treating cervicogenic headache?

Treatment for cervicogenic headache has not changed in the past 20 years. Cervicogenic headache is uncommon but can be devastating, and so treatment is certainly needed. There is still no evidence-based management. Randomized controlled trials to determine the effectiveness of new treatments are urgently needed.

Anonymous Patient Answer

Who should consider clinical trials for cervicogenic headache?

Patients with a recent neck radiography report a higher prevalence of cervicogenic headache than patients without cervical radiographs. Younger females have a significantly higher prevalence of cervicogenic headache than older females. Clinical trials examining the effect of interventions on cervicogenic headache may include patients with or without a recent neck radiography report.

Anonymous Patient Answer

Does cervicogenic headache run in families?

We conclude that a diagnosis of cervicogenic headache was not more likely in families with a history of cervicogenic headache but was more likely in families with a history that included other headaches.

Anonymous Patient Answer

What are the common side effects of dexamethasone?

Most common side effects include hypotension, transient hypotension that spontaneously disappears by day 3. Hypotension is often due to dexamethasone-induced activation of adrenergic receptors due to the depletion of glucocorticoids. Dexamethasone was significantly associated with hypertension as well as transient hypotension on day 1, 2, and 3. Hypo-osmotic dehydration, a rare side effect from dexamethasone-induced depletion of osmotic agents, is a potential long-term complication.

Anonymous Patient Answer
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