This trial is evaluating whether Treatment will improve 3 primary outcomes, 6 secondary outcomes, and 6 other outcomes in patients with Sick Headache. Measurement will happen over the course of 2 hours post treatment at follow up phase.
This trial requires 300 total participants across 2 different treatment groups
This trial involves 2 different treatments. Treatment 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 not being studied for commercial purposes.
Many sick headache patients are able to control their symptoms with an appropriate medication regimen. This has positive implications for the self-management of chronic pain, including sick headache.
Most (about 70%) adults with sick headache will have a headache at some time during the year. Most people (60%) would take either medication that can help with the headache (drugs and nonpharmacological treatments); the others (about 40%) would not use any type of medication. Among those who use medication, about half (about 50%) would try it a lot, about 20% would read the package insert, and about 40% would try it once they had taken the first dose.
Sick headache occurs because the brain's pain centers have dysfunctional pain processing. However, the cause is not always clearly identified. It is common at episodic intervals with a mild to moderate intensity. There may be an increased chance of sick headache following exposure to viral, bacterial, or parasitic agents. Sick headache may have a psychological component; some individuals suffering sick headache report low coping abilities.
This patient's course is probably due to an acute infection or a neoplasm. Her initial presentation is highly suggestive of meningitis, but an alternative cause of headache should also be considered, such as infection or sinusitis.
Sick headache is an intense, episodic headache syndrome characterized by severity, duration, relief, impact on activities and disability. It is one of the most common chronic headache syndromes, affecting 2-3% of the US population. Different groups are more likely to have chronic, debilitating headache conditions such as sick headache. However, the majority of individuals with sick headache will experience significant improvements in their symptoms following treatment. Sick headache can have a variety of causes. Identification of the cause of a chronic headache such as sick headache is key to determining its etiology and therapeutic options.
In total, 8.6 million Americans are treated for episodic or persistent sick headache a year. In the United Kingdom, 8.8 million people have episodic or persistent sick headache a year. The number of people with episodic, persistent, or chronic sick headache per physician in the United States was 4.5 times higher than in the United Kingdom. This difference is likely related to the higher degree of access to medical practitioners and resources in the United States than in the United Kingdom.
In a recent study, findings suggests that there might be a genetic basis for sick headache, but further studies with larger sample sizes are required.
A combination of different treatments is used in less than 10% of patients with chronic migraine. However, this was reported by only 2% of individuals in this study.
To avoid duplicate investment in clinical trials, potential trial developers need to communicate with investors regarding whether the trial is part of a clinical series or a separate initiative. Such communication reduces the likelihood of the trial being seen as redundant, and may lead investors to be more willing to invest because they perceive the results will not be wasted.
There is evidence to show that a shortcourse of a standard medication (paracetamol) can induce a significant reduction of sick headaches. Results from a recent paper is the first study reporting these results using a short course of aspirin or paracetamol. Paracetamol could also be used for shortcourse treatment of migraine or tension headaches and may be used in the prophylactic treatment of recurrent headache attacks. More research could be required to show better evidence. Paracetamol could be used for shortcourse treatment of sick headache of unclear or unknown origin. Paracetamol could be used for shortcourse correction of sick headache in teenagers.
For many side effects, no clear differences were found regarding the presence or absence of a side effect or between the different groups. However, our data indicates that there are small differences.
Median age at onset is 27.6 years. Most (93.9 %) patients are younger than 50 years old. Female patients were somewhat older and more likely to have multiple bouts of headache over the last three months.