This trial is evaluating whether Treatment will improve 1 primary outcome and 13 secondary outcomes in patients with Sick Headache. Measurement will happen over the course of Week 12 of the double-blind treatment phase..
This trial requires 2900 total participants across 4 different treatment groups
This trial involves 4 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 in Phase 2 & 3 and have had some early promising results.
There is significant variation among states in patient encounters reported as having sick headache. These data highlight an important area for further refinement of clinical practice standards for headache disorders.
Common headache syndromes that occur frequently in the emergency department include headache originating from the head and neck, headache of unknown origin, and headache attributed to other causes including migraine and tension headache. Physicians must be aware of the potential for head pain to have many different causes in the acute setting and when evaluating patients with headache must consider whether their presentation is acute or chronic and whether it is episodic.
The data of the present study demonstrated the improvement of both the somatoform symptom and symptom-specific quality of life in SWH, which is the first report on this topic.
Sudden exacerbation of sick headache is most often treated with symptomatic medications at first. Treatment may be prolonged in case of medication non-response, or additional medication might be tried again. In some cases, a second medication might be used.
Most patients with sick headache use a number of medications, indicating that it is a multifactorial pain. Some of these medications cause CNS effects; these effects may be mediated through vasoconstriction of the cerebrovasculature. The presence of headache in the context of multiple medications may be indicative of a CNS issue.
There is no doubt in the literature that pain in the neck is a very significant presenting complaint of headache. The pain must be of high severity in order to be diagnosed as serious headache. The headache must not be relieved by medications prescribed without a prescription. This is to ensure that the patient does not take the medication for relief while the headache persists. The headache must be reported to healthcare professionals as this has a very high chance of becoming a life changing disease.
Although patients with headaches often seek healthcare for their headache symptoms, many also are seeking help for other associated conditions. The high rate of associated diagnoses was due to the lack of headache specialists. This finding suggests that patients with non-specific headache should consider clinical trials. Because these patients do meet the study criteria, a limited number of patients may choose these trials.
Treatment of sick headache does not improve HRQOL. HRQOL at baseline was most closely associated with HRQOL at 1 year, suggesting that HRQOL should be assessed at baseline and during therapy periods to ensure long-term improvement.
Older patients (≥50 years) are more likely than younger patients (20-39 years) to perceive that their headaches are aggravated by physical activity or other causes, headache severity decreases with age, and more than one-third of older subjects had a history of a headache-related concussion. As the study population only included healthy adults, the applicability of the results to the wider population should be carefully considered.
The new treatments and drug development technologies in treatment of sick headache have demonstrated significant improvement to the efficacy and safety profile of existing treatment options.
The primary cause of sick headache is not clear. To facilitate discussions about possible causes amongst pediatricians and their patients, we have suggested that we incorporate the question into routine outpatient consultations and referrals to specialists. This might improve treatment options for children with sick headache and reduce unnecessary diagnostic investigations.
There are several common types of headache that can be treated, or do not need treatment. Most headaches are not currently being addressed in treatments (at least among those seen by pediatricians, GPs, and internists), though some treatments such as migraines and cluster headaches may be addressed either partially or entirely.