Benefits and risks

Information for the public

When NICE looked at the evidence, it decided that there was not enough evidence about how well the procedure works. The 5 studies that NICE looked at involved a total of 214 patients.

Generally, they showed the following benefits of using the device over 1–2 months compared with the standard treatment for cluster headache:

fewer headache attacks
complete pain relief in some patients, within minutes of using the device
other headache treatments were needed on fewer occasions
improved quality of life.

Generally, they showed the following benefits of using the device for migraine:

pain relief in about half of patients, and complete pain relief in about 20% of patients, within 2 hours of using the device
relief of sickness, sensitivity to light and noise in about 30–50% of patients
recovery from disability caused by migraine in about 30% of patients within 2 hours of using the device
other migraine treatment was needed in just over half of patients 2 hours after using the device.

There were no serious risks associated with using the device. The studies included reports of the device causing headaches, dizziness, neck stiffness, pain in the mouth and throat, shoulder pain, palpitations, muscle spasm, mild lip or facial drooping, temporary mild confusion and reddening of the skin around the treatment site in a small number of patients.

NICE was also told about some other possible risks: shortness of breath and changes in blood pressure.

If you want to know more about the studies, see the guidance. Ask your health professional to explain anything you don't understand.