HDACU
Description
This data come from an observational, retrospective case-control study, according to the STROBE and STRICTA guides. The study was carried out in the Son Llàtzer University Hospital Pain Clinic of Palma de Mallorca, Spain. Ethical approval was obtained from the Balearic Islands Human Research Ethics Committee in January 2017 (CEI-IB, #IB 3341/16 PI). The local ethics review boards, and the study itself was conducted according to standard guidelines. The trial was registered with ClinicalTrials.gov, number NCT03250754. Data from patients with Headache Disorders (HDs), which did not respond to conventional treatment for at least 6 months, referred to the Pain Clinic, between January 2010 and December 2015, were retrospectively examined. To be included, patients had to meet the following criteria: clinical diagnosis of headache (> 12 months) and at least two headaches per month; age ≥ 18 years. Physicians classified patients according to the criteria of the International Headache Society to differentiate between patients with migraine, tension-type headache (TTH), trigeminal autonomic cephalgias (cluster headache and Horton's headache), trigeminal neuralgia (TN), occipital neuralgia, cervicogenic headache and post-surgery headache. The exclusion criteria for patients were headache caused by somatic diseases such as hypertension, meningioma or meningoencephalitis and onset of headache or acupuncture treatment less than 1-year before. Patients continued with routine care (new prophylactic drug treatment (PDT), treatment of acute headache attacks and lifestyle, meditation, exercise and dietary instructions) or, received acupuncture instead of PDT
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The following variables were recorded for each patient: age, gender, type of headache disorder (tension-type headache, trigeminal autonomic cephalgias (cluster headache and Horton's headache), trigeminal neuralgia, occipital neuralgia, cervicogenic headache and post-surgery headache), visual analogue scale (VAS) for pain, expectations, satisfaction, days with headache, sleep quality, acute medication use and adverse events of the treatment. The primary outcome was the number of days with headache, comparing the groups at baseline and at the end of the third month of treatment. Because the improvements observed were essentially proportional to the headache at study entry, we also calculated the percent reduction of headache days for each patient. Treatment responders were also calculated: a patient with a reduction of ≥ 50% was considered to be a treatment responder. Secondary outcome parameters included: VAS for pain, the patients were asked to estimate the average severity of the headaches experienced in the month prior to the visit using a scale from 0 to 10, with 10 representing “very severe pain” and 0 “no pain”. Satisfaction with treatment, they completed the VAS to rate their level of satisfaction, placing a mark on a 10-cm line that was marked on either end from “not satisfied at all” to “very satisfied.” Patient baseline and follow-up expectations, they were asked at baseline about “what are the expectations with the treatment?” using a scale from 0 to 10, with 10 representing “highest expectations” and 0 “without expectation”, and they were asked after 1 and 3 months: “Are the results of your treatment what you expected?” using a scale from 0 to 10, with 10 representing “expectations were fully fulfilled” and 0 “unfulfilled expectations”. Sleep quality, the patients were asked about the quality of the sleep, ranging from 10 (good quality) to 0 (poor quality). Acupuncture-associated AEs (perceived by patients and physicians) including bleeding, subcutaneous hemorrhage, hematoma, fainting, serious pain, and local infection, were recorded.