Following previous evaluation from 1 January 2007 to 30 June 2007, where a total of 274 patients were screened and 217 were included [7 (
link)], we screened further 849 consecutive outpatients, who came for the first time at the Neurophysiopathology of Pain Unit (Neurological and Psychiatric Sciences Department, Bari University) from 1 July 2007 to 30 December 2009. The Neurophysiopathology of Pain Unit is a tertiary referral centre where patients are referred by primary physicians as well as by neurological and other specialty clinics. All participants gave written informed consent after receiving a detailed explanation of the purpose and design of the study. The study was approved by the local Ethics Committee of the Policlinico General Hospital.
According to the previous study [7 (
link)], during the first visit, all subjects had a standardized interview and underwent clinical neurological and psychiatric examination. The inclusion criteria was a diagnosis of primary headache made by three neurologists with special experience in headache, according to the International Classification of Headache Disorders, 2nd edn (ICHD-II) criteria [12 (
link)], and was supported by a 3-month observation time with a headache diary and allodynia questionnaire.
The inclusion/exclusion criteria and clinical management of patients were the same as the previous study [7 (
link)]. Briefly, patients with general medical, neurological or psychiatric diseases [13 ], were excluded from the study, as well as the patients on central nervous system-active drug therapy to rule out any drug effect on diffuse pain. A particular attention was taken in screening out patients suffering from various conditions with diffuse pain, such as arthritis, diabetes or other metabolic causes of neuropathic pain. We included other types of primary headaches, and in the case of hemicrania continua (code. 4.7) [12 (
link)], the 3 months preceding the first visit were considered for headache features and FM comorbidity, to prescribe indomethacine and confirm the diagnosis in the next control.
During the follow-up visit (except for patients with hemicrania continua, who were examined during their first visit, and the diagnosis confirmed at the follow-up), all patients underwent the clinical assessment, defined in the previous study [7 (
link)], consisting of evaluation for FM diagnosis and tender point count [1 (
link)], frequency of headache [7 (
link)], total tenderness score (TTS) [14 (
link)], allodynia questionnaire [15 (
link), 16 (
link)], Short-Form 36 (SF-36) Health Survey [17 ], depression [self-rating depression scale (SDS)] and anxiety [self-rating anxiety scale (SAS)] scales [18 (
link), 19 ], Multidimensional Assessment of Fatigue (MAF) [20 (
link)], and Medical Outcomes Study (MOS) [21 ]. In this study, we considered the sleep problems index (SLP9), expressing the sleep problems index, and Sleep quantity (SLPQ), expressing the sleep quantity [21 ].
Migraine Disability Assessment scale (MIDAS) [22 (
link)], in the Italian version [23 (
link)], was used to quantify headache-related disability in all headache patients, differently from the preliminary study [7 (
link)]; the MIDAS score was considered only for migraine groups.
Patients presenting with FM comorbidity, according to the ACR criteria [1 (
link)], were submitted for the Manual Tender Point Survey, [24 (
link)–26 (
link)] and answered the FM Impact Questionnaire (FIQ) [27 (
link)], in accord with the previous study [7 (
link)].
de Tommaso M., Federici A., Serpino C., Vecchio E., Franco G., Sardaro M., Delussi M, & Livrea P. (2011). Clinical features of headache patients with fibromyalgia comorbidity. The Journal of Headache and Pain, 12(6), 629-638.