Manual therapy as a prophylactic treatment for migraine. A pragmatic RCT

INTERVENTION: Intervention The total treatment duration in both groups is 12 weeks. The manual therapy consists of a maximum of 9 treatments (30 minutes) during a period of 12 weeks with pain‐reducing techniques for the high cervical musculature (stretching), muscle strengthening exercises for the deep neck flexor muscles and mobilization of the cervical and thoracic spine. The GP will treat participants as usual, based on the recommendations of the practice guideline for headache of the Dutch College of General Practitioners [8]. Apart from lifestyle advice and reassurance, the GP will provide or change acute medication and may provide or alter prophylactic medication. The GP will evaluate the treatment in consecutive appointments. CONDITION: ; headache ; migraine 10019231 PRIMARY OUTCOME: The primary outcome of the study is the number of migraine days, administrated ; by the participant in a headache diary during the four weeks prior to the ; follow‐up assessments (Tfelt‐Hansen 2012). A migraine day is defined as a day ; with migraine characteristics according to the IHS classification ICDH III for ; longer than four hours, or a headache that resolves with the intake of triptans ; or ergotamine within two hours of intake.; INCLUSION CRITERIA: Migraine according to the IHS classification ICHD III (2013): repeated attacks of moderate to intense headache, usually unilateral, throbbing headache with nausea and/or vomiting, duration of the headache attack between 4 and 72 hours, two or more attacks per month. Increasing with physical activity such as climbing stairs. Photofobia or phonofobia. Tensiontype headache (TTH) ICHD III (2013) that can be distinguished by the participant. Migraine with aura symptoms such as neck pain and additional presence of vision changes , tingling or numbness in lips, face, or hand (onesided), one‐sided muscle weakness, or impaired speech. Migraine more than 1 year present and participants who are stable on prophylactic medication. Age: between 18 years 65 years Participant is able to fill in questionnaires (understand Dutch language) SECONDARY OUTCOME: All of the secondary outcome measures will be assessed at 12, 26 and 52 weeks ; follow‐up assessments. ; ; The secondary outcome measures are: ; 1. Number of migraine attacks per four weeks, administrated in a headache diary ; during the four weeks before follow‐up measurements (Tfelt‐Hansen 2012). ; Migraine attacks will be considered as separate attacks if 48 hours without ; headache is reported in the headache diary between migraine days. ; 2. Pain intensity of migraine, assessed on an 11 point numerical rating scale ; (0 = no pain, 10 = most severe pain) (Williamson 2005). ; 3. Neck pain intensity, assessed on an 11 point numerical rating scale (0 = ; no pain, 10 = most severe pain). ; 4. Medication use in number of doses per 4 weeks of simple analgesics (e.g., ; paracetamol), NSAIDs, acute migraine medication (triptans and ergotamines) or ; prophylactic medication. Change of medication will be administrated and ; reported. ; 5. Responder rate will be measured by the number of migraine days before vs. ; after treatment, dichotomized into *50% reduction or not (Tfelt‐Hansen 2012). ; 6. Disability, assessed by the HIT‐6 questionnaire. The HIT‐6 consists of 6 ; questions measuring pain intensity, social functioning, role functioning, ; vitality, cognitive functioning and psychological distress on a 5 point ordinal ; rating scale (never, to always). Internal consistency is considered high ; (Cronbach's alpha 0.82 to 0.90), and test‐retest reliability is fair (ICC 0.77) ; (Yang 2011). The Dutch version of the HIT‐6 questionnaire has shown to be a ; valid and reliable tool to measure the impact of migraine (Martin 2004). ; 7. The endurance of the neck flexor muscles will be scored as the number of ; seconds the participant can raise his head from the table when lying in supine ; position as described by Harris et al. (2005). ; 8. Cutaneous allodynia (CA) will be evaluated with the 12 item allodynia ; symptom checklist (ASC‐12). This questionnaire consists of 12 questions about ; cutaneous hypersensitivity in the cervical cephalic region. The participant can ; score yes, no, or not applicable (Jakubowski 2005). Allodynia symptoms and ; score on CA severity are defined in the following categories: none (0‐2), mild ; (3‐5), moderate (6‐8) and severe (9 or higher) (Lipton 2008). ; 9. We will perform algometry, by measuring pressure pain thresholds (PPT) with ; a Wagner FDK algometer at the upper trapezius muscle (at the midpoint between ; C7 spinosus and the acromion), the suboccipital muscles and the anterior tibial ; muscle. The PPT measurement will be repeated three times at each point, and a ; mean score will be calculated. ; 10. Participants will be asked to report global perceived effect on a 7 point ; rating scale (0 = much worse to 6 = much better). Disability due to attacks ; will be assessed on a 5 point rating scale (0 = no disability and no medication ; to 4 = fully disabled even with medication). Also, use of healthcare resources ; and absence of work will be reported. ; 11. Adverse events will be administrated for both treatments. ;