Efficacy and safety of acupuncture for chronic pain caused by tension-type headache: a multi-centre randomised controlled clinical trial

INTERVENTION: Chronic pain sufferers (tension‐type headache) are randomly allocated to one of the three treatment groups (verum acupuncture, sham acupuncture, or established standard therapy = amitriptyline). CONDITION: Tension‐type headache ; Signs and Symptoms ; Other headache syndromes PRIMARY OUTCOME: The binary endpoint is success, yes or no, 6 months after randomization. Success is defined as a reduction of the number of headache days per month of more than 50% in comparison with the number per month at baseline. SECONDARY OUTCOME: Pain intensity, von Korff Score, health‐related quality of life (12‐Item Short‐Form Health Survey SF‐12), Global Patient Assessment, number of adverse and severe adverse events, quality parameters e.g. the assessment of patients blindness to the mode of acupuncture (by asking the patient to guess their group assignment after the last follow up) INCLUSION CRITERIA: Signed informed consent, aged 18‐65, diagnosis of tension‐type headache according to the criteria of the International Headache Society, tension‐type headaches for >6 months, at least 10 headache days per month during the last 4 weeks before randomization (completed baseline headache diary), each day is rated as a headache day if headaches persisted for at least 4 hours or if the administration of analgesics is necessary to attenuate the pain, von Korff Chronic Pain Score at least Grade I, ability to speak and read German (to understand the questionnaires and telephone interviews).