Tension-type headache Signs and Symptoms Other headache syndromes
Conditions
Interventions
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).
Sponsors
Ruhr-University Bochum (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
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).
Exclusion criteria
Exclusion criteria: Additional migraines for more than 1 day per month, secondary headaches, additional chronic pain as a result of other additional diseases, prophylaxis of headaches with drugs during the last 12 months, modification of a permanent analgesic therapy, or a new cortison-therapy within the last 8 weeks before randomization, abuse of drugs or pain medication, any acupuncture treatment against tension-type headaches at any time, or previous treatment with needle-acupuncture in any other indication in the last year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Germany
Outcome results
None listed