G44.2
Conditions
Interventions
Group 1: Acupuncture
Group 2: Medical training therapy
Group 3: Combination of acupuncture and medical training therapy
Group 4: Usual care
Sponsors
Tasly Healthcare Deutschland GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patients aged between 18 and 65 years, suffering from frequent episodic or chronic tension-type headache for more than 6 months. According to these criteria, an episode of headache has to occur at least on one day per month for at least 3 months and the duration of the headache attack must be at least 30 minutes, but no longer than 7 days continuously. Furthermore, subjects have to be capable of fully completing the assessments used.
Exclusion criteria
Exclusion criteria: Patients participating at the time of, or having participated during the last 30 days prior to, the initial screening examination in another clinical trial or who have been treated with acupuncture or MTT for tension-type headache within the last 6 months prior to the initial examination will be excluded from the study. Furthermore, subjects who fulfil one of the following criteria will also be excluded: serious psychiatric disorder; substance dependence and/or misuse; use of headache medication on >10 days/month; severe neurological and/or severe medical diseases; pregnant women and nursing women (planned pregnancy during the study period); patients with migraine if attacks occur more frequently than once per year; unstable angina pectoris; NYHA III-IV heart failure; uncontrollable or untreatable arterial hypertension; other medical causes of headache (e.g. pseudotumor cerebri, sleep apnea syndrome, newly developed daily headache).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in mean pain intensity (numerical rating scale) before the start of the intervention (T1) compared with the pain intensity 6 weeks after the end of the intervention (T3) | — |
Secondary
| Measure | Time frame |
|---|---|
| One of the secondary endpoint is the frequency of pain episodes in days/month, from which, besides the rate of responders (at least 50% pain reduction), the frequency of occurrence can be calculated. Other secondary endpoints are episode duration of the headache attacks, consumption of pain medication for tension-type headache, health-related quality of life, effect of headache on fitness and functional impairments (activities and participation), information about psychological health (mood, drive, anxiety, etc.), as well as autonomic factors (sleep-wake rhythm). These outcomes will be measured using the MIDAS questionnaire, parts of the PHQ-D , PHQ-9 , GAD-7 questionnaires, and the SF-12 questionnaire. Since depressed mood and anxiety have a significant influence on pain experience and coping, a short written assessment of the fear of the treatment will be performed—besides the standardized assessments of anxiety and depression (T0-T4, PHQ-9; GAD-7)—to evaluate treatment expectations and mood , . After written and verbal instructions, the patients will independently complete the questionnaires. The completed questionnaires will then be passed on to the study nurse in a closed envelope with the study ID. The outcome parameters will be entered into a database by a member of the scientific staff, who is not involved in the treatment process, and then be reviewed by two of the principal investigators. Measuring individual psychological stress levels The effect of the interventions on individual psychological stress levels is determined by measuring treatment-related changes in heart rate variability. Furthermore, by measuring HRV during acupuncture, distinct types of response to the stimulus shall be explored and their potential influence on the efficacy of the treatment be evaluated. Clinical examination for temporomandibular dysfunction: Whether a patient suffers from TMD is determined using the RDC/TMD criteria. The Research Diagnostic Criteria for Tempo | — |
Countries
Germany
Contacts
Public ContactJoerg Schiller
Medizinische Hochschule Hannover
Outcome results
None listed