Implementation and efficacy testing of acupuncture and exercise therapy in patients with frequent episodic and chronic tension-type headache on pain perception and quality of life: A pilot / feasibility study

Not Applicable

• Conditions: G44.2; Tension-type headache

• Registration Number: DRKS00016723
• Lead Sponsor: Tasly Healthcare Deutschland GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-11
• Study Completion: 2019-12-04
• Results First Posted: 2021-02-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 96

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

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).

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)