Abstract
BackgroundThis study aims to evaluate the feasibility and efficacy of a complex health intervention, based on the combination of conventional Western medicine and traditional Chinese medicine (TCM), in an outpatient department of a university hospital for patients with frequent episodic or chronic tension-type headaches.Methods/designThis is a prospective randomized controlled pilot study with four balanced treatment arms (usual care, acupuncture, training, and training plus acupuncture). Each arm will have 24 patients. After the initial screening examination and randomization, a 6-week treatment period follows, with treatment frequencies decreasing at 2-week intervals. After completion of the intervention, two follow-up evaluations will be performed 3 and 6 months after the start of treatment. At predefined times, the various outcomes (pain intensity, health-related quality of life, pain duration, autonomic regulation, and heart rate variability) as well as the participants’ acceptance of the complex treatment will be evaluated with valid assessment instruments (Migraine Disability Assessment, PHQ-D, GAD-7, and SF-12) and a headache diary. The acupuncture treatment will be based on the rules of TCM, comprising a standardized combination of acupuncture points and additional points selected according to individual pain localization. The training therapy comprises a combination of strength training, endurance training, and training to improve flexibility and coordination. Besides descriptive analyses of the samples, their comparability will be assessed using an analysis of variance (ANOVA) or chi-squared tests. Analyses will be performed on an intention-to-treat basis. Potential interaction effects will be calculated using a repeated-measures ANOVA to test the primary and secondary hypotheses. In supplementary analyses, the proportion of treatment responders (those with a 50% reduction in the frequency of pain episodes) will be determined for each treatment arm.DiscussionThis trial may provide evidence for the additive effects of acupuncture and medical training therapy as a combination treatment and may scientifically support the implementation of this complex health intervention.Trial registrationRegistered on 11 Feburary 2019. German Clinical Trials Register, DRKS00016723.
Highlights
This study aims to evaluate the feasibility and efficacy of a complex health intervention, based on the combination of conventional Western medicine and traditional Chinese medicine (TCM), in an outpatient department of a university hospital for patients with frequent episodic or chronic tension-type headaches
Schiller et al Trials (2019) 20:623. Both acupuncture and medical training therapy (MTT) are used as monotherapies to treat tension-type headaches. The usefulness of both acupuncture and MTT as effective treatment options with moderate but clinically relevant effect sizes has been demonstrated in metaanalyses [1, 2]
The benefits of acupuncture treatment have been shown in studies comparing acupuncture with usual care [3, 4] and so-called sham acupuncture [5]
Summary
This study aims to evaluate the feasibility and efficacy of a complex health intervention, based on the combination of conventional Western medicine and traditional Chinese medicine (TCM), in an outpatient department of a university hospital for patients with frequent episodic or chronic tension-type headaches. Both acupuncture and medical training therapy (MTT) are used as monotherapies to treat tension-type headaches. Despite the evidence in support of the effectiveness of acupuncture and MTT, we could not identify any studies evaluating the efficacy of a combination of acupuncture and MTT for tension-type headaches in comparison with the two treatment modalities alone or with usual care
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