Combination of acupuncture and medical training therapy on tension type headache: Results of a randomised controlled pilot study

Joerg Schiller, Matthias Karst, Tim Kellner, Wen Zheng, Daniel Niederer, Lutz Vogt, Isabelle Eckhardt, Florian Beissner, Christoph Korallus, Christian Sturm, Christoph Egen, Christoph Gutenbrunner, Matthias Georg Fink, Joerg Schiller, Matthias Karst, Tim Kellner, Wen Zheng, Daniel Niederer, Lutz Vogt, Isabelle Eckhardt, Florian Beissner, Christoph Korallus, Christian Sturm, Christoph Egen, Christoph Gutenbrunner, Matthias Georg Fink

Abstract

Objectives: The aim of this study was to compare the effects of acupuncture and medical training therapy alone and in combination with those of usual care on the pain sensation of patients with frequent episodic and chronic tension-type headache.

Design: This was a prospective single-centre randomised controlled trial with four balanced treatment arms. The allocation was carried out by pre-generated randomisation lists in the ratio 1:1:1:1 with different permutation block sizes.

Setting: The study was undertaken in the outpatient clinic of Rehabilitation Medicine of the Hannover Medical School.Participants and interventions: Ninety-six adult patients with tension-type headache were included and randomised into usual care (n = 24), acupuncture (n = 24), medical training (n = 24), and combination of acupuncture and medical training (n = 24). One patient was excluded from analysis because of withdrawing her/his consent, leaving 95 patients for intention to treat analysis. Each therapy arm consisted of 6 weeks of treatment with 12 interventions. Follow-up was at 3 and 6 months.

Main outcome measures: Pain intensity (average, maximum and minimum), frequency of headache, responder rate (50% frequency reduction), duration of headache and use of headache medication.Clinical results: The combination of acupuncture and medical training therapy significantly reduced mean pain intensity compared to usual care (mean = -38%, standard deviation = 25%, p = 0.012). Comparable reductions were observed for maximal pain intensity (-25%, standard deviation = 20%, 0.014) and for minimal pain intensity (-35%, standard deviation = 31%, 0.03). In contrast, neither acupuncture nor medical training therapy differed significantly from usual care. No between-group differences were found in headache frequency, mean duration of headache episodes, and pain medication intake. At 3 months, the majority of all patients showed a reduction of at least 50% in headache frequency. At 6 months, significantly higher responder rates were found in all intervention groups compared to usual care.

Conclusions: In contrast to monotherapy, only the combination of acupuncture and medical training therapy was significantly superior in reduction of pain intensity compared to usual care.Trial registration: Registered on 11 February 2019. German Clinical Trials Register, DRKS00016723.

Keywords: Tension type headache; acupuncture; exercise therapy; medical training; traditional Chinese medicine.

Conflict of interest statement

Declaration of conflicting interests: The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Figures

Figure 1.
Figure 1.
CONSORT flowchart of the study. AP: acupuncture; MTT: medical training therapy; n: number; PT: physiotherapeutic; TCM: traditional Chinese medicine; UC: usual care.
Figure 2.
Figure 2.
Box plots of the pain intensity change scores (differences) from baseline to 3-month follow-up (T0–T3) and to 6-month follow-up (T0–T4, sustainability). The plots include individual data (dots), medians (horizontal lines), interquartile ranges and whisker bars (90 % intervals, vertical lines). The asterisks (*) indicate a significant group difference to the usual care group (refer to Table 5). int: intensity; max: maximal; n: number.
Figure 3.
Figure 3.
Box plots of the headache frequency, duration, and medication intake change scores (differences) from baseline to 3-month follow-up (T0–T3) and to 6-month follow-up (T0–T4, sustainability). The plots include individual data (dots), medians (horizontal lines), interquartile ranges and whisker bars (90 % intervals, vertical lines). freq: frequency; med: medication.

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