Evidence map›Paper›PMID 31703750›Full record

ArticleTrials2019

The best from East and West? Acupuncture and medical training therapy as monotherapies or in combination for adult patients with episodic and chronic tension-type headache: study protocol for a randomized controlled trial.

J Schiller, T Kellner, J Briest, K Hoepner, A Woyciechowski, A Ostermann, C Korallus, C Sturm, T Weiberlenn, L Jiang and 6 more

Abstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

J SchillerDepartment of Rehabilitation Medicine, Hannover Medical School, Hannover, Carl-Neuberg-Straße 1, 30625, Germany. schiller.joerg@mh-hannover.de.
T KellnerDepartment of Rehabilitation Medicine, Hannover Medical School, Hannover, Carl-Neuberg-Straße 1, 30625, Germany.
J BriestDepartment of Rehabilitation Medicine, Hannover Medical School, Hannover, Carl-Neuberg-Straße 1, 30625, Germany.
K HoepnerDepartment of Rehabilitation Medicine, Hannover Medical School, Hannover, Carl-Neuberg-Straße 1, 30625, Germany.
A WoyciechowskiDepartment of Rehabilitation Medicine, Hannover Medical School, Hannover, Carl-Neuberg-Straße 1, 30625, Germany.
A OstermannDepartment of Rehabilitation Medicine, Hannover Medical School, Hannover, Carl-Neuberg-Straße 1, 30625, Germany.
C KorallusDepartment of Rehabilitation Medicine, Hannover Medical School, Hannover, Carl-Neuberg-Straße 1, 30625, Germany.
C SturmDepartment of Rehabilitation Medicine, Hannover Medical School, Hannover, Carl-Neuberg-Straße 1, 30625, Germany.
T WeiberlennMedical practice for Traditional Chinese Medicine, Hannover, Germany.
L JiangDepartment of Rehabilitation Medicine, Hannover Medical School, Hannover, Carl-Neuberg-Straße 1, 30625, Germany.
C EgenDepartment of Rehabilitation Medicine, Hannover Medical School, Hannover, Carl-Neuberg-Straße 1, 30625, Germany.
F BeissnerSomatosensory and Autonomic Therapy Research, Institute for Neuroradiology, Hannover Medical School, Hannover, Germany.
M StieschDepartment of Prosthetic Dentistry and Biomedical Materials Science, Hannover Medical School, Hannover, Germany.
M KarstDepartment of Rehabilitation Medicine, Hannover Medical School, Hannover, Carl-Neuberg-Straße 1, 30625, Germany.
C GutenbrunnerDepartment of Rehabilitation Medicine, Hannover Medical School, Hannover, Carl-Neuberg-Straße 1, 30625, Germany.
M G FinkDepartment of Rehabilitation Medicine, Hannover Medical School, Hannover, Carl-Neuberg-Straße 1, 30625, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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. DISCUSSION: This 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.

Indexed as

Acupuncture TherapyEndurance TrainingRandomized Controlled Trials as TopicResistance TrainingAdultCombined Modality TherapyHumansMedicine, Chinese TraditionalOutcome Assessment, Health CarePilot ProjectsProspective StudiesQuality of LifeTension-Type HeadacheAcupunctureChronic tension-type headacheEpisodic tension-type headacheExerciseMedical training therapyRandomized controlled trialStudy protocolTraditional Chinese Medicine

Identifiers

PMID31703750
PMCPMC6839056

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.