Department of Rehabilitation Medicine, Hannover Medical School, Hannover, Carl-Neuberg-Straße 1, 30625, Germany.
Medical practice for Traditional Chinese Medicine, Hannover, Germany.
Trials. 2019 Nov 8;20(1):623. doi: 10.1186/s13063-019-3700-1.
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.
METHODS/DESIGN: This 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.
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.
Registered on 11 Feburary 2019. German Clinical Trials Register, DRKS00016723.
本研究旨在评估一种基于中西医结合的复杂健康干预措施在大学医院门诊治疗频繁发作或慢性紧张型头痛患者的可行性和疗效。
方法/设计：这是一项前瞻性随机对照初步研究，共分为四个平衡治疗组（常规护理、针灸、训练和训练加针灸），每组 24 例患者。在初始筛选检查和随机分组后，进行为期 6 周的治疗期，治疗频率每两周递减一次。干预结束后，将在治疗开始后 3 个月和 6 个月进行两次随访评估。在预设时间，将使用有效的评估工具（偏头痛残疾评估、PHQ-D、GAD-7 和 SF-12）和头痛日记评估各项结果（疼痛强度、健康相关生活质量、疼痛持续时间、自主调节和心率变异性）以及参与者对复杂治疗的接受程度。针灸治疗将基于中医规则，包括标准化的穴位组合以及根据个体疼痛定位选择的附加穴位。训练疗法包括力量训练、耐力训练和提高柔韧性和协调性的训练。除了对样本进行描述性分析外，还将使用方差分析（ANOVA）或卡方检验评估其可比性。分析将基于意向治疗进行。潜在的交互效应将使用重复测量方差分析进行计算，以检验主要和次要假设。在补充分析中，将确定每个治疗组的治疗反应者（疼痛发作频率减少 50%的患者）的比例。
该试验可能为针灸和医学训练疗法作为联合治疗的附加效果提供证据，并可能从科学上支持这种复杂健康干预措施的实施。
2019 年 2 月 11 日注册。德国临床试验注册处，DRKS00016723。
