A randomized controlled trial of acupuncture and receptive music therapy for sleep disorders in the elderly-ELAMUS: study protocol.

BACKGROUND: Globally, the demographic shift towards an aging population leads to significant challenges in healthcare systems, specifically due to an increasing incidence of multimorbidity resulting in polypharmacy among the elderly. Simultaneously, sleep disorders are a common complaint for elderly people. A treatment with pharmacological therapies often leads to side effects causing a high potential for dependency. Within this context, there is a high need to explore non-pharmacological therapeutic approaches. The purpose of this study is to evaluate the effectiveness of acupuncture and music therapy, both individually and combined as a multimodal therapy, in the treatment of sleep disorders in individuals aged 70 years and older. METHODS: We conduct a confirmatory randomized controlled trial using a two-factorial study design. A total of n = 100 elderly people receive evidence-based standard care information for age-related sleep disorders. Beyond that, patients are randomly assigned into four groups of n = 25 each to receive acupuncture, receptive music therapy with a monochord, multimodal therapy with both acupuncture and music therapy, or no further therapy. The study's primary outcome measurement is the improvement in sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) (global score), at the end of intervention. Additionally, depression scores (Geriatric Depression Scale), health-related quality of life (Short-Form-Health Survey-12), neurovegetative activity measured via heart rate variability, and safety data are collected as secondary outcomes. Using a mixed-methods approach, a qualitative process evaluation will be conducted to complement the quantitative data. DISCUSSION: The study is ongoing and the last patient in is expected to be enrolled in April 2024. The results can provide valuable insights into the effectiveness of non-pharmacological interventions for sleep disorders among the elderly, contributing to a more personalized and holistic approach in geriatric healthcare. TRIAL REGISTRATION: German Clinical Trials Register (DRKS00031886).

Increasing Warmth in Adolescents with Anorexia Nervosa: A Randomized Controlled Crossover Trial Examining the Efficacy of Mustard and Ginger Footbaths.

OBJECTIVE: To analyze the thermogenic effects of footbaths with medicinal powders in adolescents with anorexia nervosa (AN) in comparison to healthy controls (HCs). Intervention and Outcomes. Forty-one female participants (21 AN, 20 HCs; 14.22 ± 1.54 years) received three footbaths-warm water and mustard (MU, Sinapis nigra), warm water and ginger (GI, Zingiber officinale), or warm water only (WA), in random order within a crossover design. Data were collected before (t1), immediately after foot immersion (maximum 20 minutes) (t2), and after 10 minutes subsequently (t3). Actual skin temperature (high resolution thermography) and perceived warmth (HeWEF questionnaire) were assessed at each time point for various body parts. The primary outcome measure was self-perceived warmth at the feet at t3. Secondary outcome measures were objective skin temperature and subjective warmth at the face, hands, and feet. RESULTS: Perceived warmth at the feet at t3 was significantly higher after GI compared to WA (mean difference -1.02) and MU (-1.07), with no differences between those with AN and HC (-0.29). For the secondary outcome measures, a craniocaudal temperature gradient for the skin temperature (thermography) was noted at t1 for patients with AN and HC (AN with colder feet). The craniocaudal gradient for subjective warmth was only seen for patients with AN. CONCLUSION: Footbaths with ginger increased warmth perception at the feet longer than with mustard or warm water only for adolescents with AN as well as for HC. The impact of ginger footbaths on recovery of thermoregulatory disturbances in patients with AN repeated over extended periods merits further investigation.

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.

BACKGROUND: 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. 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 REGISTRATION: Registered on 11 Feburary 2019. German Clinical Trials Register, DRKS00016723.

Functional MRI of the Brainstem: Common Problems and their Solutions.

Functional magnetic resonance imaging (fMRI) of the brainstem is a relatively young field that is rapidly evolving. While it is still difficult to obtain usable fMRI signals from this complicated brain region, the past few years have seen a number of important advances that bring us closer to routine application of this method in the clinical and scientific setting. This review gives an overview of the technical capabilities and limitations of brainstem fMRI. It explains the major brainstem-specific problems and gives advice on how to avoid or counteract them. In particular, I discuss how spatial resolution issues can be overcome by using appropriate sequences, coils, and spatial preprocessing, how the effects of physiological noise can be mitigated by noise modeling and spatial masking, and how the functional heterogeneity of brainstem nuclei needs to be taken into account, when planning a study. Solving these common problems is a prerequisite for any scientist or clinician interested in applying fMRI to measure brainstem activity.

Insular dysfunction and descending pain inhibition in anorexia nervosa.

OBJECTIVE: Reduced perception of pain is a well-established phenomenon in patients with anorexia nervosa (AN). We tested the hypothesis that altered processing of pain within the insula might account for reduced perception of pain. METHOD: Heat pain thresholds were obtained in nineteen patients with AN and matched controls. Thereafter, a thermode was used to deliver thermal painful stimuli to the right arm during functional magnetic resonance imaging (fMRI) measurements. Stimuli were initiated for 10 s from a baseline resting temperature (32°C) to three different levels (37, 42, 45°C). RESULTS: Significantly increased heat pain thresholds were observed in patients. A stronger activation during heat pain perception was found in the left posterior insula in controls. In contrast, higher levels of activity were shown in the ipsilateral pons in patients when compared to controls. In patients, we found a significant interrelation between the depression score (Beck depression inventory) and heat pain activations. CONCLUSION: We suggest that reduced activity in the left posterior insula might contribute to increased pain thresholds in patients, while increased activations in the right anterior insula and pons mirror augmented sympathetic modulation putatively related to amplification of adrenergic descending pain inhibition. In addition, pain thresholds and brain activations were influenced by disease-inherent depressed mood.

[Illustrations of visceral referred pain. "Head-less" Head's zones]. / Illustrationen zum übertragenen Schmerz. Wie viel von Head steckt in den Head-Zonen?

Reviewing anatomical, physiological and neurological standard literature for illustrations of referred visceral pain only one type of illustration can frequently be found, which is referred to as Treves and Keith. In fact, the original illustration as a model for most current pictures stems from the German edition of Sir Frederick Treves' famous book "Surgical Applied Anatomy" from 1914, which was reillustrated for didactical reasons for the German readership. While neither Treves and Keith nor the German illustrator Otto Kleinschmidt ever published any work on referred pain this illustration must have been adapted or copied from older sources by the illustrator. Therefore the comprehensive systematic original works before 1914 were reviewed, namely those of Sir Henry Head and Sir James Mackenzie. Due to the name of the phenomenon in the German literature of Head's zones, the illustrations were expected to be based mainly on Head's work. However, a comparison of all available illustrations led to the conclusion that Kleinschmidt chiefly used information from Mackenzie as a model for his illustration. Due to the inexact reproduction of Mackenzie's work by the illustrator some important features were lost that had been reported by the original authors. These include the phenomenon of Head's maximum points, which nowadays has fallen into oblivion.Therefore current charts, based on the illustration by Kleinschmidt from 1914, lack experimental evidence and appear to be a simplification of the observational results of both Head's and Mackenzie's original systematic works.