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☐ ☆ ✇ BMJ Open

Evaluation of a manualised neurofeedback training in psychosomatic-psychotherapeutic outpatient treatment (Neuro-pp-out): study protocol for a clinical mixed-methods pilot study

Por: Schmidt · K. L. · Kowalski · A. · Schweda · A. · Dörrie · N. · Skoda · E. M. · Bäuerle · A. · Teufel · M. — Abril 17th 2024 at 17:18
Introduction

Electroencephalographic neurofeedback (NFB), as a non-invasive form of brainwave training, has been shown to be effective in the treatment of various mental health disorders. However, only few results regarding manualised and standardised NFB trainings exist. This makes comparison as well as replication of studies difficult. Therefore, we developed a standard manual for NFB training in patients with mental health disorders attending a psychosomatic outpatient clinic. The current study aims at investigating the conduction of a standardised manual for NFB training in patients with mental health disorders. If successful, the study provides new opportunities to investigate NFB in a more controlled and comparable manner in clinical practice.

Methods and analysis

30 patients diagnosed with a mental health disorder will be included. After the educational interview, patients will undergo baseline diagnostics (T0). The subsequent intervention consists of 10 sessions of NFB training aiming at increasing sensorimotor rhythm and alpha-frequency amplitudes and decreasing theta-frequency and high beta-frequency amplitudes to induce relaxation and decrease subjective stress. All patients will undergo a post-treatment diagnostic assessment (T1) and a follow-up assessment 8 weeks following the closing session (T2). Changes in amplitude bands (primary outcome) will be recorded with electroencephalography during pre-assessments, post-assessments and follow-up assessments and during NFB sessions. Physiological (respiratory rate, blood volume pulse, muscle tension) and psychometric parameters (distress, perceived stress, relaxation ability, depressive and anxiety symptoms, insomnia, self-efficacy and quality of life) will be assessed at T0, T1 and T2. Moreover, satisfaction, acceptance and usability will be assessed at T1 after NFB training. Further, qualitative interviews about the experiences with the intervention will be conducted with NFB practitioners 6 months after the study starts. Quantitative data will be analysed using repeated measures analysis of variance as well as mediation analyses on mixed linear models. Qualitative data will be analysed using Mayring’s content analysis.

Ethics and dissemination

The study was approved by the ethics committee of the Medical Faculty of the University of Duisburg-Essen (23–11140-BO) and patient enrolment began in April 2023. Before participation, written informed consent by each participant will be required. Results will be published in peer-reviewed journals and conference presentations.

Trial registration number

Prospectively registered on 28 March 2023 in the German clinical trials register, DRKS00031497.

☐ ☆ ✇ PLOS ONE Medicine&Health

Physical measures of physical functioning as prognostic factors to predict outcomes in low back pain: Protocol for a systematic review

Por: Rameeza Rashed · Katie Kowalski · David Walton · Afieh Niazigharemakhe · Alison Rushton — Diciembre 11th 2023 at 15:00

by Rameeza Rashed, Katie Kowalski, David Walton, Afieh Niazigharemakhe, Alison Rushton

Background

Low back pain (LBP) is a highly prevalent condition that substantially impairs individuals’ physical functioning. This highlights the need for effective management strategies to improve patient outcomes. It is, therefore, crucial to have knowledge of physical functioning prognostic factors that can predict outcomes to facilitate the development of targeted treatment plans aiming to achieve better patient outcomes. There is no synthesis of evidence for physical functioning measures as prognostic factors in the LBP population. The objective of this systematic review is to synthesize evidence for physical measures of physical functioning as prognostic factors to predict outcomes in LBP.

Methods

The protocol is registered in the International Prospective Register of Systematic Reviews and reported in line with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P). Prospective longitudinal observational studies investigating potential physical prognostic factors in LBP and/or low back-related leg pain population will be included, with no restriction on outcome. Searches will be performed in MEDLINE, EMBASE, Scopus, CINAHL databases, grey literature search using Open Grey System and ProQuest Dissertations and Theses, hand-searching journals, and reference lists of included studies. Two independent reviewers will evaluate the eligibility of studies, extract data, assess risk of bias and quality of evidence. Risk of bias will be assessed using the Quality in Prognostic Studies (QUIPS) tool. Adequacy of clinical, methodological, and statistical homogeneity among included studies will decide quantitative (meta-analysis) or qualitative analysis (narrative synthesis) focused on prognostic factors and strength of association with outcomes. Quality of cumulative evidence will be evaluated using a modified Grading of Recommendations Assessment, Development, and Evaluation (GRADE).

Discussion

Information about prognostic factors can be used to predict outcomes in LBP. Accurate outcome prediction is essential for identifying high-risk patients that allows targeted allocation of healthcare resources, ultimately reducing the healthcare burden.

Registration

PROSPERO, CRD42023406796.

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