An observational study in Chronic Pain, Interdisciplinary Multimodal Pain Therapy, Electroencephalography, Functional Connectivity, sponsored by Technical University of Munich. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-08.
Sponsored by Technical University of Munich · Observational
Due to its high prevalence and the substantial individual and socio-economic burden chronic pain is a huge challenge for patients, physicians and the society. Using neuroimaging structural and functional alterations have been described in the brain of patients suffering from chronic pain (Apkarian, Hashmi et al. 2011, Baliki and Apkarian 2015). However, reproducibility and functional significance of these changes are only incompletely understood. For example it remains unclear, if these changes covariate with clinical parameters and if they can be influenced or reversed by appropriate therapy. Some of the structural and functional brain changes in chronic pain patients have been shown to be reversible using magnetic resonance imaging after successful interventional pain treatment (Seminowicz, Wideman et al. 2011) or cognitive-behavioral therapy (Seminowicz, Shpaner et al. 2013, Shpaner, Kelly et al. 2014). Interdisciplinary multimodal pain therapy (IMPT) as a biopsychosocial treatment approach comprising physiotherapy and psychotherapy in structured programs has been shown to be effective in alleviating chronic pain of different entities including those where interventional therapy options are lacking or have been unsuccessful (Kaiser, Treede et al. 2017). The present study aims to investigate the influence of a structured IMPT approach provided in a day-clinic program of 20 treatment days on the functional brain network structure in chronic pain patients. To this end, a graph-theory based analysis (Bullmore and Sporns 2009) will be applied to electroencephalography (EEG) resting-state data from 30 chronic pain patients before and after IMPT and results will be correlated with behavioral and clinical data. In this observational study chronic pain patients that have been screened for participation in IMPT as part of routine medical care are invited to participate in a baseline visit prior to participation and a follow-up visit 6 months after completion of the program.
This will add to a better understanding of the complex functional brain alterations in chronic pain and might contribute to identify neuronal markers or even predictors for therapeutic responses in multimodal pain treatments. Moreover, the broad availability and easy applicability of EEG-measurements might enable a wide therapeutic application of potential findings in the near future.
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's enrollment of 41 is below the median of 126 across 688 observational studies indexed under Chronic Pain.
Browse Chronic Pain studies →Technical University of Munich is the lead sponsor of 315 studies on the registry; 55 are open to participants now.
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All chronic pain patients eligible according to the inclusion and exclusion criteria (see eligibility criteria) participating in the IMPT-day-clinic programme of the Center for Interdisciplinary Pain Medicine at the Klinikum rechts der Isar of the Technische Universität München in the year 2018 are invited to voluntarily participate in the study.
Exclusion Criteria:
The IMPT-program is provided in a specialized day-clinic setting over a period of 20 treatment days. There are two different treatment programs with either 5 days per week over a period of 4 weeks or 3 days per week over a period of 7 weeks. IMPT comprises individual pharmacotherapy evaluated in regular consultations with a physician as well as a structured physiotherapy and psychotherapy programs on group level and individual level. Group physiotherapy comprises exercise therapy, movement experience and relaxation techniques. Additionally individual physiotherapy is provided in two extra sessions focusing on the individual needs and problems of the patient. Group psychotherapy comprises educational contents (e.g. pathophysiology and biopsychosocial aspects of pain) as well as cognitive-behavioral-interventions e.g. regarding stress-management. Additionally individual psychotherapy is provided in four extra sessions focusing on the individual needs and problems of the patient.
Change from baseline visual analogue scale (VAS) ratings of pain intensity at 6 months
Pain rating for average Pain intensity within the last 4 weeks on the VAS ranging from 0=no pain to 10=worst imaginable pain
Time frame: Measured at baseline and at 6 months post treatment
Change from baseline Pain related disability / Quality of life / Depression / Pain characteristics at 6 months
Metrics assessed using the German Pain Questionnaire (Nagel, Gerbershagen et al. 2002), short-form McGill Pain Questionnaire (Melzack 1987), Beck Depression Inventory II (Beck et al 1986), painDETECT Questionnaire (Freynhagen et al 2006)
Time frame: Measured at baseline and at 6 months post treatment
Change from baseline functional cerebral connectivity as assessed by resting-state Electroencephalography (EEG) at 6 months
64-Channel-EEG resting state measurements and Graph-theory based analysis of frequency bands (gamma, beta, alpha, theta, delta) on sensor and source level including degree centrality, clustering coefficient, global efficiency, small-worldness, modularity und global hub disruption index
Time frame: Measured at baseline and 6 months post treatment
Plan to share: Undecided
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Technical University of Munich