Clinical trial NCT03634670: The Influence of Interdisciplinary Multimodal Pain Therapy on Cerebral Connectivity in Chronic Pain Patients
Official title: The Influence of Interdisciplinary Multimodal Pain Therapy on Cerebral Connectivity in Chronic Pain Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain, Interdisciplinary Multimodal Pain Therapy, Electroencephalography, Functional Connectivity
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: German Research Foundation
name: Technical University of Munich, Center for Interdisciplinary Pain Medicine, Klinikum rechts der Isar
First posted: 2018-08-16
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Chronic pain (duration \>6 months, not primary headache disease)
* Willing and able to comply with physical (e.g. able to get up from the floor without help) and psychological (e.g. motivation for behavioural change) requirements of the IMPT-day-clinic setting as assessed by a physician, psychologist and physiotherapist on a screening visit as part of routine medical care prior to participation
* Willing and able to sign informed consent for study participation

Exclusion Criteria:

* Recent change in chronic pain condition (e.g. surgery or injury within the last 3 months)
* Concomitant neurological or psychiatric disease apart from Depression (especially severe mental disorder or psychopathology)
* Regular (daily) intake of benzodiazepines
* Addiction problems

Primary outcomes:
measure: Change from baseline visual analogue scale (VAS) ratings of pain intensity at 6 months
timeFrame: Measured at baseline and at 6 months post treatment
Secondary outcomes:
measure: Change from baseline Pain related disability / Quality of life / Depression / Pain characteristics at 6 months
timeFrame: Measured at baseline and at 6 months post treatment
Other outcomes:
measure: Change from baseline functional cerebral connectivity as assessed by resting-state Electroencephalography (EEG) at 6 months
timeFrame: Measured at baseline and 6 months post treatment
Locations:
city: Munich
country: Germany
facility: Department of Neurology, Center for Interdisciplinary Pain Medicine, Klinikum rechts der Isar, TUM
state: Bavaria
Study officials:
affiliation: Department of Neurology, Klinikum rechts der Isar, TUM
name: Markus Ploner, Professor, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Apkarian VA, Hashmi JA, Baliki MN. Pain and the brain: specificity and plasticity of the brain in clinical chronic pain. Pain. 2011 Mar;152(3 Suppl):S49-S64. doi: 10.1016/j.pain.2010.11.010. Epub 2010 Dec 13.
citation: Baliki MN, Apkarian AV. Nociception, Pain, Negative Moods, and Behavior Selection. Neuron. 2015 Aug 5;87(3):474-91. doi: 10.1016/j.neuron.2015.06.005.
citation: Bullmore E, Sporns O. Complex brain networks: graph theoretical analysis of structural and functional systems. Nat Rev Neurosci. 2009 Mar;10(3):186-98. doi: 10.1038/nrn2575. Epub 2009 Feb 4.
citation: Kaiser U, Treede RD, Sabatowski R. Multimodal pain therapy in chronic noncancer pain-gold standard or need for further clarification? Pain. 2017 Oct;158(10):1853-1859. doi: 10.1097/j.pain.0000000000000902. No abstract available.
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citation: Seminowicz DA, Shpaner M, Keaser ML, Krauthamer GM, Mantegna J, Dumas JA, Newhouse PA, Filippi CG, Keefe FJ, Naylor MR. Cognitive-behavioral therapy increases prefrontal cortex gray matter in patients with chronic pain. J Pain. 2013 Dec;14(12):1573-84. doi: 10.1016/j.jpain.2013.07.020. Epub 2013 Oct 14.
citation: Seminowicz DA, Wideman TH, Naso L, Hatami-Khoroushahi Z, Fallatah S, Ware MA, Jarzem P, Bushnell MC, Shir Y, Ouellet JA, Stone LS. Effective treatment of chronic low back pain in humans reverses abnormal brain anatomy and function. J Neurosci. 2011 May 18;31(20):7540-50. doi: 10.1523/JNEUROSCI.5280-10.2011.
citation: Shpaner M, Kelly C, Lieberman G, Perelman H, Davis M, Keefe FJ, Naylor MR. Unlearning chronic pain: A randomized controlled trial to investigate changes in intrinsic brain connectivity following Cognitive Behavioral Therapy. Neuroimage Clin. 2014 Jul 23;5:365-76. doi: 10.1016/j.nicl.2014.07.008. eCollection 2014.
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citation: Heitmann H, Gil Avila C, Nickel MM, Ta Dinh S, May ES, Tiemann L, Hohn VD, Tolle TR, Ploner M. Longitudinal resting-state electroencephalography in patients with chronic pain undergoing interdisciplinary multimodal pain therapy. Pain. 2022 Sep 1;163(9):e997-e1005. doi: 10.1097/j.pain.0000000000002565. Epub 2021 Dec 15.