The Influence of Interdisciplinary Multimodal Pain Therapy on Cerebral Connectivity in Chronic Pain Patients

NCT ID: NCT03634670

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 41 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-09
• Study Completion Date: 2020-06-30

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.

Conditions

Chronic Pain, Interdisciplinary Multimodal Pain Therapy, Electroencephalography, Functional Connectivity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Interdisciplinary multimodal pain therapy (IMPT)

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Research Foundation

OTHER

Sponsor Role: collaborator

Technical University of Munich, Center for Interdisciplinary Pain Medicine, Klinikum rechts der Isar

UNKNOWN

Sponsor Role: collaborator

Technical University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Markus Ploner, Professor, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, Klinikum rechts der Isar, TUM

Locations

Department of Neurology, Center for Interdisciplinary Pain Medicine, Klinikum rechts der Isar, TUM

Munich, Bavaria, Germany

Countries

Germany

References

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Reference Type: BACKGROUND

PMID: 21146929 (View on PubMed)

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Reference Type: BACKGROUND

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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.

Reference Type: DERIVED

PMID: 35050961 (View on PubMed)

Other Identifiers

01/2018

Identifier Type: -

Identifier Source: org_study_id