The Influence of Interdisciplinary Multimodal Pain Therapy on Cerebral Connectivity in Chronic Pain Patients
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| ClinicalTrials.gov Identifier: NCT03634670 |
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Recruitment Status :
Completed
First Posted : August 16, 2018
Last Update Posted : October 8, 2020
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Chronic Pain, Interdisciplinary Multimodal Pain Therapy, Electroencephalography, Functional Connectivity | Other: Interdisciplinary multimodal pain therapy (IMPT) |
| Study Type : | Observational |
| Actual Enrollment : | 41 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | The Influence of Interdisciplinary Multimodal Pain Therapy on Cerebral Connectivity in Chronic Pain Patients |
| Actual Study Start Date : | January 9, 2018 |
| Actual Primary Completion Date : | June 30, 2020 |
| Actual Study Completion Date : | June 30, 2020 |
- Other: 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.
- Change from baseline visual analogue scale (VAS) ratings of pain intensity at 6 months [ Time Frame: Measured at baseline and at 6 months post treatment ]Pain rating for average Pain intensity within the last 4 weeks on the VAS ranging from 0=no pain to 10=worst imaginable pain
- Change from baseline Pain related disability / Quality of life / Depression / Pain characteristics at 6 months [ Time Frame: Measured at baseline and at 6 months post treatment ]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)
- Change from baseline functional cerebral connectivity as assessed by resting-state Electroencephalography (EEG) at 6 months [ Time Frame: Measured at baseline and 6 months post treatment ]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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03634670
| Germany | |
| Department of Neurology, Center for Interdisciplinary Pain Medicine, Klinikum rechts der Isar, TUM | |
| Munich, Bavaria, Germany, 81675 | |
| Principal Investigator: | Markus Ploner, Professor, MD | Department of Neurology, Klinikum rechts der Isar, TUM |
| Responsible Party: | Technische Universität München |
| ClinicalTrials.gov Identifier: | NCT03634670 |
| Other Study ID Numbers: |
01/2018 |
| First Posted: | August 16, 2018 Key Record Dates |
| Last Update Posted: | October 8, 2020 |
| Last Verified: | October 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Chronic Pain Pain Neurologic Manifestations |