Chronic Pain, Interdisciplinary Multimodal Pain Therapy, Electroencephalography, Functional Connectivity Clinical Trial
Official title:
The Influence of Interdisciplinary Multimodal Pain Therapy on Cerebral Connectivity in Chronic Pain Patients
| NCT number | NCT03634670 |
| Other study ID # | 01/2018 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 9, 2018 |
| Est. completion date | June 30, 2020 |
| Verified date | October 2020 |
| Source | Technische Universität München |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | 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.
| Status | Completed |
| Enrollment | 41 |
| Est. completion date | June 30, 2020 |
| Est. primary completion date | June 30, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Department of Neurology, Center for Interdisciplinary Pain Medicine, Klinikum rechts der Isar, TUM | Munich | Bavaria |
| Lead Sponsor | Collaborator |
|---|---|
| Technische Universität München | German Research Foundation, Technical University of Munich, Center for Interdisciplinary Pain Medicine, Klinikum rechts der Isar, Technical University of Munich, Faculty of Medicine |
Germany,
Apkarian AV, Hashmi JA, Baliki MN. Pain and the brain: specificity and plasticity of the brain in clinical chronic pain. Pain. 2011 Mar;152(3 Suppl):S49-64. doi: 10.1016/j.pain.2010.11.010. Epub 2010 Dec 13. Review. — View 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. Review. — View Citation
Beck, A.T., Steer, R.A., & Brown, G.K. (1996). Manual for the Beck Depression Inventory-II. San Antonio, TX: Psychological Corporation.
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. Review. Erratum in: Nat Rev Neurosci. 2009 Apr;10(4):312. — View Citation
Freynhagen R, Baron R, Gockel U, Tölle TR. painDETECT: a new screening questionnaire to identify neuropathic components in patients with back pain. Curr Med Res Opin. 2006 Oct;22(10):1911-20. — View 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. — View Citation
Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-7. — View Citation
Nagel B, Gerbershagen HU, Lindena G, Pfingsten M. [Development and evaluation of the multidimensional German pain questionnaire]. Schmerz. 2002 Aug;16(4):263-70. German. — View 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. — View 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. — View 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. — View Citation
* Note: There are 11 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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 | Measured at baseline and 6 months post treatment | |
| Primary | 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 | Measured at baseline and at 6 months post treatment | |
| Secondary | 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) | Measured at baseline and at 6 months post treatment |