Chronic Pain, Interdisciplinary Multimodal Pain Therapy, Electroencephalography, Functional ConnectivityNCT03634670
The Influence of Interdisciplinary Multimodal Pain Therapy on Cerebral Connectivity in Chronic Pain Patients
An observational study of Chronic Pain, Interdisciplinary Multimodal Pain Therapy, Electroencephalography, Functional Connectivity, run by Technical University of Munich at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Interdisciplinary Multimodal Pain Therapy, Electroencephalography, Functional Connectivity
- What is being tested?
- Interdisciplinary multimodal pain therapy (IMPT)
- How many people
- 41 participants
- Where
- 1 siteGermany
- Study dates
- 9 Jan 2018to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Neurology, Center for Interdisciplinary Pain Medicine, Klinikum rechts der Isar, TUM
Munich, Bavaria, 81675
About this study
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.
- Being tested
- Interdisciplinary multimodal pain therapy (IMPT)
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interdisciplinary multimodal pain therapy (IMPT)Other
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at baseline and at 6 months post treatment
Secondary outcomes (1)
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: Measured at baseline and at 6 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start9 Jan 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Chronic Pain, Interdisciplinary Multimodal Pain Therapy, Electroencephalography, Functional ConnectivityStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Sponsor
- Investigators
- Markus Ploner, Professor, MD, Principal investigator, Department of Neurology, Klinikum rechts der Isar, TUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03634670
- Sponsor's protocol ID
- 01/2018
- Status last verified
- Oct 2020
- First submitted
- 14 May 2018
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21146929Baliki 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.
PubMed 26247858Bullmore 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.
PubMed 19190637Kaiser 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.
PubMed 28328572Nagel B, Gerbershagen HU, Lindena G, Pfingsten M. [Development and evaluation of the multidimensional German pain questionnaire]. Schmerz. 2002 Aug;16(4):263-70. doi: 10.1007/s00482-002-0162-1. German.
PubMed 12192435Seminowicz 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.
PubMed 24135432Seminowicz 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.
PubMed 21593339Shpaner 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.
PubMed 26958466Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.
PubMed 3670870Beck, A.T., Steer, R.A., & Brown, G.K. (1996). Manual for the Beck Depression Inventory-II. San Antonio, TX: Psychological Corporation.
Freynhagen R, Baron R, Gockel U, Tolle 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. doi: 10.1185/030079906X132488.
PubMed 17022849Heitmann 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.
PubMed 35050961
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Interdisciplinary Multimodal Pain Therapy on Cerebral Connectivity in Chronic Pain Patients
- ClinicalTrials.gov ID
- NCT03634670
- Acronym / sponsor ID
- 01/2018
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- 9 Jan 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 16 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Background: PubMed 21146929Apkarian 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.
- Background: PubMed 26247858Baliki 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.
- Background: PubMed 19190637Bullmore 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.
- Background: PubMed 28328572Kaiser 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.
- Background: PubMed 12192435Nagel B, Gerbershagen HU, Lindena G, Pfingsten M. [Development and evaluation of the multidimensional German pain questionnaire]. Schmerz. 2002 Aug;16(4):263-70. doi: 10.1007/s00482-002-0162-1. German.
- Background: PubMed 24135432Seminowicz 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.
- Background: PubMed 21593339Seminowicz 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.
- Background: PubMed 26958466Shpaner 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.
- Background: PubMed 3670870Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.
- BackgroundBeck, A.T., Steer, R.A., & Brown, G.K. (1996). Manual for the Beck Depression Inventory-II. San Antonio, TX: Psychological Corporation.
- Background: PubMed 17022849Freynhagen R, Baron R, Gockel U, Tolle 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. doi: 10.1185/030079906X132488.
- Derived from this study: PubMed 35050961Heitmann 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Ploner, Professor, MD principal investigator
Department of Neurology, Klinikum rechts der Isar, TUM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, Interdisciplinary Multimodal Pain Therapy, Electroencephalography, Functional Connectivity, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03634670, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.