Long-term effects of multimodal pain therapy
Organizational Data
- DRKS-ID:
- DRKS00017685
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2019-08-07
- Last update in DRKS:
- 2022-09-29
- Registration type:
- Retrospective
Acronym/abbreviation of the study
MMT Longterm
URL of the study
No Entry
Brief summary in lay language
Interdisciplinary multimodal pain therapy is based on the bio-psychosocial pain model and has been established in the treatment of chronic pain in recent years. With the present study, it shall be examined whether, respectively, to which extent there are effects of multimodal pain therapy beyond a time interval of one year after therapy. For the study, all patients, who had been treated in the Interdisciplinary Pain Center, (University Hospital Freiburg) with a multimodal pain therapy of at least four weeks duration within a timeframe of six years are eligible. With a questionnaire, data on pain scores (mean, lowest and highest pain score during the preceding two weeks, pain score regarded as a bearable), depression, anxiety, stress, pain related disability and the current employment status. The data shall be compared to data prior to treatment taken from the patient’s charts. With this study, it should be elucidated whether there is a long term therapeutic effect. Moreover, possible prognostic factors for the long-term effects should be identified.
Brief summary in scientific language
Interdisciplinary multimodal pain therapy is based on the bio-psychosocial pain model and has been established in the treatment of chronic pain in recent years. The efficiency of multimodal pain therapy has been shown in a variety of studies. Systematic reviews showed that regarding pain reduction, the effect sizes of multimodal pain therapy are relatively modest. Larger effect sizes can be reached regarding functionality, and particularly regarding the return to work rate. To date there are only few long term observations with a follow-up of more than one year after multimodal pain therapy. Most studies on multimodal pain therapy do not examine intervals of more than one year after therapy. Already within this timeframe, in some studies, a reduction of the effects induced by multimodal pain therapy was observed. With the present study, it shall be examined whether respectively, to which extent there are effects of multimodal pain therapy beyond a time interval of one year after therapy. For the study, all patients, who had been treated in the Interdisciplinary Pain Center, (University Hospital Freiburg) with a multimodal pain therapy of at least four weeks duration within a timeframe of six years are eligible. With a questionnaire, data on pain scores (mean, lowest and highest pain score during the preceding two weeks, pain score regarded as a bearable), depression, anxiety, stress, pain related disability and the current employment status. The data shall be compared to data prior to treatment taken from the patient’s charts. With this study, it should be elucidated whether there is a long term therapeutic effect. Moreover, possible prognostic factors for the long-term effects should be identified.
Health condition or problem studied
- ICD10:
- F45.41
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- With a questionnaire, data on pain scores (mean, lowest and highest pain score during the preceding two weeks, pain score regarded as a bearable), depression, anxiety, stress, pain related disability and the current employment status.
Endpoints
- Primary outcome:
- Mean, highest, lowest and acceptable pain strength on the NRS (numerical rating scale) at time of follow-up
- Secondary outcome:
- Depression/anxiety/stress, quality of life, pain related invalidity, employment status
Study Design
- Purpose:
- Treatment
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Interdisziplinäres Schmerzzentrum Freiburg im Breisgau
Recruitment period and number of participants
- Planned study start date:
- 2019-07-21
- Actual study start date:
- 2019-07-21
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 500
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 80 Years
- Additional Inclusion Criteria:
- Day hospital multimodal pain therapy in the ISZ between 1.1.2013 and 31.12.2018.
Exclusion Criteria
Incompleteness of questionnaire, severe psychiatric comorbidity, missing language skills to understand questionnaire
Addresses
Primary Sponsor
- Address:
- Interdisziplinäres Schmerzzentrum Universitätsklinikum FreiburgDr. med. Tilman WolterBreisacherstr. 6479106 FreiburgGermany
- Telephone:
- +49/761/2705203
- Fax:
- +49/761/2705013
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Interdisziplinäres Schmerzzentrum UKL FreiburgPD Dr. med. Tilman WolterBreisacherstr.11779106 FreiburgGermany
- Telephone:
- 0761/27054801
- Fax:
- 0761/27054990
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uniklinik-freiburg.de/schmerzzentrum.html
Contact for Public Queries
- Address:
- Interdisziplinäres Schmerzzentrum UKL FreiburgPD Dr. med. Tilman WolterBreisacherstr.11779106 FreiburgGermany
- Telephone:
- 0761/27054801
- Fax:
- 0761/27054990
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uniklinik-freiburg.de/schmerzzentrum.html
Principal Investigator
- Address:
- Interdisziplinäres Schmerzzentrum UKL FreiburgPD Dr. med. Tilman WolterBreisacherstr.11779106 FreiburgGermany
- Telephone:
- 0761/27054801
- Fax:
- 0761/27054990
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uniklinik-freiburg.de/schmerzzentrum.html
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Interdisziplinäres Schmerzzentrum UKL FreiburgBreisacherstr.11779106 FreiburgGermany
- Telephone:
- 0761/27054810
- Fax:
- 0761/27054990
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uniklinik-freiburg.de/schmerzzentrum.html
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Albert-Ludwigs-Universität FreiburgEngelberger Str. 2179106 FreiburgGermany
- Telephone:
- +49-761-27072600
- Fax:
- +49-761-27072630
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2018-11-19
- Ethics committee number:
- 517/18
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2019-03-19
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- All study data will be published. Raw data will be published as supplementary data.
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry