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Interdisciplinary assessment in patients with chronic pain: Retrospective evaluation of the German Pain Questionnaire & Prospective questionnaire survey on patient experiences

Organizational Data

DRKS-ID:
DRKS00031001
Recruitment Status:
Recruiting planned
Date of registration in DRKS:
2023-08-10
Last update in DRKS:
2023-08-10
Registration type:
Prospective

Acronym/abbreviation of the study

No Entry

URL of the study

No Entry

Brief summary in lay language

No Entry

Brief summary in scientific language

Pain, according to the International Association for the Study Pain (IASP), is an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage. In most cases, acute pain reduces after the exogenous cause has been removed or the endogenous irritation has subsided (1). Therefore, acute pain has a warning function to indicate that damage is taking place in the body. Attention is thus to be directed to a specific region of the body. Chronic pain, on the other hand, is far more complex and, according to Casser et al, is characterised by an "interplay of somatic, psychological and social factors". This is also confirmed by the biopsychosocial model, which describes precisely this interplay of biological, psychological and social components (2). According to this model, biological processes, emotions, cognitions as well as the behaviour and social environment of the person affected influence the perception of pain (1). If the pain lasts longer or recurs over a period of 3 months, it is called chronic pain (3). The temporal dimension is therefore a decisive characteristic of chronic pain. According to Gerbershagen, factors such as constant pain, multilocality, inadequate use of medication, frequent changes of therapists and associations with psychosocial problems can be examples of a high degree of chronicity. These are risks that favour chronification. Chronic pain is a complex process that is regarded as a disease in its own right and therefore requires comprehensive therapy (2). According to a Europe-wide study, the prevalence of chronic pain in Germany was 17% with an average pain duration of seven years. Women are affected more often than men (4). This is also confirmed by a study by Willweber-Strumpf and colleagues, in which patients were asked about chronic pain. According to this study, twice as many women as men suffer from chronic pain (5). The high prevalence indicates that there is a considerable need for effective and patient-oriented therapy so that misuse and underuse can be avoided. In addition, chronic pain often leads to sick leave or inability to work, which imposes a high health economic burden with high indirect costs (4). Multimodal treatment programmes are named as the gold standard for an effective therapy of chronic pain, for the indication of which, however, a detailed diagnosis is recommended according to the National Health Care Guideline "Low Back Pain": The interdisciplinary assessment. The assessment is also defined in the coding guidelines of the BfArM with the OPS code 1-910 (Interdisciplinary Algesiological Diagnostics). The assessment should not only be seen as a diagnostic tool, but rather as the first step in the treatment process. A study by Rothman et al. was able to show that in the long term, better treatment results can be achieved in patients who have received an assessment compared to a control group who did not receive this assessment. Within the framework of an assessment, the patient is examined both (pain) medically, physiologically/motively/ergotherapeutically, and psychologically/psychosomatically. It is important that the results of the assessment are open. Of particular importance is the final interprofessional team discussion in order to grasp the complex interaction of the individual facets of the pain disease. In a final discussion, it is then decided together with the patient which form of therapy is the most sensible and effective. The assessment thus not only serves as preparation for a multimodal treatment programme. Rather, it is of great interest to the health care system in terms of health economics, since cost-intensive incorrect treatments can be avoided on the basis of the interdisciplinary therapy recommendation (6). The aim of the study is to examine the interdisciplinary assessment and to work out what position it takes in the diagnosis and therapy of people with chronic pain. These questions are investigated in the study using two different methods. Approximately 1000 German Pain Questionnaires, which were received by the Interdisciplinary Pain Centre Freiburg between July 2010 and September 2019, will be evaluated. Among other things, the German Pain Questionnaire asks questions about the current pain situation with information about pain intensity on a numerical scale. It also deals with the patient's current life situation and pain-associated suffering. Furthermore, the clinical data of those patients who presented for an assessment at the Interdisciplinary Pain Centre in Freiburg on the basis of the German Pain Questionnaire will be accessed. It will be investigated which of these patients received which therapy recommendation. The individual diagnoses and therapy recommendations are to be determined on the basis of the "assessment letter". The last question examines a specially developed questionnaire that depicts the subjective satisfaction of the patients with the assessment. This questionnaire will once again address the patient's living conditions and pain intensity. The main questions, however, will be about satisfaction with the assessment and the individual sub-interviews. The patients should fill out this questionnaire at the end of the assessment. For this purpose, about 100 questionnaires from patients who receive an assessment in the interdisciplinary pain centre in Freiburg within a period of 2-3 months will be analysed. The aim is to find out how the assessment is perceived and how satisfied the patients are with it. References: 1. Kröner-Herwig B. Schmerz als biopsychosoziales Phänomen – eine Einführung, in: Kröner-Herwig B, Frettlöh J, Klinger R, Nilges P, Hrsg. Schmerzpsychotherapie. Grundlagen - Diagnostik - Krank-heitsbilder - Behandlung. 8. Auflage. Berlin: Springer; 2017. S.3-16. 2. Wirz S. Schmerzkrankheit: somatische, psychische (yellow flags), soziale und biographische Faktoren - eine eigenständige Erkrankung?, in: Kieselbach K, Wirz S, Schenk M. Multimodale Schmerztherapie: Ein Praxislehrbuch. 1. Auflage. Stuttgart: Kohlhammer Verlag; 2021. S. 42-54 3. Treede R-D, Rief W, Barke A, Aziz Q, Bennet M, Benoliel R et al. Chronic pain as a symptom or a disease: the ISAP Classification of Chronic Pain for the International Classification of Diseases (ICD-11). Pain 2019; 160(1):19-27. 4. Schmidt C O, Chenot J-F, Kohlmann T. Epidemiologie und gesundheitsökonomische Aspekte des chronischen Schmerzes, in: Kröner-Herwig B, Frettlöh J, Klinger R, Nilges P, Hrsg. Schmerzpsycho-therapie. Grundlagen - Diagnostik - Krankheitsbilder - Behandlung. 8. Auflage. Berlin: Springer; 2017. S.17-29 5. Willweber-Strumpf A, Zenz M, Bartz D. Epidemiologie chronischer Schmerzen: Eine Befragung in 5 Facharztpraxen in Bochum. Schmerz 2000; (2):84–91. 6. Casser H-R, Arnold B, Brinkschmidt T, Gralow I, Irnich D, Klimczyk K et al. Interdisziplinäres Assessment zur multimodalen Schmerztherapie. Indikation und Leistungsumfang. Schmerz 2013; 27(4):363–70.

Health condition or problem studied

ICD10:
F45.41
Healthy volunteers:
No

Interventions, Observational Groups

Arm 1:
The aim of the retrospective data analysis is to evaluate approx. 1000 pain questionnaires of the "German Pain Society", which were received in the interdisciplinary pain centre Freiburg in the period from July 2010 to September 2019. In connection with the information from the corresponding assessment letters of the patients, descriptive information but also patterns are to be examined. The following questions will be answered:Which treatment recommendations are made and what is the percentage distribution for these different therapy suggestions? Are there certain criteria or factors that speak in favour of recommending a multimodal treatment programme? The aim of the questionnaire survey is to investigate the subjective satisfaction of the patients with the assessment. Primarily, the following question should be answered: How satisfied are the patients with the assessment (overall and with the respective therapeutic parts) and how is it perceived by the patients?

Endpoints

Primary outcome:
Primary endpoint of the retrospective data analysis: Information on diagnoses and therapy recommendations from the assessment letters in connection with the variables of the German pain questionnaire (group differences and prediction). Primary endpoint of the questionnaire survey: satisfaction with the assessment; subjective perception of the individual sub-interviews, satisfaction with the therapy recommendations.
Secondary outcome:
Secondary endpoint of the retrospective data analysis: variables of the German pain questionnaire. Secondary endpoint of the questionnaire survey: information on diagnoses and treatment recommendations from the assessment letters in connection with the variables of the questionnaire survey (group differences and prediction).

Study Design

Purpose:
Supportive care
Retrospective/prospective:
Both
Study type:
Non-interventional
Longitudinal/cross-sectional:
Longitudinal study
Study type non-interventional:
No Entry

Recruitment

Recruitment Status:
Recruiting planned
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

Recruitment period and number of participants

Planned study start date:
2023-08-14
Actual study start date:
No Entry
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
120
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
Patients with chronic pain, participation in a interdisciplinary assessment

Exclusion Criteria

Lack of intellectual or linguistic ability to answer the questionnaire in German

Addresses

Primary Sponsor

Address:
Interdisziplinäres Schmerzzentrum
Dr. med. Kristin Kieselbach
Breisacher Straße 117
79106 Freiburg
Germany
Telephone:
+49 761 270 93490
Fax:
+49 761 270 54840
Contact per E-Mail:
Contact per E-Mail
URL:
https://www.uniklinik-freiburg.de/schmerzzentrum.html
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Address:
Interdisziplinäres Schmerzzentrum
Dr. med. Kristin Kieselbach
Breisacher Straße 117
79106 Freiburg
Germany
Telephone:
+49 761 270 93490
Fax:
+49 761 270 54840
Contact per E-Mail:
Contact per E-Mail
URL:
https://www.uniklinik-freiburg.de/schmerzzentrum.html

Contact for Public Queries

Address:
Interdisziplinäres Schmerzzentrum
Dr. med. Kristin Kieselbach
Breisacher Straße 117
79106 Freiburg
Germany
Telephone:
+49 761 270 93490
Fax:
+49 761 270 54840
Contact per E-Mail:
Contact per E-Mail
URL:
https://www.uniklinik-freiburg.de/schmerzzentrum.html

Principal Investigator

Address:
Interdisziplinäres Schmerzzentrum
Dr. med. Kristin Kieselbach
Breisacher Straße 117
79106 Freiburg
Germany
Telephone:
+49 761 270 93490
Fax:
+49 761 270 54840
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
Breisacher Straße 117
79106 Freiburg
Germany
Telephone:
+49 761 270 93490
Fax:
+49 761 270 54840
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 Freiburg
Engelberger Str. 21
79106 Freiburg
Germany
Telephone:
+49-761-27072600
Fax:
No Entry
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:
2023-03-15
Ethics committee number:
23-1119-S2
Vote of the Ethics Committee:
Approved
Date of the vote:
2023-04-18

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

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