Risk and Protective Factors in Multimodal Pain Therapy in Patients With Chronic Lumbal Pain

NCT ID: NCT04881188

Last Updated: 2022-05-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2024-12-31

Brief Summary

Results will show important information about potential protective factors which might be relevant for the recovery of patients suffering from low back pain (theoretical basis). On a clinically applied basis we plan the validation of a short screening in concerns of psychosocial risk and protective factors in patients with chronic low back pain undergoing a multimodal pain therapy (MPT), and this for the first time.

Three main aims are: 1. Prospective validation of a short screening on a theoretical basis for the collection of psychosocial risk factors concerning of an unfavourable therapeutic process in MPT. 2. the verification of differences in subgroups with regard to pain management on a basis of the Avoidance Endurance Model in the development of pain and pain-related disability. 3. The evaluation of potential psychosocial protective factors supporting a positive outcome of MPT, such as resilience, acceptance, self-compassion, and body image.

Detailed Description

Chronic low back pain (CLBP) is one of the most common causes of disease-related disabilities with regard to work ability, physical activity, and mobility, as well as in the development of depressive disorders and cognitive impairments. The multimodal pain therapy (MPT) is a multidisciplinary offer of medical, psychlogical and physiotherapeutic treatment. Currently, MPT is the best therapeutic option. However, there are still many non-responders. It is unknown, which patients will benefit from MPT and which contents are the most effective. Besides somatic factors, the relevance of psychosocial risk factors, such as dysfunctional pain management or disstress and depression, are evident in patients suffering from CLBP. Concepts, such as the Avoidance-Endurance Model of pain (AEM) describe different pattern with regard of mood and pain management, offering an individual therapy. Patients with a fear-avoidance response pattern (FAR) and physical inactivity as well as patients with a depressive endurance response pattern (DER) and physical overactiviity show a poorer response to therapeutical and rehabilitative treatments. On the other side, patients with an adaptive response pattern (AR) and moderate physical activity, and patients with an eustress endurance response pattern (EER) react positive to MPT. If the relevance of these pattern will be shown in patients with CLBP, this would stand for a more individualised therapy concerning psychological and physiotherapeutical treatment (e.g., ExposureTherapy, Pacing). Currently it is unknown which factors are relevant for recovery in patients with AR. One possible protective factor is the personality factor "resilience". The current research situation in the field of chronic pain and resilience is still in its early days and raises the question, if partial aspects such as a high degree of pain acceptance, of self-compassion, and a positive body image show more directly and more clearly relations to a positive response to treatment. Furthermore, research has focused on cross-sectional studies. However, only prospective longitudinal studies will provide insight in cause-and-effect-relationship. On a clinically applied basis the diagnosis of risk and protective factors will play an outstanding role to establish a more individualised therapy and rehabilitation, as also the MPT.

For the diagnosis of the different pain pattern postulated by the AEM, the 9-item Avoidance Endurance Fast-Screen (AEFS) is a reliable and valid short screening. However, it has been investigated in patients with acute pain, so far. A separate validation for patients with CLPB is necessary. Our working group wants to tie up the planned prospective study to preliminary work and show for the first time processes of patients with CLBP undergoing MPT.

On a theoretical basis results will be informative about possible protective factors being important for recovery. On a clinically applied basis we plan the validation of a short-screening of psychosocial risk- and protective factors in patients with CLBP undergoing MPT.

Conditions

Chronic Low-back Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with chronic low back pain

Patients suffering from chronic low back pain (duration longer than 3 months) undergoing a multimodal pain therapy

Survey

Intervention Type: DIAGNOSTIC_TEST

Patients with chronic low back pain in in-patient multimodal pain therapy. Three survey times, questionnaires

Interventions

Survey

Patients with chronic low back pain in in-patient multimodal pain therapy. Three survey times, questionnaires

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• chronic low back pain

Exclusion Criteria

• acute inflammatory diseases
• acute fractures
• pregnancy
• neurological dieases
• psychiatric diseases

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Katholisches Klinikum Bochum

UNKNOWN

Sponsor Role: collaborator

Ruhr University of Bochum

OTHER

Sponsor Role: lead

Responsible Party

Claudia Levenig

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tobias L Schulte, Prof.

Role: STUDY_CHAIR

Katholisches Klinikum Bochum

Locations

Katholisches Klinikum, Klinik Blankenstein

Hattingen, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Claudia G Levenig, Dr.

Role: CONTACT

claudia.levenig@ruhr-uni-bochum.de

+49 234 3224994

Tobias L Schulte, Prof.

Role: CONTACT

tobias.schulte@klinikum-bochum.de

+49 234 509 2511

Facility Contacts

Claudia Levenig

Role: primary

claudia.levenig@ruhr-uni-bochum.de

+49 234 32 24994

Other Identifiers

MST2020

Identifier Type: -

Identifier Source: org_study_id