Clinical trial NCT04881188: Risk and Protective Factors in Multimodal Pain Therapy in Patients With Chronic Lumbal Pain
Official title: Risk and Protective Factors in Multimodal Pain Therapy in Patients With Chronic Lumbal Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Low-back Pain
Keywords: multimodal pain therapy
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
Collaborators: name: Katholisches Klinikum Bochum
First posted: 2021-05-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: in-patients pain clinic

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.

Eligibility criteria: Inclusion Criteria:

* chronic low back pain

Exclusion Criteria:

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

Primary outcomes:
measure: Chronic Pain Score (von Korff)
timeFrame: 15 weeks
measure: Chronic Disability Score (von Korff)
timeFrame: 15 weeks
Secondary outcomes:
measure: Resilience Scale-13 (RS-13)
timeFrame: first day of study participation
measure: Chronic Pain Acceptance Questionnaire (CPAQ)
timeFrame: first day of study participation
measure: Self-compassion Scale (SCS)
timeFrame: first day of study participation
measure: Frankfurter Körperkonzeptskalen (FKKS, Frankfurt Body Concept Scales)
timeFrame: 15 weeks
measure: Fremantle Back Awareness Questionnaire (FreBAQ)
timeFrame: 15 weeks
Other outcomes:
Locations:
city: Hattingen
country: Germany
facility: Katholisches Klinikum, Klinik Blankenstein
Study officials:
affiliation: Katholisches Klinikum Bochum
name: Tobias L Schulte, Prof.
role: STUDY_CHAIR
References: