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

Chronic Low-back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04881188
• Other study ID #: MST2020
• Status: Recruiting
• Start date: January 2023
• Est. completion date: December 2024

Study information

• Verified date: May 2022
• Source: Ruhr University of Bochum
• Contact: Claudia G Levenig, Dr.
• Phone: +49 234 3224994
• Email: claudia.levenig[@]ruhr-uni-bochum.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• chronic low back pain

Exclusion Criteria:

• acute inflammatory diseases

• acute fractures

• pregnancy

• neurological dieases

• psychiatric diseases

Related Conditions & MeSH terms

• Chronic Low-back Pain
• Low Back Pain

Intervention

Diagnostic Test:
• Survey
Patients with chronic low back pain in in-patient multimodal pain therapy. Three survey times, questionnaires

Locations

Country	Name	City	State
Germany	Katholisches Klinikum, Klinik Blankenstein	Hattingen

Sponsors (2)

Lead Sponsor	Collaborator
Ruhr University of Bochum	Katholisches Klinikum Bochum

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic Pain Score (von Korff)	change of pain intensity from baseline to 3-months-follow up (three time points); minimum value 0 (no pain), maximum value 10 (worst pain possible), higher scores mean a worse outcome	15 weeks
Primary	Chronic Disability Score (von Korff)	change of pain-related disability from baseline to 3-months-follow up (three time points); minimum value 0 (no disability), maximum value 10 (worst disability possible), higher scores mean a worse outcome	15 weeks
Secondary	Resilience Scale-13 (RS-13)	resilience - thinking and action; 7-point-scale (1 I do not agree - 7 I totally agree); higher scores indicate higher levels of resilience	first day of study participation
Secondary	Chronic Pain Acceptance Questionnaire (CPAQ)	Acceptance of chronic pain (subscales "pain willingness" and "activity engagement"), 7-point-scale (0 never - 6 always true); higher scores indicate higher levels of acceptance	first day of study participation
Secondary	Self-compassion Scale (SCS)	Self-compassion - how individuals typically act towards themself in difficult times; subscales: self-kindness, self-judgement, common humanity, isolation, mindfulness, over-identification; 5-point-scale (1 almost never - 5 almost always); mean score; higher scores indicate higher levels of self-compassion	first day of study participation
Secondary	Frankfurter Körperkonzeptskalen (FKKS, Frankfurt Body Concept Scales)	body image - cognitions of health, self-efficacy and self-acceptance (three subscales); 7 point-scale (1 I strongly agree - 6 I strongly disagree); higher scores indicate a more positive body image	15 weeks
Secondary	Fremantle Back Awareness Questionnaire (FreBAQ)	body image - perception of the back; 5-point-scale (0 never feels like that - 4 Always, or most of the time feels like that); higher scores indicate a poor outcome	15 weeks