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

NCT04881188 | Unknown

• 1 other identifier: MST2020
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain

Keywords

multimodal pain therapy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Resilience Scale-13 (RS-13)

  first day of study participation

• Chronic Pain Acceptance Questionnaire (CPAQ)

  first day of study participation

• Self-compassion Scale (SCS)

  first day of study participation

• Frankfurter Körperkonzeptskalen (FKKS, Frankfurt Body Concept Scales)

  15 weeks

• Fremantle Back Awareness Questionnaire (FreBAQ)

  15 weeks

Study Arms (1)

Patients with chronic low back pain

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

Diagnostic Test: Survey

Interventions

Survey DIAGNOSTIC_TEST

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

Patients with chronic low back pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

in-patients pain clinic

You may qualify if:

• chronic low back pain

You may not qualify if:

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

Sponsors & Collaborators

• Ruhr University of Bochum: lead
• Katholisches Klinikum Bochum: collaborator

Study Sites (1)

Katholisches Klinikum, Klinik Blankenstein

Hattingen, 45527, Germany

RECRUITING

MeSH Terms

Interventions

Fertility

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Tobias L Schulte, Prof.

  Katholisches Klinikum Bochum

  STUDY CHAIR

Central Study Contacts

Claudia G Levenig, Dr.

CONTACT

+49 234 3224994; claudia.levenig@ruhr-uni-bochum.de

Tobias L Schulte, Prof.

CONTACT

+49 234 509 2511; tobias.schulte@klinikum-bochum.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 11, 2021
• Study Start: January 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: May 18, 2022

Record last verified: 2022-05

Locations

DE (1)