Chronic Low-back PainNCT04881188
Risk and Protective Factors in Multimodal Pain Therapy in Patients With Chronic Lumbal Pain
An observational study of Chronic Low-back Pain, run by Ruhr University of Bochum at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Survey
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2023to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: in-patients pain clinic
Who may be able to join
- chronic low back pain
Who cannot join
- acute inflammatory diseases
- acute fractures
- pregnancy
- neurological dieases
- psychiatric diseases
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Katholisches Klinikum, Klinik Blankenstein
Hattingen, 45527
Claudia Levenig, +49 234 32 24994, claudia.levenig@ruhr-uni-bochum.de
About this study
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.
Read the 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
- Being tested
- Survey
- Keywords
- multimodal pain therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyDiagnostic test
Patients with chronic low back pain in in-patient multimodal pain therapy. Three survey times, questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic low back pain | Patients suffering from chronic low back pain (duration longer than 3 months) undergoing a multimodal pain therapy Receives: Diagnostic Test: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 15 weeks
Secondary outcomes (5)
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
Measured: first day of study participation
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
Measured: first day of study participation
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
Measured: first day of study participation
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
Measured: 15 weeks
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
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study startJan 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Collaborators
- Katholisches Klinikum Bochum
- Responsible party
- Principal investigator, Claudia Levenig, Ruhr University of Bochum
- Investigators
- Tobias L Schulte, Prof., Study chair, Katholisches Klinikum Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881188
- Sponsor's protocol ID
- MST2020
- Status last verified
- May 2022
- First submitted
- 30 Apr 2021
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk and Protective Factors in Multimodal Pain Therapy in Patients With Chronic Lumbal Pain
- ClinicalTrials.gov ID
- NCT04881188
- Acronym / sponsor ID
- MST2020
- Conditions
- Chronic Low-back Pain
- Keywords
- multimodal pain therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Collaborators
- Katholisches Klinikum Bochum
- Study start
- Jan 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 11 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic low back pain | – | Diagnostic Test: SurveyPatients suffering from chronic low back pain (duration longer than 3 months) undergoing a multimodal pain therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- in-patients pain clinic
Key inclusion criteria (1 listed)
- chronic low back pain
Key exclusion criteria (5 listed)
- acute inflammatory diseases
- acute fractures
- pregnancy
- neurological dieases
- psychiatric diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyPatients with chronic low back pain in in-patient multimodal pain therapy. Three survey times, questionnaires | Diagnostic test | Patients with chronic low back pain |
Primary outcome
Chronic Pain Score (von Korff)
Time frame: 15 weeks
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
Chronic Disability Score (von Korff)
Time frame: 15 weeks
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
5 secondary outcomes
Resilience Scale-13 (RS-13)
Time frame: first day of study participation
Chronic Pain Acceptance Questionnaire (CPAQ)
Time frame: first day of study participation
Self-compassion Scale (SCS)
Time frame: first day of study participation
Frankfurter Körperkonzeptskalen (FKKS, Frankfurt Body Concept Scales)
Time frame: 15 weeks
Fremantle Back Awareness Questionnaire (FreBAQ)
Time frame: 15 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tobias L Schulte, Prof. study chair
Katholisches Klinikum Bochum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Low-back Pain, run by Ruhr University of Bochum at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claudia G Levenig, Dr. (+49 234 3224994, claudia.levenig@ruhr-uni-bochum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic Pain Score (von Korff) (time frame: 15 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.