EFFects of EXPosure and Cognitive-behavioural Therapy for Chronic BACK Pain
NCT ID: NCT05294081
Last Updated: 2025-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
380 participants
INTERVENTIONAL
2022-03-01
2027-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Exploratory research will also be conducted to identify predictors of which patient groups benefit more from which method. This should optimise treatment options and create effective treatment offers for subgroups of pain patients.
Exposure therapy is an effective and economical treatment modality and was shown in a previous pilot study to be superior to CBT in reducing perceived movement limitation. CBT, on the other hand, appeared to be more effective in establishing coping strategies. With the help of the current study it should be possible to compare the effectiveness of both treatment methods and, in perspective, to identify those patient groups that benefit from exposure therapy and thus create a tailor-made treatment programme for subgroups of pain patients.
A total of 380 patients (age: ≥ 18) with chronic back pain and a sufficient degree of impairment will be included and analysed in the study.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Cognitive Behavioral Therapy in Patients With Chronic Nonspecific Low Back Pain
NCT04938739
Exposure-based Treatment for Avoidant Back Pain Patients
NCT01484418
COGNITIVE BEHAVIOURAL THERAPY FOR TREATMENT OF CHRONIC NON-SPECIFIC LOW BACK PAIN
NCT04715789
Exposure Therapy and Safety-seeking Behavior in Chronic Low Back Pain
NCT01971151
Efficacy Study of Cognitive Behavioural Treatment With Support on Communication and Information Technologies for the Management of Chronic Low Back Pain
NCT01802671
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
According to current guidelines, most of the commonly offered treatments such as injections or surgery are ineffective; only pharmacotherapy shows small effects but carries a high risk of side effects.
Cognitive behavioural therapy (CBT), multidisciplinary approaches with psychological treatment components such as CBT and exercise, supported by psychological elements, improve pain and condition-related disability in the long term. Disappointingly, however, in most studies the effects of multidisciplinary or psychological treatment approaches are small to moderate, and in the case of multidisciplinary approaches, do not always justify the high costs of inpatient programmes. In outpatient care, specific psychological services in addition to pharmacotherapy and physiotherapy are rare.
EXP treatment for pain is a rarely used psychological treatment that specifically addresses the avoidance of physical activity in people with CLBP. In a previous pilot study with 88 participants, the investigators conducted for the first time a short (10 sessions) and a longer (15 sessions) outpatient EXP therapy programme and compared it with a standard 15-session CBT programme:
* EXP was more effective than CBT in reducing movement-related impairment.
* EXP-short outperformed EXP-long in efficiency after 10 sessions, meaning that individuals improved faster when offered fewer sessions.
* EXP could be safely delivered in the outpatient psychological setting, however CBT was more effective than EXP in improving coping strategies.
A specific behavioural measure, the "BAT-BACK" test, successfully identified participants who benefited from EXP in terms of a reduction in pain-related impairment. Therefore, in the future, EXP therapy could be a tailored treatment option to achieve better treatment outcomes in subgroups of CLBP patients. However, studies with more participants are needed to further clarify whether EXP is successful and for which subgroup of patients. The proposed study would be the first to aim to find out which patient group is more likely to benefit from EXP and which from CBT.
Research question and rationale for the project:
Society is currently faced with the challenge of a widespread disease without being able to offer satisfactory treatment options. A comparison of an already established treatment method (CBT) with a still less known and used treatment method (EXP) should create starting points here. In addition, tailoring chronic pain treatment specifically to subgroups of pain patients could improve care.
In addition, EXP therapy is a promising and cost-effective treatment option that could easily be incorporated into multidisciplinary programmes for inpatients or offered by outpatient psychotherapists as part of the newly established 12-hour brief psychotherapy. In order to validate the preliminary results of the pilot study and to answer open questions, a multicentre study with a larger number of participants is implemented.
The study should also lead to a larger number of therapists trained in EXP therapy in different regions in Germany and to an increase in the visibility of the treatment manuals and could lead to a more frequent use of EXP for the benefit of the CLBP population. By publishing the results, the investigators hope to raise awareness, especially among psychological psychotherapists, that brief, manualised, focused treatments may be sufficient to reduce the burden of chronic pain. The identification of predictors will help all practitioners involved in the treatment of chronic pain to identify those patients who are more likely to benefit from EXP and those who are more likely to benefit from CBT.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
Two parallel groups are formed, the intervention group receives 10 sessions of EXP therapy, the control group receives 10 sessions of CBT.
The assignment to the therapy methods is randomised. This is a multicentre study, the study will be conducted at 5 centres throughout Germany. A total of 380 patients will be included. Per study arm, 190 patients must be included.
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Exposure (EXP)
Exposure in vivo for fear avoidant chronic low back pain patients. This treatment means that the individual is exposed to movements and tasks that have been avoided due to fear of (re)injury. The treatment begins after three educational lessons including the rational and developing a fear hierarchy. Exposure phase includes 10 exposures sessions which are highly individualized. Behavioral experiments can be included to correct catastrophic misinterpretations. The main purpose of this intervention type is to reduce pain related disability via diminishing fear avoidance.
Exposure therapy
10 sessions based on an individualized pain hierarchy
Cognitive Behavioural Therapy (CBT)
Cognitive behavioural psychotherapy for fear avoidant chronic low back patients. The therapy is modularized in three main parts. The educational lesson is followed by the module graded activity which represents the behavioral part of the program. The second module comprises relaxation. And the last part contains cognitive interventions. Cognitive behavioural intervention techniques are employed to support the patient in the process of coping with chronic pain: i.e. reduction of disability and improving functional ability.
Cognitive behavioral therapy
10 sessions with graded activity, relaxations techniques and cognitive interventions
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Exposure therapy
10 sessions based on an individualized pain hierarchy
Cognitive behavioral therapy
10 sessions with graded activity, relaxations techniques and cognitive interventions
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Sufficient level of disability, as defined by QBPDS ≥ 15 (Quebec Back Pain Disability Scale)
* Age 18 and above
* Agreeing to participate, verified by completion of informed consent
Exclusion Criteria
* Red Flags
* inability to read or write in German
* pregnancy
* severe alcohol or drug addiction
* psychotic disorders
* another current psychological treatment
* physical inability to attend sessions
* parallel participation in another intervention study
Depression will be controlled for, medication will be required to stay stable until Follow-up and any changes will be controlled for, on-demand ("rescue") medication will be not allowed.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Heidelberg University
OTHER
University of Kaiserslautern-Landau
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Julia A Glombiewski, Prof. Dr.
Role: STUDY_DIRECTOR
RPTU Kaiserslautern - Landau, Department of Clinical Psychology and Psychotherapy
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
RPTU Kaiserslautern- Landau
Landau, RLP, Germany
Essener Rückenschmerzzentrum, Universitätsklinikum Essen
Essen, , Germany
Schmerzzentrum, Ruprechts - Karls Universität Heidelberg
Heidelberg, , Germany
Poliklinische Institutsambulanz für Psychotherapie
Mainz, , Germany
Phillips-Universität Marburg
Marburg, , Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Freburger JK, Holmes GM, Agans RP, Jackman AM, Darter JD, Wallace AS, Castel LD, Kalsbeek WD, Carey TS. The rising prevalence of chronic low back pain. Arch Intern Med. 2009 Feb 9;169(3):251-8. doi: 10.1001/archinternmed.2008.543.
Chenot JF, Greitemann B, Kladny B, Petzke F, Pfingsten M, Schorr SG. Non-Specific Low Back Pain. Dtsch Arztebl Int. 2017 Dec 25;114(51-52):883-890. doi: 10.3238/arztebl.2017.0883.
Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Denberg TD, Barry MJ, Boyd C, Chow RD, Fitterman N, Harris RP, Humphrey LL, Vijan S. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017 Apr 4;166(7):514-530. doi: 10.7326/M16-2367. Epub 2017 Feb 14.
Bernstein IA, Malik Q, Carville S, Ward S. Low back pain and sciatica: summary of NICE guidance. BMJ. 2017 Jan 6;356:i6748. doi: 10.1136/bmj.i6748. No abstract available.
Eccleston C, Morley SJ, Williams AC. Psychological approaches to chronic pain management: evidence and challenges. Br J Anaesth. 2013 Jul;111(1):59-63. doi: 10.1093/bja/aet207.
Kamper SJ, Apeldoorn AT, Chiarotto A, Smeets RJ, Ostelo RW, Guzman J, van Tulder MW. Multidisciplinary biopsychosocial rehabilitation for chronic low back pain. Cochrane Database Syst Rev. 2014 Sep 2;2014(9):CD000963. doi: 10.1002/14651858.CD000963.pub3.
Glombiewski JA, Holzapfel S, Riecke J, Vlaeyen JWS, de Jong J, Lemmer G, Rief W. Exposure and CBT for chronic back pain: An RCT on differential efficacy and optimal length of treatment. J Consult Clin Psychol. 2018 Jun;86(6):533-545. doi: 10.1037/ccp0000298.
Holzapfel S, Schemer L, Riecke J, Glombiewski JA. Behavioral Test (BAT-Back): Preliminary Evidence for a Successful Predictor of Treatment Outcome After Exposure Treatment for Chronic Low Back Pain. Clin J Pain. 2021 Apr 1;37(4):265-269. doi: 10.1097/AJP.0000000000000920.
Hasenbring MI, Verbunt JA. Fear-avoidance and endurance-related responses to pain: new models of behavior and their consequences for clinical practice. Clin J Pain. 2010 Nov-Dec;26(9):747-53. doi: 10.1097/AJP.0b013e3181e104f2.
de Jong JR, Vlaeyen JWS, Onghena P, Cuypers C, den Hollander M, Ruijgrok J. Reduction of pain-related fear in complex regional pain syndrome type I: the application of graded exposure in vivo. Pain. 2005 Aug;116(3):264-275. doi: 10.1016/j.pain.2005.04.019.
Vogt R, Haas J, Baumann L, Sander A, Klose C, Riecke J, Rief W, Bingel U, Maser D, Witthoft M, Kessler J, Zugaj MR, Ditzen B, Glombiewski JA. EFFects of Exposure and Cognitive behavioral Therapy for chronic BACK pain ("EFFECT-BACK"): study protocol for a randomized controlled trial. Trials. 2024 Mar 11;25(1):176. doi: 10.1186/s13063-024-08017-9.
Kuntz B, Hoebel J, Fuchs J, Neuhauser H, Lampert T. [Social inequalities in the prevalence of chronic back pain among adults in Germany]. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2017 Jul;60(7):783-791. doi: 10.1007/s00103-017-2568-z. German.
van Tulder M, Koes B. Chronic low back pain. Am Fam Physician. 2006 Nov 1;74(9):1577-9. No abstract available.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan: Main project
Document Type: Study Protocol and Statistical Analysis Plan: Amendment
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EFFECT-BACK1/2022
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.