Chronic Low Back PainEFFECT-BACKNCT05294081
EFFects of EXPosure and Cognitive-behavioural Therapy for Chronic BACK Pain
A study testing Exposure therapy and Cognitive behavioral therapy in people with Chronic Low Back Pain, run by University of Kaiserslautern-Landau at 5 sites in Germany.
Trial summary
The overall aim of the present study is to compare two different psychological methods, Cognitive Behavioural Therapy (CBT) and Graduated Exposure in vivo (EXP) in the treatment of chronic back pain with regard to effectiveness and improvement of pain related disability. 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?
- Exposure therapy and Cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 5 sitesGermany
- Study dates
- 1 Mar 2022to 31 Mar 2026
- Phase
- Interventional
- 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
Who may be able to join
- Chronic low back pain (duration > 6 months, pain on most days of the week)
- 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
Who cannot join
- Back surgeries during the last six months or planned surgeries
- Red Flags
- inability to read or write in German
- pregnancy
- severe alcohol or drug addiction
- psychotic disorders
Show all 10Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Essener Rückenschmerzzentrum, Universitätsklinikum Essen
Essen, 45147
Schmerzzentrum, Ruprechts - Karls Universität Heidelberg
Heidelberg, 69120
RPTU Kaiserslautern- Landau
Landau, RLP, 76829
Poliklinische Institutsambulanz für Psychotherapie
Mainz, 55122
Phillips-Universität Marburg
Marburg, 35037
About this study
Official title: EFFECT-BACK: Tackling Back Pain - Effects of Exposure Therapy and Cognitive Behavioural Therapy for Chronic Back Pain
The overall aim of the present study is to compare two different psychological methods, Cognitive Behavioural Therapy (CBT) and Graduated Exposure in vivo (EXP) in the treatment of chronic back pain with regard to effectiveness and improvement of pain related disability.
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.
Read more
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.
Read the detailed description
According to a recently published study by the Robert Koch Institute with over 62 000 participants, one in six men (17.1%) and one in four women (24.4%) in Germany reported having suffered from chronic low back pain (CLBP) in the last 12 months. CLBP is a major cause of medical costs, absenteeism and disability. Despite apparent advances in medical care, the prevalence of CLBP continues to rise.
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
- Chronic Low Back Pain
- Being tested
- Exposure therapy, Cognitive behavioral therapy
- Keywords
- Chronic Low Back Pain, Cognitive Behavioural Therapy, Exposure, Fear Avoidance, Cognitive Behavioural Therapy in chronic low back pain, Exposure in vivo in chronic low back pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure therapyBehavioural
10 sessions based on an individualized pain hierarchy
Cognitive behavioral therapyBehavioural
10 sessions with graded activity, relaxations techniques and cognitive interventions
| Study group | Role | What they receive |
|---|---|---|
| Exposure (EXP) | Experimental | 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. Receives: Behavioral: Exposure therapy |
| Cognitive Behavioural Therapy (CBT) | Active comparator | 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. Receives: Behavioral: Cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain related disability
Clinically significant change in pain-related impairment at the end of therapy and at 6-months and 2-years follow-up compared to baseline.
Quebec Back Pain Disability Scale (QBPDS). Each item is scored from 0 to 5 (0 = not difficult at all, 5 = unable to do). Higher total scores reflect higher disability.
Measured: from Baseline to Posttest (an expected average of 15 weeks) to Follow Up Assessments (an expected average of 6 months after Posttest and 2 years after Posttest)
Secondary outcomes (8)
Change in pain disability
Clinically significant change in pain-related impairment at the end of therapy and at 6-months and 2-years follow-up compared to baseline.
Pain Disability Index (PDI). Each item is scored from 0 to 10 (0 = no disability, 10 = maximum disability). Higher total scores reflect higher interference of pain with daily activities.
Measured: from Baseline to Posttest (an expected average of 15 weeks) to Follow Up Assessments (an expected average of 6 months and 2 years after Posttest)
Change in pain intensity
Clinically significant change in pain intensity at the end of therapy and at 6-months and 2-years follow-up compared to baseline.
adjusted 11-point Scale of the German Pain Questionaire (Deutscher Schmerzfragebogen, DSF). 3 Items, each item is scored from 0 to 10 (e.g. 0 = no pain, 10 = strongest pain). A higher score reflects stronger pain.
Measured: from Baseline to Posttest (an expected average of 15 weeks) to Follow Up Assessments (an expected average of 6 months and 2 years after Posttest)
Change in coping
Change in coping at the end of therapy and at 6-month and 2-years follow-up compared to baseline.
Coping scale from the German questionnaire for the assessment of pain processing (Fragebogen zur Erfassung der Schmerzverarbeitung, FESV-BW). Each item is scored from 1 to 6 (1 = not true at all, 6 = completely true). Higher total scores reflect more frequent use of different coping strategies.
Measured: from Baseline to Posttest (an expected average of 15 weeks) to Follow Up Assessments (an expected average of 6 months and 2 years after Posttest)
Change in emotional distress
Change in depression at the end of therapy and at 6-months and 2-years follow-up compared to baseline.
Depression scale of the Hospital Anxiety and Depression Scale (HADS). Each item is scored from 0 to 3. Higher total scores reflect stronger anxiety or depressiveness.
Measured: from Baseline to Posttest (an expected average of 15 weeks) to Follow Up Assessments (an expected average of 6 months and 2 years after Posttest)
Change in pain catastrophizing
Change in catastrophizing at the end of therapy and at 6-months and 2-years follow-up compared to baseline.
Pain Catastrophizing Scale (PCS). Each item is scored on a scale of 0 to 4 (0 = not at all, 4 = all the time). Higher total scores reflect more catastrophising thoughts.
Measured: from Baseline to Posttest (an expected average of 15 weeks) to Follow Up Assessments (an expected average of 6 months and 2 years after Posttest)
Change in kinesiophobia
Change in kinesiophobia at the end of therapy and at 6-months and 2-years follow-up compared to baseline.
Photo Series of Daily Activities (PHODA). Each item is scored from 0 to 100 (0 = not harmful at all, 100 = extremely harmful). Higher scores reflect higher perceived harmfulness.
Measured: from Baseline to Posttest (an expected average of 15 weeks) to Follow Up Assessments (an expected average of 6 months and 2 years after Posttest)
Change in pain anxiety
Change in pain anxiety avoidance at the end of therapy and at 6-months and 2-years follow-up compared to baseline.
Pain Anxiety Symptom Scale (PASS-20). Each item is scored from 0 to 5 (0 = never, 5 = always). Higher total scores reflect more fear of pain.
Measured: from Baseline to Posttest (an expected average of 15 weeks) to Follow Up Assessments (an expected average of 6 months and 2 years after Posttest)
Change in psychological inflexibility
Change in psychological inflexibility at the end of therapy and at 6-months and 2-years follow-up compared to baseline.
Psychological Inflexibility in Pain Scale (PIPS). Each item is scored from 1 to 7 (1 = never true, 7 = always true). Higher total scores reflect higher inflexibility because of pain.
Measured: from Baseline to Posttest (an expected average of 15 weeks) to Follow Up Assessments (an expected average of 6 months and 2 years after Posttest)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start1 Mar 2022
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, multicentre, randomised, controlled, open-label, two-arm intervention study with a parallel group design. 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.
- Masking
- None (open label)
- Enrolment
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kaiserslautern-Landau
- Sponsor type
- University, hospital or other
- Collaborators
- Heidelberg University
- Responsible party
- Sponsor
- Investigators
- Julia A Glombiewski, Prof. Dr., Study director, RPTU Kaiserslautern - Landau, Department of Clinical Psychology and Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294081
- Sponsor's protocol ID
- EFFECT-BACK1/2022
- Acronym
- EFFECT-BACK
- Status last verified
- Aug 2026
- First submitted
- 2 Mar 2022
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28516263van Tulder M, Koes B. Chronic low back pain. Am Fam Physician. 2006 Nov 1;74(9):1577-9. No abstract available.
PubMed 17111899Freburger 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.
PubMed 19204216Chenot 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.
PubMed 29321099Qaseem 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.
PubMed 28192789Bernstein 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.
PubMed 28062522Eccleston 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.
PubMed 23794646Kamper 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.
PubMed 25180773Glombiewski 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.
PubMed 29781651Holzapfel 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.
PubMed 33555697Hasenbring 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.
PubMed 20664333de 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.
PubMed 15964686Vogt 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.
PubMed 38468293
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT-BACK: Tackling Back Pain - Effects of Exposure Therapy and Cognitive Behavioural Therapy for Chronic Back Pain
- ClinicalTrials.gov ID
- NCT05294081
- Acronym / sponsor ID
- EFFECT-BACK / EFFECT-BACK1/2022
- Conditions
- Chronic Low Back Pain
- Keywords
- Chronic Low Back Pain, Cognitive Behavioural Therapy, Exposure, Fear Avoidance, Cognitive Behavioural Therapy in chronic low back pain, Exposure in vivo in chronic low back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- University of Kaiserslautern-LandauUniversity, hospital or other
- Collaborators
- Heidelberg University
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 24 Mar 2022 (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.
The overall aim of the present study is to compare two different psychological methods, Cognitive Behavioural Therapy (CBT) and Graduated Exposure in vivo (EXP) in the treatment of chronic back pain with regard to effectiveness and improvement of pain related disability.
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.
Detailed description
According to a recently published study by the Robert Koch Institute with over 62 000 participants, one in six men (17.1%) and one in four women (24.4%) in Germany reported having suffered from chronic low back pain (CLBP) in the last 12 months. CLBP is a major cause of medical costs, absenteeism and disability. Despite apparent advances in medical care, the prevalence of CLBP continues to rise.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, multicentre, randomised, controlled, open-label, two-arm intervention study with a parallel group design. 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.
| Arm | Type | Receives |
|---|---|---|
| Exposure (EXP) | Experimental | Behavioral: Exposure therapyExposure 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. |
| Cognitive Behavioural Therapy (CBT) | Active comparator | Behavioral: Cognitive behavioral therapyCognitive 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic low back pain (duration > 6 months, pain on most days of the week)
- 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
Key exclusion criteria (10 listed)
- Back surgeries during the last six months or planned surgeries
- Red Flags
- inability to read or write in German
- pregnancy
- severe alcohol or drug addiction
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 |
|---|---|---|
| Exposure therapy10 sessions based on an individualized pain hierarchy | Behavioural | Exposure (EXP) |
| Cognitive behavioral therapy10 sessions with graded activity, relaxations techniques and cognitive interventions | Behavioural | Cognitive Behavioural Therapy (CBT) |
Primary outcome
Change in pain related disability
Time frame: from Baseline to Posttest (an expected average of 15 weeks) to Follow Up Assessments (an expected average of 6 months after Posttest and 2 years after Posttest)
Clinically significant change in pain-related impairment at the end of therapy and at 6-months and 2-years follow-up compared to baseline. Quebec Back Pain Disability Scale (QBPDS). Each item is scored from 0 to 5 (0 = not difficult at all, 5 = unable to do). Higher total scores reflect higher disability.
8 secondary outcomes
Change in pain disability
Time frame: from Baseline to Posttest (an expected average of 15 weeks) to Follow Up Assessments (an expected average of 6 months and 2 years after Posttest)
Change in pain intensity
Time frame: from Baseline to Posttest (an expected average of 15 weeks) to Follow Up Assessments (an expected average of 6 months and 2 years after Posttest)
Change in coping
Time frame: from Baseline to Posttest (an expected average of 15 weeks) to Follow Up Assessments (an expected average of 6 months and 2 years after Posttest)
Change in emotional distress
Time frame: from Baseline to Posttest (an expected average of 15 weeks) to Follow Up Assessments (an expected average of 6 months and 2 years after Posttest)
Change in pain catastrophizing
Time frame: from Baseline to Posttest (an expected average of 15 weeks) to Follow Up Assessments (an expected average of 6 months and 2 years after Posttest)
Change in kinesiophobia
Time frame: from Baseline to Posttest (an expected average of 15 weeks) to Follow Up Assessments (an expected average of 6 months and 2 years after Posttest)
Change in pain anxiety
Time frame: from Baseline to Posttest (an expected average of 15 weeks) to Follow Up Assessments (an expected average of 6 months and 2 years after Posttest)
Change in psychological inflexibility
Time frame: from Baseline to Posttest (an expected average of 15 weeks) to Follow Up Assessments (an expected average of 6 months and 2 years after Posttest)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Background: PubMed 28516263Kuntz 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.
- Background: PubMed 17111899van Tulder M, Koes B. Chronic low back pain. Am Fam Physician. 2006 Nov 1;74(9):1577-9. No abstract available.
- Background: PubMed 19204216Freburger 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.
- Background: PubMed 29321099Chenot 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.
- Background: PubMed 28192789Qaseem 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.
- Background: PubMed 28062522Bernstein 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.
- Background: PubMed 23794646Eccleston 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.
- Background: PubMed 25180773Kamper 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.
- Background: PubMed 29781651Glombiewski 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.
- Background: PubMed 33555697Holzapfel 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.
- Background: PubMed 20664333Hasenbring 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.
- Background: PubMed 15964686de 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.
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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.
Julia A Glombiewski, Prof. Dr. study director
RPTU Kaiserslautern - Landau, Department of Clinical Psychology and Psychotherapy
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure therapy and Cognitive behavioral therapy in people with Chronic Low Back Pain, run by University of Kaiserslautern-Landau at 5 sites 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain related disability (time frame: from Baseline to Posttest (an expected average of 15 weeks) to Follow Up Assessments (an expected average of 6 months after Posttest and 2 years after Posttest)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05294081, which also lists 13 linked publications.
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 12 Aug 2026.