Ignite Creation Date:
2024-05-06 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 2:28 PM
Study NCT ID:
NCT05294081
Status:
RECRUITING
Last Update Posted:
2023-10-06
First Post:
2022-03-02
Brief Title:
EFFects of EXPosure and Cognitive-behavioural Therapy for Chronic BACK Pain
Sponsor:
University of Kaiserslautern-Landau
Organization:
University of Kaiserslautern-Landau
Study Overview
Official Title:
EFFECT-BACK Tackling Back Pain - Effects of Exposure Therapy and Cognitive Behavioural Therapy for Chronic Back Pain
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EFFECT-BACK
Brief 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
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
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 171 and one in four women 244 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None