EFFects of EXPosure and Cognitive-behavioural Therapy for Chronic BACK Pain

NCT05294081 | Active Not Recruiting DMC

• 1 other identifier: EFFECT-BACK1/2022
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 5

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  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

  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)

Study Arms (2)

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.

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.

Behavioral: Cognitive behavioral therapy

Interventions

Exposure therapy BEHAVIORAL

10 sessions based on an individualized pain hierarchy

Exposure (EXP)

Cognitive behavioral therapy BEHAVIORAL

10 sessions with graded activity, relaxations techniques and cognitive interventions

Cognitive Behavioural Therapy (CBT)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of Kaiserslautern-Landau: lead
• Heidelberg University: collaborator

Study Sites (5)

RPTU Kaiserslautern- Landau

Landau, RLP, 76829, Germany

Location

Essener Rückenschmerzzentrum, Universitätsklinikum Essen

Essen, 45147, Germany

Location

Schmerzzentrum, Ruprechts - Karls Universität Heidelberg

Heidelberg, 69120, Germany

Location

Poliklinische Institutsambulanz für Psychotherapie

Mainz, 55122, Germany

Location

Phillips-Universität Marburg

Marburg, 35037, Germany

Location

Related Publications (13)

• 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.

  PMID: 28516263 BACKGROUND

• van Tulder M, Koes B. Chronic low back pain. Am Fam Physician. 2006 Nov 1;74(9):1577-9. No abstract available.

  PMID: 17111899 BACKGROUND

• 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.

  PMID: 19204216 BACKGROUND

• 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.

  PMID: 29321099 BACKGROUND

• 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.

  PMID: 28192789 BACKGROUND

• 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.

  PMID: 28062522 BACKGROUND

• 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.

  PMID: 23794646 BACKGROUND

• 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.

  PMID: 25180773 BACKGROUND

• 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.

  PMID: 29781651 BACKGROUND

• 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.

  PMID: 33555697 BACKGROUND

• 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.

  PMID: 20664333 BACKGROUND

• 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.

  PMID: 15964686 BACKGROUND

• 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.

  PMID: 38468293 DERIVED

MeSH Terms

Interventions

Implosive Therapy; Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Julia A Glombiewski, Prof. Dr.

  RPTU Kaiserslautern - Landau, Department of Clinical Psychology and Psychotherapy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 24, 2022
• Study Start: March 1, 2022
• Primary Completion: October 31, 2025
• Study Completion (Estimated): October 31, 2027
• Last Updated: May 20, 2025

Record last verified: 2025-05

Locations

DE (5)