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Low Back PainETABPNCT01484418

Exposure-based Treatment for Avoidant Back Pain Patients

A study testing Exposure in vivo and Cognitive Behavioural Psychotherapy in people with Low Back Pain, run by Philipps University Marburg at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Chronic low back pain often results in psychosocial and physical disability. A subgroup of these patients shows fear of (re)injury and avoidance behaviour leading to higher disability. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Low Back Pain
What is being tested?
Exposure in vivo and Cognitive Behavioural Psychotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteGermany
Study dates
Aug 2011to Aug 2017
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Having at least 3 months back pain
  • Sufficient level on fear avoidance scores (TSK, Phoda)
  • Being German-speaking
  • Agreeing to participate, verified by completion of informed consent

Who cannot join

  • Red flags
  • Pregnancy
  • Illiteracy
  • Psychoses
  • Alcohol addiction
  • surgeries during the last 6 months or planed surgeries
  • Specific medical disorders or cardiovascular diseases preventing participation in physical exercise
  • Participating in another psychotherapy

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Philipps University Marburg, Department of Clinical Psychology and Psychotherapy

    Marburg, 35037

Other trials in Germany

About this study

Official title: Exposure Therapy in Chronic Low Back Pain Patients

Chronic low back pain often results in psychosocial and physical disability. A subgroup of these patients shows fear of (re)injury and avoidance behaviour leading to higher disability. The purpose of this study is to determine whether exposure in vivo is more effective in the treatment of fear avoidant chronic back pain patients than psychological treatment as usual (cognitive behavioural psychotherapy).

Conditions
Low Back Pain
Being tested
Exposure in vivo, Cognitive Behavioural Psychotherapy
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
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exposure in vivoBehavioural

    5-10 sessions based on an individualized fear hierarchy

  • Cognitive Behavioural PsychotherapyBehavioural

    graded activity, relaxation techniques and cognitive interventions

Study groups in NCT01484418
Study groupRoleWhat they receive
A Exposure longExperimentalExposure 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 in vivo
B Exposure shortExperimentalSee above exposure long. This treatment comprises 5 exposure sessions.
Receives: Behavioral: Exposure in vivo
C Cognitive behavioural psychotherapyActive comparatorCognitive 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 Behavioural Psychotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in pain severity at 3 and 6 months after admission

    Numeric Rating Scale (NRS)

    Measured: from Pretest (admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)

  2. Change from baseline in pain disability at 3 and 6 months after admission

    Pain Disability Index (PDI) Quebec Back Pain Disability Scale (QBPDS)

    Measured: from Pretest (admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)

Secondary outcomes (5)

  1. Change in fear avoidance from Pretest to two in-between time points to Posttest

    Tampa Scale of Kinesiophobia (TSK) Pain Anxiety Symptom Scale (PASS)

    Measured: from Pretest (admission) to one in-between timepoint (an expected 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)

  2. Change in pain catastrophizing from Pretest to two in-between timepoints to Posttest to Follow-up

    Pain Catastrophizing Scale (PCS)

    Measured: from Pretest (admission) to one in-between timepoint (an expected 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)

  3. Change in emotional distress from Pretest to two in-between timepoints to Posttest to Follow-up

    Hospital Anxiety and Depression Scale (HADS)

    Measured: from Pretest (admission) to one in-between timepoint (an expected 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)

  4. Change in quality of life from Pretest to two in-between timepoints to Posttest to Follow-up

    EuroQol (EQ-5D)

    Measured: from Pretest (admission) to one in-between timepoint (an expected 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)

  5. Change in physical activity from Pretest to two in-between timepoints to Posttest to Follow-up Time

    International Physical Activity Questionnaire(IPAQ)

    Measured: from Pretest (admission) to one in-between timepoint (an expected 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionAug 2015
  4. Study completionAug 2017

Resources

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
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01484418
Sponsor's protocol ID
DFG-GL 607
Acronym
ETABP
Status last verified
Sep 2017
First submitted
28 Nov 2011
Last updated
5 Sep 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 29781651

  • Riecke J, Holzapfel S, Rief W, Glombiewski JA. Evaluation and implementation of graded in vivo exposure for chronic low back pain in a German outpatient setting: a study protocol of a randomized controlled trial. Trials. 2013 Jul 9;14:203. doi: 10.1186/1745-6215-14-203.

    PubMed 23837551

Questions about this trial

What is this clinical trial studying?

A study testing Exposure in vivo and Cognitive Behavioural Psychotherapy in people with Low Back Pain, run by Philipps University Marburg 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 4 inclusion and 8 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 5 Sep 2017. 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?

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 from baseline in pain severity at 3 and 6 months after admission (time frame: from Pretest (admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)). 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?

On the ClinicalTrials.gov record for NCT01484418, which also lists 2 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 5 Sep 2017; AzTrials last refreshed its copy on 4 Nov 2026.

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