Exposure-based Treatment for Avoidant Back Pain Patients

NCT ID: NCT01484418

Last Updated: 2017-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2017-08-31

Brief Summary

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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).

Detailed Description

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Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A Exposure long

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.

Group Type EXPERIMENTAL

Exposure in vivo

Intervention Type BEHAVIORAL

5-10 sessions based on an individualized fear hierarchy

B Exposure short

See above exposure long. This treatment comprises 5 exposure sessions.

Group Type EXPERIMENTAL

Exposure in vivo

Intervention Type BEHAVIORAL

5-10 sessions based on an individualized fear hierarchy

C Cognitive behavioural psychotherapy

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.

Group Type ACTIVE_COMPARATOR

Cognitive Behavioural Psychotherapy

Intervention Type BEHAVIORAL

graded activity, relaxation techniques and cognitive interventions

Interventions

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Exposure in vivo

5-10 sessions based on an individualized fear hierarchy

Intervention Type BEHAVIORAL

Cognitive Behavioural Psychotherapy

graded activity, relaxation techniques and cognitive interventions

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Psychotherapie-Ambulanz Marburg e.V.

OTHER

Sponsor Role collaborator

German Research Foundation

OTHER

Sponsor Role collaborator

Philipps University Marburg

OTHER

Sponsor Role lead

Responsible Party

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Julia Anna Glombiewski

Ph.D, Licensed Psychologist, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Winfried Rief, Prof.

Role: STUDY_DIRECTOR

Philipps University Marburg, Department of Clinical Psychology and Psychotherapy

Julia A. Glombiewski, Dr.

Role: STUDY_CHAIR

Philipps University Marburg, Department of Clinical Psychology and Psychotherapy

Locations

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Philipps University Marburg, Department of Clinical Psychology and Psychotherapy

Marburg, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 29781651 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23837551 (View on PubMed)

Related Links

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Other Identifiers

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DFG-GL 607

Identifier Type: -

Identifier Source: org_study_id

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