Exposure-based Treatment for Avoidant Back Pain Patients

NCT01484418 | Completed

• 1 other identifier: DFG-GL 607
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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. 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

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 (2)

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

  Numeric Rating Scale (NRS)

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

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

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

  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)

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

  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)

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

  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)

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

  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)

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

  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)

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

  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)

Study Arms (3)

A Exposure long

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 in vivo

B Exposure short

EXPERIMENTAL

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

Behavioral: Exposure in vivo

C Cognitive behavioural psychotherapy

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 Behavioural Psychotherapy

Interventions

Exposure in vivo BEHAVIORAL

5-10 sessions based on an individualized fear hierarchy

A Exposure long; B Exposure short

Cognitive Behavioural Psychotherapy BEHAVIORAL

graded activity, relaxation techniques and cognitive interventions

C Cognitive behavioural psychotherapy

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philipps University Marburg: lead
• Psychotherapie-Ambulanz Marburg e.V.: collaborator
• German Research Foundation: collaborator

Study Sites (1)

Philipps University Marburg, Department of Clinical Psychology and Psychotherapy

Marburg, 35037, Germany

Location

Related Publications (2)

• 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 DERIVED

• 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.

  PMID: 23837551 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Winfried Rief, Prof.

  Philipps University Marburg, Department of Clinical Psychology and Psychotherapy

  STUDY DIRECTOR

• Julia A. Glombiewski, Dr.

  Philipps University Marburg, Department of Clinical Psychology and Psychotherapy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D, Licensed Psychologist, Principal Investigator

Study Record Dates

• First Submitted: November 28, 2011
• First Posted: December 2, 2011
• Study Start: August 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2017
• Last Updated: September 5, 2017

Record last verified: 2017-09

Locations

DE (1)