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NCT Number: NCT01484418

Exposure-based Treatment for Avoidant 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).

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Philipps University Marburg, Department of Clinical Psychology and Psychotherapy

Marburg, 35037, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exposure in vivo

Behavioral

5-10 sessions based on an individualized fear hierarchy

Cognitive Behavioural Psychotherapy

Behavioral

graded activity, relaxation techniques and cognitive interventions

Primary outcomes

  1. 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)

    Numeric Rating Scale (NRS)

  2. Change from baseline in pain disability 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)

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

Secondary outcomes

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

    Time frame: 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)

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

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

    Time frame: 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)

    Pain Catastrophizing Scale (PCS)

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

    Time frame: 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)

    Hospital Anxiety and Depression Scale (HADS)

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

    Time frame: 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)

    EuroQol (EQ-5D)

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

    Time frame: 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)

    International Physical Activity Questionnaire(IPAQ)

Sponsors and collaborators

Lead sponsor

Philipps University Marburg

Other

Collaborators

  • German Research Foundation
  • Psychotherapie-Ambulanz Marburg e.V.

Registry information

Official study title

Exposure Therapy in Chronic Low Back Pain Patients

Acronym: ETABP

Important dates

Study start
2011
Primary completion
2015
Study completion
2017
First posted
Dec 2, 2011
Registry last updated
Sep 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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