Cognitive-behavioural Treatment of Chronic Back Pain

September 27, 2017 updated by: Winfried Rief, Philipps University Marburg Medical Center

Study to Compare a Cognitive-behavioral Treatment With a Cognitive-behavioral Treatment With Biofeedback Elements to Patients With Chronic (Low) Back Pain

The purpose of the study:

  • to compare two cognitive-behavioral treatments

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

128 patients suffering from chronic back pain were randomly assigned to either Wait List Control, Cognitive Behavioral Treatment or Cognitive Behavioral Treatment and Biofeedback.

Measures were conducted 6 months before treatment (Wait List Control) immediately before and after treatment and at 6-months follow-up.

25 weekly 1-hr sessions of individualized outpatient cognitive behavioral treatment of chronic back pain

Treatment elements:

Cognitive treatment: identification, evaluation and correction of dysfunctional beliefs about themselves and pain by cognitive restructuring, problem-solving training and coping skills training

Behavioural treatment: increasing activity levels (sports, social activities, work), reducing medication intake and unnecessary health care utilization Relaxation training: progressive muscle relaxation, biofeedback.

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Marburg, Hessen, Germany, 35032
        • University Marburg, Department of Clinical Psychology and Psychotherapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Back pain since 6 months

Exclusion Criteria:

  • Patients with psychosis, borderline psychopathy, drug dependence i.e. alcohol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
cognitive-behavioral treatment
Behavioral: cognitive-behavioral treatment
Active Comparator: 2
cognitive-behavioral treatment with biofeedback elements
Behavioral: cognitive-behavioral treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pain intensity
Time Frame: start of treatment, end of treatment, 6-months follow-up
start of treatment, end of treatment, 6-months follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
pain disability
Time Frame: start of treatment, end of treatment, 6-months follow-up
start of treatment, end of treatment, 6-months follow-up
depression
Time Frame: start of treatment, end of treatment, 6-months folow-up
start of treatment, end of treatment, 6-months folow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philipps University Marburg Medical Center

Investigators

  • Study Chair: Winfried Rief, Professor, University Marburg, Department of Clinical Psychology and Psychotherapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

March 28, 2007

First Submitted That Met QC Criteria

March 28, 2007

First Posted (Estimate)

March 29, 2007

Study Record Updates

Last Update Posted (Actual)

October 2, 2017

Last Update Submitted That Met QC Criteria

September 27, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGT090774

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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