Cognitive-Behavioural Treatment of Chronic Back Pain

This study has been completed.
Sponsor:
Information provided by:
Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier:
NCT00454064
First received: March 28, 2007
Last updated: May 27, 2008
Last verified: May 2008
  Purpose

The purpose of the study:

  • to compare two cognitive-behavioral treatments

Condition Intervention Phase
Back Pain
Behavioral: cognitive-behavioral treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study to Compare a Cognitive-Behavioral Treatment With a Cognitive-Behavioral Treatment With Biofeedback Elements to Patients With Chronic (Low) Back Pain

Resource links provided by NLM:


Further study details as provided by Philipps University Marburg Medical Center:

Primary Outcome Measures:
  • pain intensity [ Time Frame: start of treatment, end of treatment, 6-months follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pain disability [ Time Frame: start of treatment, end of treatment, 6-months follow-up ] [ Designated as safety issue: No ]
  • depression [ Time Frame: start of treatment, end of treatment, 6-months folow-up ] [ Designated as safety issue: No ]

Enrollment: 128
Study Start Date: September 2004
Study Completion Date: February 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
cognitive-behavioral treatment
Behavioral: cognitive-behavioral treatment
Active Comparator: 2
cognitive-behavioral treatment with biofeedback elements
Behavioral: cognitive-behavioral 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Back pain since 6 months

Exclusion Criteria:

  • Patients with psychosis, borderline psychopathy, drug dependence i.e. alcohol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00454064

Locations
Germany
University Marburg, Department of Clinical Psychology and Psychotherapy
Marburg, Hessen, Germany, 35032
Sponsors and Collaborators
Philipps University Marburg Medical Center
Investigators
Study Chair: Winfried Rief, Professor University Marburg, Department of Clinical Psychology and Psychotherapy
  More Information

No publications provided

Responsible Party: Prof. Dr. Winfried Rief, Philipps University, Marburg
ClinicalTrials.gov Identifier: NCT00454064     History of Changes
Other Study ID Numbers: RGT090774
Study First Received: March 28, 2007
Last Updated: May 27, 2008
Health Authority: Germany: Ethics Commission

Keywords provided by Philipps University Marburg Medical Center:
cognitive-behavioral therapy
back pain
low back pain
biofeedback
randomized controlled study
EMG biofeedback

Additional relevant MeSH terms:
Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014