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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 22, 2014