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Cognitive-behavioural Treatment of Chronic Back Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00454064
First Posted: March 29, 2007
Last Update Posted: October 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Winfried Rief, Philipps University Marburg Medical Center
  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
Intervention Model: Parallel Assignment
Masking: None (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 Winfried Rief, Philipps University Marburg Medical Center:

Primary Outcome Measures:
  • pain intensity [ Time Frame: start of treatment, end of treatment, 6-months follow-up ]

Secondary Outcome Measures:
  • pain disability [ Time Frame: start of treatment, end of treatment, 6-months follow-up ]
  • depression [ Time Frame: start of treatment, end of treatment, 6-months folow-up ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Winfried Rief, Professor Dr., Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT00454064     History of Changes
Other Study ID Numbers: RGT090774
First Submitted: March 28, 2007
First Posted: March 29, 2007
Last Update Posted: October 2, 2017
Last Verified: September 2017

Keywords provided by Winfried Rief, 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