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Cognitive-behavioural Treatment of Chronic Back Pain

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ClinicalTrials.gov Identifier: NCT00454064
Recruitment Status : Completed
First Posted : March 29, 2007
Last Update Posted : October 2, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:

The purpose of the study:

  • to compare two cognitive-behavioral treatments

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

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
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
Study Start Date : September 2004
Primary Completion Date : September 2007
Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

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

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

Eligibility Criteria

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

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

University Marburg, Department of Clinical Psychology and Psychotherapy
Marburg, Hessen, Germany, 35032
Sponsors and Collaborators
Philipps University Marburg Medical Center
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 Posted: March 29, 2007    Key Record Dates
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
randomized controlled study
EMG biofeedback

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