Cognitive-behavioural Treatment of Chronic Back Pain
Primary Purpose
Back Pain
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
cognitive-behavioral treatment
Sponsored by
About this trial
This is an interventional treatment trial for Back Pain focused on measuring cognitive-behavioral therapy, back pain, low back pain, biofeedback, randomized controlled study, EMG biofeedback
Eligibility Criteria
Inclusion Criteria:
- Back pain since 6 months
Exclusion Criteria:
- Patients with psychosis, borderline psychopathy, drug dependence i.e. alcohol
Sites / Locations
- University Marburg, Department of Clinical Psychology and Psychotherapy
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
cognitive-behavioral treatment
cognitive-behavioral treatment with biofeedback elements
Outcomes
Primary Outcome Measures
pain intensity
Secondary Outcome Measures
pain disability
depression
Full Information
NCT ID
NCT00454064
First Posted
March 28, 2007
Last Updated
September 27, 2017
Sponsor
Philipps University Marburg Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00454064
Brief Title
Cognitive-behavioural Treatment of Chronic Back Pain
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 Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Philipps University Marburg Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study:
to compare two cognitive-behavioral treatments
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain
Keywords
cognitive-behavioral therapy, back pain, low back pain, biofeedback, randomized controlled study, EMG biofeedback
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
cognitive-behavioral treatment
Arm Title
2
Arm Type
Active Comparator
Arm Description
cognitive-behavioral treatment with biofeedback elements
Intervention Type
Behavioral
Intervention Name(s)
cognitive-behavioral treatment
Primary Outcome Measure Information:
Title
pain intensity
Time Frame
start of treatment, end of treatment, 6-months follow-up
Secondary Outcome Measure Information:
Title
pain disability
Time Frame
start of treatment, end of treatment, 6-months follow-up
Title
depression
Time Frame
start of treatment, end of treatment, 6-months folow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Back pain since 6 months
Exclusion Criteria:
Patients with psychosis, borderline psychopathy, drug dependence i.e. alcohol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Winfried Rief, Professor
Organizational Affiliation
University Marburg, Department of Clinical Psychology and Psychotherapy
Official's Role
Study Chair
Facility Information:
Facility Name
University Marburg, Department of Clinical Psychology and Psychotherapy
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35032
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Cognitive-behavioural Treatment of Chronic Back Pain
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