Cognitive-Behavioural Treatment of Chronic Back Pain
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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 |
- pain intensity [ Time Frame: start of treatment, end of treatment, 6-months follow-up ] [ Designated as safety issue: No ]
- 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 |
Inclusion Criteria:
- Back pain since 6 months
Exclusion Criteria:
- Patients with psychosis, borderline psychopathy, drug dependence i.e. alcohol
Contacts and Locations| Germany | |
| University Marburg, Department of Clinical Psychology and Psychotherapy | |
| Marburg, Hessen, Germany, 35032 | |
| 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 May 22, 2013