Study to Compare a Cognitive-behavioral Treatment With a Cognitive-behavioral Treatment With Biofeedback Elements to Patients With Chronic (Low) Back Pain
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 128
- Locations
- 2
- Primary Endpoint
- pain intensity
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Back pain since 6 months
Exclusion Criteria
- •Patients with psychosis, borderline psychopathy, drug dependence i.e. alcohol
Arms & Interventions
1
cognitive-behavioral treatment
Intervention: cognitive-behavioral treatment (Behavioral)
2
cognitive-behavioral treatment with biofeedback elements
Intervention: cognitive-behavioral treatment (Behavioral)
Outcomes
Primary Outcomes
pain intensity
Time Frame: start of treatment, end of treatment, 6-months follow-up
Secondary Outcomes
- depression(start of treatment, end of treatment, 6-months folow-up)
- pain disability(start of treatment, end of treatment, 6-months follow-up)
Investigators
Winfried Rief
Professor Dr.
Philipps University Marburg Medical Center