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Clinical Trials/NCT00454064
NCT00454064
Completed
Phase 3

Study to Compare a Cognitive-behavioral Treatment With a Cognitive-behavioral Treatment With Biofeedback Elements to Patients With Chronic (Low) Back Pain

Philipps University Marburg Medical Center1 site in 1 country128 target enrollmentSeptember 2004
ConditionsBack Pain

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Back Pain
Sponsor
Philipps University Marburg Medical Center
Enrollment
128
Locations
1
Primary Endpoint
pain intensity
Status
Completed
Last Updated
8 years ago

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 Behavioural treatment: increasing activity levels (sports, social activities, work), reducing medication intake and unnecessary health care utilization Relaxation training: progressive muscle relaxation, biofeedback.

Registry
clinicaltrials.gov
Start Date
September 2004
End Date
February 2008
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Winfried Rief

Professor Dr.

Philipps University Marburg Medical Center

Eligibility Criteria

Inclusion Criteria

  • Back pain since 6 months

Exclusion Criteria

  • Patients with psychosis, borderline psychopathy, drug dependence i.e. alcohol

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)

Study Sites (1)

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