Cognitive-behavioural Treatment of Chronic Back Pain

Phase 3

Completed

• Conditions: Back Pain
• Interventions: Behavioral: cognitive-behavioral treatment

• Registration Number: NCT00454064
• Lead Sponsor: Philipps University Marburg Medical Center

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.

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2007-03-28
• Study First Submitted QC: 2007-03-28
• Study First Posted: 2007-03-29
• Primary Completion: 2007-09
• Study Completion: 2008-02
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-27
• Last Update Posted: 2017-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• Back pain since 6 months

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	cognitive-behavioral treatment	cognitive-behavioral treatment
2	cognitive-behavioral treatment	cognitive-behavioral treatment with biofeedback elements

Primary Outcome Measures

Name	Time	Method
pain intensity	start of treatment, end of treatment, 6-months follow-up

Secondary Outcome Measures

Name	Time	Method
depression	start of treatment, end of treatment, 6-months folow-up
pain disability	start of treatment, end of treatment, 6-months follow-up

Trial Locations

Locations (1)

University Marburg, Department of Clinical Psychology and Psychotherapy; 🇩🇪 Marburg, Hessen, Germany