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NCT00454064 Clinical Trial

Cognitive-behavioural Treatment of Chronic Back Pain

Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00454064
Other study ID # RGT090774
Secondary ID
Status Completed
Phase Phase 3
First received March 28, 2007
Last updated September 27, 2017
Start date September 2004
Est. completion date February 2008

Study information
Verified date September 2017
Source Philipps University Marburg Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study:

- to compare two cognitive-behavioral treatments

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.

Recruitment information / eligibility
Status Completed
Enrollment 128
Est. completion date February 2008
Est. primary completion date September 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Back pain since 6 months

Exclusion Criteria:

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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• cognitive-behavioral treatment

Locations
Country Name City State
Germany University Marburg, Department of Clinical Psychology and Psychotherapy Marburg Hessen

Sponsors (1)
Lead Sponsor Collaborator
Philipps University Marburg Medical Center

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary pain intensity start of treatment, end of treatment, 6-months follow-up
Secondary pain disability start of treatment, end of treatment, 6-months follow-up
Secondary depression start of treatment, end of treatment, 6-months folow-up
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