Cognitive-behavioural Treatment of Chronic Back Pain | NCT00454064

Studies
Cognitive-behavioural Treatment of Chronic Back Pain

NCT00454064

Sponsor

Philipps University Marburg

Status

Completed

Last Update Posted

Oct 2, 2017Actual

Enrollment

128Actual

Phase

Phase 3

Conditions

Back Pain

Interventions

cognitive-behavioral treatment

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2004

Primary Completion Date

Sep 2007Actual

Completion Date

Feb 2008Actual

First Submitted Date

Mar 28, 2007

First Submission Date that Met QC Criteria

Mar 28, 2007

First Posted Date

Mar 29, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 27, 2017

Last Update Posted Date

Oct 2, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

128Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	cognitive-behavioral treatment	Behavioral: cognitive-behavioral treatment
2	Active Comparator	cognitive-behavioral treatment with biofeedback elements	Behavioral: cognitive-behavioral treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cognitive-behavioral treatment	Behavioral		1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pain intensity		start of treatment, end of treatment, 6-months follow-up

Secondary Outcomes

Measure	Description	Time Frame
pain disability		start of treatment, end of treatment, 6-months follow-up
depression		start of treatment, end of treatment, 6-months folow-up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Back pain since 6 months

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Winfried Rief, Professor	University Marburg, Department of Clinical Psychology and Psychotherapy	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Marburg, Department of Clinical Psychology and Psychotherapy		Marburg	Hesse	35032	Germany

Condition Browse Module

MeSH Terms

ID	Term
D001416	Back Pain
D017116	Low Back Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided