NCT00454064

Brief Summary

The purpose of the study:

  • to compare two cognitive-behavioral treatments

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2004

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 29, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

October 2, 2017

Status Verified

September 1, 2017

Enrollment Period

3 years

First QC Date

March 28, 2007

Last Update Submit

September 27, 2017

Conditions

Back Pain

Keywords

cognitive-behavioral therapyback painlow back painbiofeedbackrandomized controlled studyEMG biofeedback

Outcome Measures

Primary Outcomes (1)

  • pain intensity

    start of treatment, end of treatment, 6-months follow-up

Secondary Outcomes (2)

  • pain disability

    start of treatment, end of treatment, 6-months follow-up

  • depression

    start of treatment, end of treatment, 6-months folow-up

Study Arms (2)

1

ACTIVE COMPARATOR

cognitive-behavioral treatment

Behavioral: cognitive-behavioral treatment

2

ACTIVE COMPARATOR

cognitive-behavioral treatment with biofeedback elements

Behavioral: cognitive-behavioral treatment

Interventions

cognitive-behavioral treatmentBEHAVIORAL
12

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Back pain since 6 months

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Marburg, Department of Clinical Psychology and Psychotherapy

Marburg, Hesse, 35032, Germany

Location

MeSH Terms

Conditions

Back PainLow Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Winfried Rief, Professor

    University Marburg, Department of Clinical Psychology and Psychotherapy

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr.

Study Record Dates

First Submitted

March 28, 2007

First Posted

March 29, 2007

Study Start

September 1, 2004

Primary Completion

September 1, 2007

Study Completion

February 1, 2008

Last Updated

October 2, 2017

Record last verified: 2017-09

Locations

DE(1)