Treatment for Nonspecific Low Back Pain in Primary Care: a Trial on Different Health Education Booklets

This study is currently recruiting participants.

Verified June 2011 by Kovacs Foundation

Sponsor:

Collaborator:

Spanish Back Pain Research Network (REIDE)

Information provided by:

Kovacs Foundation

ClinicalTrials.gov Identifier:

NCT00361556

First received: August 4, 2006

Last updated: June 26, 2011

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

August 4, 2006

Last Updated Date

June 26, 2011

Start Date ^ICMJE

October 2005

Estimated Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Degree of disability at 180 days of follow-up. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Degree of disability at 180 days of follow-up.

Change History

Complete list of historical versions of study NCT00361556 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Catastrophizing and days on sick leave at 180 days of follow-up. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Catastrophizing and days on sick leave at 180 days of follow-up.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Treatment for Nonspecific Low Back Pain in Primary Care: a Trial on Different Health Education Booklets

Official Title ^ICMJE

Treatment for Nonspecific Low Back Pain in Primary Care With Standardized Health Education Booklets: A Randomized Controlled Clinical Trial

Brief Summary

The primary purpose of this study is to compare the effectiveness on the disability of low back pain patients of The Back Book, The Back Guide, and a control intervention (generic recommendations on general health). Patients are divided into 3 groups:those who receive The Back Book (classic education), those who receive The Back Guide (cognitive behavioral education) and the control group). They are patients who consult a physician at the primary care consults of 14 different Health Centers in Spain. The sample size is 240 subjects.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)

Condition ^ICMJE

Low Back Pain

Intervention ^ICMJE

Behavioral: The Back Book
A book on how to prevent back pain
Behavioral: The Back Guide
A guide for the prevention of back pain.
Behavioral: General health book
A book on general health

Study Arm (s)

Active Comparator: 1
The Back Book
Interventions:
- Behavioral: The Back Book
- Behavioral: The Back Guide
- Behavioral: General health book
Active Comparator: 2
The Back Guide
Interventions:
- Behavioral: The Back Guide
- Behavioral: General health book
Active Comparator: 3
General health book

Intervention: Behavioral: General health book

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

240

Estimated Completion Date

December 2012

Estimated Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Low back pain patients,
with or without referred or radiated pain;
without red flags for systemic disease or criteria for surgery.

Exclusion Criteria:

Inability to read the handout or to fill out the questionnaires;
habitually in a prostrate position;
diagnosis of inflammatory rheumatologic disease, cancer or fibromyalgia; suspicion of fibromyalgia.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Francisco M. Kovacs, MD, PhD	+34 971 720809	kovacs@kovacs.org
Contact: María Teresa Gil del Real, MPH	+34 91 3440244	mtgildelreal@kovacs.org

Location Countries ^ICMJE

Spain

Administrative Information

NCT Number ^ICMJE

NCT00361556

Other Study ID Numbers ^ICMJE

FK-R-11

Has Data Monitoring Committee

Yes

Responsible Party

Carmen Fernández, Centro de Salud de Valldargent

Study Sponsor ^ICMJE

Kovacs Foundation

Collaborators ^ICMJE

Spanish Back Pain Research Network (REIDE)

Investigators ^ICMJE

Study Chair:	Francisco M. Kovacs, MD, PhD	Kovacs Foundation, Palma de Mallorca, 07012, Spain
Principal Investigator:	Carmen Fernández, MD	Centro de Salut de Valldargent, Palma de Mallorca 07013, Spain
Study Director:	Antonio Ruiz, MD	Centro de Salud Las Ciudades, Madrid 28903, Spain
Study Director:	Carlos Isanta, MD	Centro de Salud de San José, Zaragoza 50013, Spain
Study Director:	Violeta González, MD	Centro de Salud Gazteleku, Bilbao 48007, Spain
Study Director:	Pablo Panero, MD	Centro de Salud de Órgiva, Órgiva, Granada 18400, Spain
Study Director:	Margarita Gómez, MD	Centro de Salud Casa del Mar, Palma de Mallorca 07012, Spain
Study Director:	Francisco Martínez, MD	Centro de Salud de Bembibre, Bembibre, León 24300, Spain
Study Director:	Luis González, MD	Centro de Salud Serrería II, Valencia 46022, Spain
Study Director:	Sergio Giménez, MD	Centro de Salud de Ciudad Jardín, Málaga 29017, Spain

Information Provided By

Kovacs Foundation

Verification Date

June 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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