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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
  Purpose

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.


Condition Intervention Phase
Low Back Pain
 Behavioral: The Back Book
Behavioral: The Back Guide
Behavioral: General health book
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Treatment for Nonspecific Low Back Pain in Primary Care With Standardized Health Education Booklets: A Randomized Controlled Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Further study details as provided by Kovacs Foundation:

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

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

Estimated Enrollment: 240
Study Start Date: October 2005
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
The Back Book
 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
Active Comparator: 2
The Back Guide
 Behavioral: The Back Guide
A guide for the prevention of back pain.
Behavioral: General health book
A book on general health
Active Comparator: 3
General health book
 Behavioral: General health book
A book on general health

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00361556

Contacts
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

Locations
Spain
Primary care Centers affiliated with the Spanish Back Pain Research Network Recruiting
Throughout Spain, Spain
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    
Principal Investigator: Antonio Ruiz, MD            
Principal Investigator: Carlos Isanta, MD            
Principal Investigator: Carmen Fernández, MD            
Principal Investigator: Violeta González, MD            
Principal Investigator: Pablo Panero, MD            
Principal Investigator: Margarita Gómez, MD            
Principal Investigator: Francisco Martínez, MD            
Principal Investigator: Luis González, MD            
Principal Investigator: Sergio Giménez, MD            
Sponsors and Collaborators
Kovacs Foundation
Spanish Back Pain Research Network (REIDE)
Investigators
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
  More Information

Publications:

Responsible Party: Carmen Fernández, Centro de Salud de Valldargent
ClinicalTrials.gov Identifier: NCT00361556     History of Changes
Other Study ID Numbers: FK-R-11
Study First Received: August 4, 2006
Last Updated: June 26, 2011
Health Authority: Spain: Ethics Committee

Keywords provided by Kovacs Foundation:
low back pain
disability
health education
primary care

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013