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

This study has been completed.
Sponsor:
Collaborator:
Spanish Back Pain Research Network (REIDE)
Information provided by (Responsible Party):
Francisco M. Kovacs, Kovacs Foundation
ClinicalTrials.gov Identifier:
NCT00361556
First received: August 4, 2006
Last updated: March 11, 2014
Last verified: March 2014
  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:


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
Study Completion Date: December 2012
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Spain
Primary care Centers affiliated with the Spanish Back Pain Research Network
Throughout Spain, Spain
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: Francisco M. Kovacs, Carmen Fernández, Centro de Salud de Valldargent, Kovacs Foundation
ClinicalTrials.gov Identifier: NCT00361556     History of Changes
Other Study ID Numbers: FK-R-11
Study First Received: August 4, 2006
Last Updated: March 11, 2014
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
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014