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

March 11, 2014 updated by: Francisco M. Kovacs, Kovacs Foundation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Throughout Spain, Spain
        • Primary care Centers affiliated with the Spanish Back Pain Research Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Degree of disability at 180 days of follow-up.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Catastrophizing and days on sick leave at 180 days of follow-up.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kovacs Foundation

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

August 4, 2006

First Submitted That Met QC Criteria

August 4, 2006

First Posted (Estimate)

August 8, 2006

Study Record Updates

Last Update Posted (Estimate)

March 13, 2014

Last Update Submitted That Met QC Criteria

March 11, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FK-R-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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