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

NCT ID: NCT00361556

Last Updated: 2014-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2012-12-31

Brief Summary

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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

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Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

The Back Book

Group Type ACTIVE_COMPARATOR

The Back Book

Intervention Type BEHAVIORAL

A book on how to prevent back pain

The Back Guide

Intervention Type BEHAVIORAL

A guide for the prevention of back pain.

General health book

Intervention Type BEHAVIORAL

A book on general health

2

The Back Guide

Group Type ACTIVE_COMPARATOR

The Back Guide

Intervention Type BEHAVIORAL

A guide for the prevention of back pain.

General health book

Intervention Type BEHAVIORAL

A book on general health

3

General health book

Group Type ACTIVE_COMPARATOR

General health book

Intervention Type BEHAVIORAL

A book on general health

Interventions

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The Back Book

A book on how to prevent back pain

Intervention Type BEHAVIORAL

The Back Guide

A guide for the prevention of back pain.

Intervention Type BEHAVIORAL

General health book

A book on general health

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spanish Back Pain Research Network (REIDE)

OTHER

Sponsor Role collaborator

Kovacs Foundation

OTHER

Sponsor Role lead

Responsible Party

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Francisco M. Kovacs

Carmen Fernández, Centro de Salud de Valldargent

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Francisco M. Kovacs, MD, PhD

Role: STUDY_CHAIR

Kovacs Foundation, Palma de Mallorca, 07012, Spain

Carmen Fernández, MD

Role: PRINCIPAL_INVESTIGATOR

Centro de Salut de Valldargent, Palma de Mallorca 07013, Spain

Antonio Ruiz, MD

Role: STUDY_DIRECTOR

Centro de Salud Las Ciudades, Madrid 28903, Spain

Carlos Isanta, MD

Role: STUDY_DIRECTOR

Centro de Salud de San José, Zaragoza 50013, Spain

Violeta González, MD

Role: STUDY_DIRECTOR

Centro de Salud Gazteleku, Bilbao 48007, Spain

Pablo Panero, MD

Role: STUDY_DIRECTOR

Centro de Salud de Órgiva, Órgiva, Granada 18400, Spain

Margarita Gómez, MD

Role: STUDY_DIRECTOR

Centro de Salud Casa del Mar, Palma de Mallorca 07012, Spain

Francisco Martínez, MD

Role: STUDY_DIRECTOR

Centro de Salud de Bembibre, Bembibre, León 24300, Spain

Luis González, MD

Role: STUDY_DIRECTOR

Centro de Salud Serrería II, Valencia 46022, Spain

Sergio Giménez, MD

Role: STUDY_DIRECTOR

Centro de Salud de Ciudad Jardín, Málaga 29017, Spain

Locations

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Primary care Centers affiliated with the Spanish Back Pain Research Network

Throughout Spain, , Spain

Site Status

Countries

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Spain

References

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Burton AK, Waddell G, Tillotson KM, Summerton N. Information and advice to patients with back pain can have a positive effect. A randomized controlled trial of a novel educational booklet in primary care. Spine (Phila Pa 1976). 1999 Dec 1;24(23):2484-91. doi: 10.1097/00007632-199912010-00010.

Reference Type BACKGROUND
PMID: 10626311 (View on PubMed)

Cherkin DC, Eisenberg D, Sherman KJ, Barlow W, Kaptchuk TJ, Street J, Deyo RA. Randomized trial comparing traditional Chinese medical acupuncture, therapeutic massage, and self-care education for chronic low back pain. Arch Intern Med. 2001 Apr 23;161(8):1081-8. doi: 10.1001/archinte.161.8.1081.

Reference Type BACKGROUND
PMID: 11322842 (View on PubMed)

Hagen EM, Eriksen HR, Ursin H. Does early intervention with a light mobilization program reduce long-term sick leave for low back pain? Spine (Phila Pa 1976). 2000 Aug 1;25(15):1973-6. doi: 10.1097/00007632-200008010-00017.

Reference Type BACKGROUND
PMID: 10908942 (View on PubMed)

Related Links

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http://www.reide.org

Spanish Back Pain Research Network site that describes objectives and projects of its members.

Other Identifiers

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FK-R-11

Identifier Type: -

Identifier Source: org_study_id

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