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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00361556
Enrollment
240
Registered
2006-08-08
Start date
2005-10-31
Completion date
2012-12-31
Last updated
2014-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

low back pain, disability, health education, primary care

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.

Interventions

BEHAVIORALThe Back Book

A book on how to prevent back pain

BEHAVIORALThe Back Guide

A guide for the prevention of back pain.

BEHAVIORALGeneral health book

A book on general health

Sponsors

Spanish Back Pain Research Network (REIDE)
CollaboratorOTHER
Kovacs Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Degree of disability at 180 days of follow-up.6 months

Secondary

MeasureTime frame
Catastrophizing and days on sick leave at 180 days of follow-up.6 months

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026