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

Kovacs Foundation1 site in 1 country240 target enrollmentOctober 2005

ConditionsLow Back Pain

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Low Back Pain
Sponsor: Kovacs Foundation
Enrollment: 240
Locations: 1
Primary Endpoint: Degree of disability at 180 days of follow-up.
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2005

End Date

December 2012

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Kovacs Foundation

Responsible Party

Principal Investigator

Francisco M. Kovacs

Carmen Fernández, Centro de Salud de Valldargent

Kovacs Foundation

Eligibility 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.