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OpenTrials
Completed

NCT Number: NCT00361556

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

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.

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Key information

Conditions

Low Back Pain Adherence Interventions Back Pain Behavior Health Behavior Health Education Medication Adherence Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Signs and Symptoms Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Primary care Centers affiliated with the Spanish Back Pain Research Network

Throughout Spain, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The Back Book

Behavioral

A book on how to prevent back pain

The Back Guide

Behavioral

A guide for the prevention of back pain.

General health book

Behavioral

A book on general health

Primary outcomes

  1. Degree of disability at 180 days of follow-up.

    Time frame: 6 months

Secondary outcomes

  1. Catastrophizing and days on sick leave at 180 days of follow-up.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Kovacs Foundation

Other

Collaborators

  • Spanish Back Pain Research Network (REIDE)

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2012
Study completion
2012
First posted
Aug 8, 2006
Registry last updated
Mar 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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