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

Phase 2

Completed

• Conditions: Low Back Pain
• Interventions: Behavioral: The Back Guide; Behavioral: The Back Book; Behavioral: General health book

• Registration Number: NCT00361556
• Lead Sponsor: Kovacs Foundation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2006-08-04
• Study First Submitted QC: 2006-08-04
• Study First Posted: 2006-08-08
• Primary Completion: 2012-09
• Study Completion: 2012-12
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-11
• Last Update Posted: 2014-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	General health book	The Back Guide
3	General health book	General health book
2	The Back Guide	The Back Guide
1	The Back Book	The Back Book
1	The Back Guide	The Back Book
1	General health book	The Back Book

Primary Outcome Measures

Name	Time	Method
Degree of disability at 180 days of follow-up.	6 months

Secondary Outcome Measures

Name	Time	Method
Catastrophizing and days on sick leave at 180 days of follow-up.	6 months

Trial Locations

Locations (1)

Primary care Centers affiliated with the Spanish Back Pain Research Network; 🇪🇸 Throughout Spain, Spain