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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00361556
• Other study ID #: FK-R-11
• Status: Completed
• Phase: Phase 2
• First received: August 4, 2006
• Last updated: March 11, 2014
• Start date: October 2005
• Est. completion date: December 2012

Study information

• Verified date: March 2014
• Source: Kovacs Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Behavioral:
• The Back Book
A book on how to prevent back pain
• The Back Guide
A guide for the prevention of back pain.
• General health book
A book on general health

Locations

Country	Name	City	State
Spain	Primary care Centers affiliated with the Spanish Back Pain Research Network	Throughout Spain

Sponsors (2)

Lead Sponsor	Collaborator
Kovacs Foundation	Spanish Back Pain Research Network (REIDE)

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of disability at 180 days of follow-up.		6 months	No
Secondary	Catastrophizing and days on sick leave at 180 days of follow-up.		6 months	No

External Links

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