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

NCT00361556 | Completed Phase 2 DMC

• 1 other identifier: FK-R-11
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

low back pain; disability; health education; primary care

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (1)

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

  6 months

Study Arms (3)

1

ACTIVE COMPARATOR

The Back Book

Behavioral: The Back Book; Behavioral: The Back Guide; Behavioral: General health book

2

ACTIVE COMPARATOR

The Back Guide

Behavioral: The Back Guide; Behavioral: General health book

3

ACTIVE COMPARATOR

General health book

Behavioral: General health book

Interventions

The Back Book BEHAVIORAL

A book on how to prevent back pain

1

The Back Guide BEHAVIORAL

A guide for the prevention of back pain.

1; 2

General health book BEHAVIORAL

A book on general health

1; 2; 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Low back pain patients,
• with or without referred or radiated pain;
• without red flags for systemic disease or criteria for surgery.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kovacs Foundation: lead
• Spanish Back Pain Research Network (REIDE): collaborator

Study Sites (1)

Primary care Centers affiliated with the Spanish Back Pain Research Network

Throughout Spain, Spain

Location

Related 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. doi: 10.1097/00007632-199912010-00010.

  PMID: 10626311 BACKGROUND

• 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. doi: 10.1001/archinte.161.8.1081.

  PMID: 11322842 BACKGROUND

• 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. doi: 10.1097/00007632-200008010-00017.

  PMID: 10908942 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Low Back Pain; Health Education

Condition Hierarchy (Ancestors)

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

Study Officials

• Francisco M. Kovacs, MD, PhD

  Kovacs Foundation, Palma de Mallorca, 07012, Spain

  STUDY CHAIR

• Carmen Fernández, MD

  Centro de Salut de Valldargent, Palma de Mallorca 07013, Spain

  PRINCIPAL INVESTIGATOR

• Antonio Ruiz, MD

  Centro de Salud Las Ciudades, Madrid 28903, Spain

  STUDY DIRECTOR

• Carlos Isanta, MD

  Centro de Salud de San José, Zaragoza 50013, Spain

  STUDY DIRECTOR

• Violeta González, MD

  Centro de Salud Gazteleku, Bilbao 48007, Spain

  STUDY DIRECTOR

• Pablo Panero, MD

  Centro de Salud de Órgiva, Órgiva, Granada 18400, Spain

  STUDY DIRECTOR

• Margarita Gómez, MD

  Centro de Salud Casa del Mar, Palma de Mallorca 07012, Spain

  STUDY DIRECTOR

• Francisco Martínez, MD

  Centro de Salud de Bembibre, Bembibre, León 24300, Spain

  STUDY DIRECTOR

• Luis González, MD

  Centro de Salud Serrería II, Valencia 46022, Spain

  STUDY DIRECTOR

• Sergio Giménez, MD

  Centro de Salud de Ciudad Jardín, Málaga 29017, Spain

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Carmen Fernández, Centro de Salud de Valldargent

Study Record Dates

• First Submitted: August 4, 2006
• First Posted: August 8, 2006
• Study Start: October 1, 2005
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 13, 2014

Record last verified: 2014-03

Locations

ES (1)