Clinical trial NCT00361556: Treatment for Nonspecific Low Back Pain in Primary Care: a Trial on Different Health Education Booklets
Official title: Treatment for Nonspecific Low Back Pain in Primary Care With Standardized Health Education Booklets: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Low Back Pain
Keywords: low back pain
disability
health education
primary care
Lead sponsor: Kovacs Foundation
Sponsor class: OTHER
Collaborators: name: Spanish Back Pain Research Network (REIDE)
First posted: 2006-08-08
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


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.

Primary outcomes:
measure: Degree of disability at 180 days of follow-up.
timeFrame: 6 months
Secondary outcomes:
measure: Catastrophizing and days on sick leave at 180 days of follow-up.
timeFrame: 6 months
Other outcomes:
Locations:
city: Throughout Spain
country: Spain
facility: Primary care Centers affiliated with the Spanish Back Pain Research Network
Study officials:
affiliation: Kovacs Foundation, Palma de Mallorca, 07012, Spain
name: Francisco M. Kovacs, MD, PhD
role: STUDY_CHAIR
affiliation: Centro de Salut de Valldargent, Palma de Mallorca 07013, Spain
name: Carmen Fernández, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro de Salud Las Ciudades, Madrid 28903, Spain
name: Antonio Ruiz, MD
role: STUDY_DIRECTOR
affiliation: Centro de Salud de San José, Zaragoza 50013, Spain
name: Carlos Isanta, MD
role: STUDY_DIRECTOR
affiliation: Centro de Salud Gazteleku, Bilbao 48007, Spain
name: Violeta González, MD
role: STUDY_DIRECTOR
affiliation: Centro de Salud de Órgiva, Órgiva, Granada 18400, Spain
name: Pablo Panero, MD
role: STUDY_DIRECTOR
affiliation: Centro de Salud Casa del Mar, Palma de Mallorca 07012, Spain
name: Margarita Gómez, MD
role: STUDY_DIRECTOR
affiliation: Centro de Salud de Bembibre, Bembibre, León 24300, Spain
name: Francisco Martínez, MD
role: STUDY_DIRECTOR
affiliation: Centro de Salud Serrería II, Valencia 46022, Spain
name: Luis González, MD
role: STUDY_DIRECTOR
affiliation: Centro de Salud de Ciudad Jardín, Málaga 29017, Spain
name: Sergio Giménez, MD
role: STUDY_DIRECTOR
References:
citation: 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.
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. doi: 10.1001/archinte.161.8.1081.
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. doi: 10.1097/00007632-200008010-00017.