Health Education vs. Health Education Plus Physical Therapy for Low Back Pain Patients - Full Text View

Purpose

The primary purpose of this study is to assess the effectiveness of a brief educational program and of an additional program in physical therapy, for the treatment of low back pain in Primary Care of the Spanish National Health Service. This is a controlled, cluster randomized community trial.

Condition	Intervention	Phase
Low Back Pain	Behavioral: General health talk Behavioral: Handout of The Back Book Behavioral: Back exercise	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Health Education vs. Health Education Plus Physical Therapy for Low Back Pain Patients

Resource links provided by NLM:

MedlinePlus related topics: Back Pain Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by Kovacs Foundation:

Primary Outcome Measures:

Intensity of pain, measured at baseline, 90, and 180 days later [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Disability, measured at baseline, 90, and 180 days later [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Sick leave, measured at baseline, 90, and 180 days later [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Fear avoidance beliefs, measured at baseline, 90, and 180 days later [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Quality of life, measured at baseline, 90, and 180 days later [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	680
Study Start Date:	March 2007
Study Completion Date:	September 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Routine clinical practice and talk on general health	Behavioral: General health talk Routine clinical practice and talk on general health Behavioral: Handout of The Back Book Talk on health of the back and handout of The Back Book Behavioral: Back exercise Routine clinical practice, talk on back health, handout of The Back Book and back exercise
Active Comparator: 2 Talk on back health and handout of The Back Book	Behavioral: Handout of The Back Book Talk on health of the back and handout of The Back Book Behavioral: Back exercise Routine clinical practice, talk on back health, handout of The Back Book and back exercise
Active Comparator: 3 Routine clinical practice, talk on back health, handout of The Back Book and back exercise	Behavioral: Back exercise Routine clinical practice, talk on back health, handout of The Back Book and back exercise

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Consultation for low back pain, with or without referred or radiated pain; no signs of systemic disease or criteria for surgery.

Exclusion Criteria:

Inability to fill out the questionnaires (blindness, dementia, illiteracy; total habitual prostration;
Diagnosis of rheumatologic inflammatory disease, fibromyalgia or cancer in last 5 years;
Suspicion of fibromyalgia.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00439764

Locations

Spain
Servicio de Atención Primaria del SACYL
Valladolid, Castilla y León, Spain, 47005

Sponsors and Collaborators

Kovacs Foundation

Consejería de Sanidad, Junta de Castilla y León

Investigators

Study Chair:	Francisco M Kovacs, MD, PhD	Kovacs Foundation, Palma de Mallorca, 07012, Spain
Study Director:	Celia Albaladejo, MD	Consejería de Sanidad, 47071 Valladolid, Spain
Principal Investigator:	Rafael del Pino, PT	Centro de Especialidades de Fisioterapia, 47014 Valladolid, Spain

More Information

Publications:

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. 1999 Dec 1;24(23):2484-91.

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.

Frost H, Lamb SE, Doll HA, Carver PT, Stewart-Brown S. Randomised controlled trial of physiotherapy compared with advice for low back pain. BMJ. 2004 Sep 25;329(7468):708. Epub 2004 Sep 17.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Albaladejo C, Kovacs FM, Royuela A, del Pino R, Zamora J; Spanish Back Pain Research Network. The efficacy of a short education program and a short physiotherapy program for treating low back pain in primary care: a cluster randomized trial. Spine (Phila Pa 1976). 2010 Mar 1;35(5):483-96.

Responsible Party:	Celia Albaladejo, Dirección General de Salud Pública y Consumo, Consejería de Sanidad, Junta de Castilla y León
ClinicalTrials.gov Identifier:	NCT00439764 History of Changes
Other Study ID Numbers:	FK-JCL-14
Study First Received:	February 23, 2007
Last Updated:	May 27, 2009
Health Authority:	Spain: Consejería de Sanidad, Junta de Castilla y León; Spain: Spanish Back Pain Research Network (REIDE)

Keywords provided by Kovacs Foundation:

Low back pain, health education, physical therapy

Additional relevant MeSH terms:

Back Pain
Low Back Pain
Pain

Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013