Health Education vs. Health Education Plus Physical Therapy for Low Back Pain Patients

This study has been completed.
Sponsor:
Collaborator:
Consejería de Sanidad, Junta de Castilla y León
Information provided by:
Kovacs Foundation
ClinicalTrials.gov Identifier:
NCT00439764
First received: February 23, 2007
Last updated: May 27, 2009
Last verified: November 2008
  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:


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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 April 23, 2014