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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014