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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00439764
Recruitment Status : Completed
First Posted : February 26, 2007
Last Update Posted : May 28, 2009
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Low Back Pain Behavioral: General health talk Behavioral: Handout of The Back Book Behavioral: Back exercise Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 680 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Health Education vs. Health Education Plus Physical Therapy for Low Back Pain Patients
Study Start Date : March 2007
Primary Completion Date : August 2008
Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Intensity of pain, measured at baseline, 90, and 180 days later [ Time Frame: 6 months ]
  2. Disability, measured at baseline, 90, and 180 days later [ Time Frame: 6 months ]
  3. Sick leave, measured at baseline, 90, and 180 days later [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Fear avoidance beliefs, measured at baseline, 90, and 180 days later [ Time Frame: 6 months ]
  2. Quality of life, measured at baseline, 90, and 180 days later [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications:
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
First Posted: February 26, 2007    Key Record Dates
Last Update Posted: May 28, 2009
Last Verified: November 2008

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