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

May 27, 2009 updated by: Kovacs Foundation
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

680

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intensity of pain, measured at baseline, 90, and 180 days later
Time Frame: 6 months
6 months
Disability, measured at baseline, 90, and 180 days later
Time Frame: 6 months
6 months
Sick leave, measured at baseline, 90, and 180 days later
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Fear avoidance beliefs, measured at baseline, 90, and 180 days later
Time Frame: 6 months
6 months
Quality of life, measured at baseline, 90, and 180 days later
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kovacs Foundation

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

February 23, 2007

First Submitted That Met QC Criteria

February 23, 2007

First Posted (Estimate)

February 26, 2007

Study Record Updates

Last Update Posted (Estimate)

May 28, 2009

Last Update Submitted That Met QC Criteria

May 27, 2009

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FK-JCL-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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