A Trial on the Effect on Low Back Pain Related Disability of Different Health Education Programs for Retired Persons

This study has been withdrawn prior to enrollment.
(Pilot study showed recruitment rates were lower than expected,and number of losses to follow-up, much higher.)
Sponsor:
Collaborators:
Conseill Insular de Ibiza y Formentera
Instituto de Asuntos Sociales y Deportes de Mallorca
Information provided by:
Kovacs Foundation
ClinicalTrials.gov Identifier:
NCT00441038
First received: February 23, 2007
Last updated: August 23, 2011
Last verified: August 2011
  Purpose

The primary purpose of this study is to compare, in retired persons living in the Balearic Islands, the effectiveness on low back pain related disability of three educational programs. All consist of a group talk and the handout of a booklet, each one different in its content.


Condition Intervention Phase
Low Back Pain
Behavioral: The Back Guide
Behavioral: The Back Book
Behavioral: Cardiovascular and general health
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Controlled Randomized Clinical Trial on the Effect on Low Back Pain Related Disability of Different Health Education Programs for Retired Persons

Resource links provided by NLM:


Further study details as provided by Kovacs Foundation:

Primary Outcome Measures:
  • Intensity of pain, measured at baseline, 30, and 180 days [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Disability, measured at baseline, 30, and 180 days [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fear avoidance beliefs, measured at baseline, 30, and 180 days [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Quality of life, measured at baseline, 30, and 180 days [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 1100
Study Start Date: December 2006
Estimated Study Completion Date: September 2008
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Education on postural hygiene and handout of The Back Guide
Behavioral: The Back Guide
Education on postural hygiene and handout of The Back Guide
Behavioral: The Back Book
Education on active management and Handout of The Back Book
Behavioral: Cardiovascular and general health
Education on cardiovascular and general health
Active Comparator: 2
Education on active management and handout of The Back Book
Behavioral: The Back Book
Education on active management and Handout of The Back Book
Behavioral: Cardiovascular and general health
Education on cardiovascular and general health
Active Comparator: 3
Education on cardiovascular and general health
Behavioral: Cardiovascular and general health
Education on cardiovascular and general health

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • To attend regular talks for retirees, and accept to attend one health talk, whether or not subject has nonspecific low back pain; to accept participation in the study.

Exclusion Criteria:

  • Inability to fill out questionnaires (due to blindness, functional illiteracy, or dementia);
  • Having a diagnosis of rheumatologic inflammatory disease, fibromyalgia, or cancer in last 5 years.
  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: NCT00441038

Locations
Spain
Kovacs Foundation
Palma de Mallorca, Balearic Islands, Spain, 07012
Sponsors and Collaborators
Kovacs Foundation
Conseill Insular de Ibiza y Formentera
Instituto de Asuntos Sociales y Deportes de Mallorca
Investigators
Study Director: Francisco M. Kovacs, MD, PhD Kovacs Foundation, Palma de Mallorca, Spain
Principal Investigator: Juan Noguera, MD Instituto de Asuntos Sociales y Deportes de Mallorca, Palma de Mallorca, Spain
  More Information

Publications:
Responsible Party: Francisco M. Kovacs, Director of Scientific Department, Kovacs Foundation
ClinicalTrials.gov Identifier: NCT00441038     History of Changes
Other Study ID Numbers: FK-R-13
Study First Received: February 23, 2007
Last Updated: August 23, 2011
Health Authority: Spain: Spanish Back Pain Research Network (REIDE)

Keywords provided by Kovacs Foundation:
Low back pain
disability
health education

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 20, 2014