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

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ClinicalTrials.gov Identifier: NCT00441038
Recruitment Status : Withdrawn (Pilot study showed recruitment rates were lower than expected,and number of losses to follow-up, much higher.)
First Posted : February 28, 2007
Last Update Posted : August 24, 2011
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Low Back Pain Behavioral: The Back Guide Behavioral: The Back Book Behavioral: Cardiovascular and general health Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Controlled Randomized Clinical Trial on the Effect on Low Back Pain Related Disability of Different Health Education Programs for Retired Persons
Study Start Date : December 2006
Estimated Primary Completion Date : July 2008
Estimated Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Intensity of pain, measured at baseline, 30, and 180 days [ Time Frame: 6 months ]
  2. Disability, measured at baseline, 30, and 180 days [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Fear avoidance beliefs, measured at baseline, 30, and 180 days [ Time Frame: 6 months ]
  2. Quality of life, measured at baseline, 30, and 180 days [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

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): NCT00441038


Locations
Spain
Kovacs Foundation
Palma de Mallorca, Balearic Islands, Spain, 07012
Sponsors and Collaborators
Kovacs Foundation
Conseill Insular de Ibiza y Formentera
Mallorca Institute of Social Affairs
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