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This study has been withdrawn prior to enrollment.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

History of Changes

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:

MedlinePlus related topics: Back Pain

U.S. FDA Resources

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

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:

Burton AK, Waddell G, Tillotson KM, Summerton N. Information and advice to patients with back pain can have a positive effect. A randomized controlled trial of a novel educational booklet in primary care. Spine. 1999 Dec 1;24(23):2484-91.

Cherkin DC, Eisenberg D, Sherman KJ, Barlow W, Kaptchuk TJ, Street J, Deyo RA. Randomized trial comparing traditional Chinese medical acupuncture, therapeutic massage, and self-care education for chronic low back pain. Arch Intern Med. 2001 Apr 23;161(8):1081-8.

Indahl A, Haldorsen EH, Holm S, Reikeras O, Ursin H. Five-year follow-up study of a controlled clinical trial using light mobilization and an informative approach to low back pain. Spine. 1998 Dec 1;23(23):2625-30.

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
Pain

Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013

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