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This study has been withdrawn prior to enrollment.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

Tracking Information

First Received Date ^ICMJE

February 23, 2007

Last Updated Date

August 23, 2011

Start Date ^ICMJE

December 2006

Estimated Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Intensity of pain, measured at baseline, 30, and 180 days
Disability, measured at baseline, 30, and 180 days

Change History

Complete list of historical versions of study NCT00441038 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Fear avoidance beliefs, measured at baseline, 30, and 180 days
Quality of life, measured at baseline, 30, and 180 days

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)

Condition ^ICMJE

Low Back Pain

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: 1
Education on postural hygiene and handout of The Back Guide
Interventions:
- Behavioral: The Back Guide
- Behavioral: The Back Book
- Behavioral: Cardiovascular and general health
Active Comparator: 2
Education on active management and handout of The Back Book
Interventions:
- Behavioral: The Back Book
- Behavioral: Cardiovascular and general health
Active Comparator: 3
Education on cardiovascular and general health

Intervention: Behavioral: Cardiovascular and general health

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

1100

Estimated Completion Date

September 2008

Estimated Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Spain

Administrative Information

NCT Number ^ICMJE

NCT00441038

Other Study ID Numbers ^ICMJE

FK-R-13

Has Data Monitoring Committee

Yes

Responsible Party

Francisco M. Kovacs, Director of Scientific Department, Kovacs Foundation

Study Sponsor ^ICMJE

Kovacs Foundation

Collaborators ^ICMJE

Conseill Insular de Ibiza y Formentera
Instituto de Asuntos Sociales y Deportes de Mallorca

Investigators ^ICMJE

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

Information Provided By

Kovacs Foundation

Verification Date

August 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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