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

Primary Purpose

Low Back Pain

Status

Withdrawn

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

The Back Guide

The Back Book

Cardiovascular and general health

About this trial

This is an interventional other trial for Low Back Pain focused on measuring Low back pain, disability, health education

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Kovacs Foundation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Arm Description

Education on postural hygiene and handout of The Back Guide

Education on active management and handout of The Back Book

Education on cardiovascular and general health

Outcomes

Primary Outcome Measures

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

Disability, measured at baseline, 30, and 180 days

Secondary Outcome Measures

Fear avoidance beliefs, measured at baseline, 30, and 180 days

Quality of life, measured at baseline, 30, and 180 days

Full Information

NCT ID

NCT00441038

First Posted

February 23, 2007

Last Updated

February 22, 2021

Sponsor

Kovacs Foundation

Collaborators

Conseill Insular de Ibiza y Formentera, Mallorca Institute of Social Affairs

1. Study Identification

Unique Protocol Identification Number

NCT00441038

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Pilot study showed recruitment rates were lower than expected,and number of losses to follow-up, much higher.

Study Start Date

December 2006 (undefined)

Primary Completion Date

July 2008 (Anticipated)

Study Completion Date

September 2008 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kovacs Foundation

Collaborators

Conseill Insular de Ibiza y Formentera, Mallorca Institute of Social Affairs

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

Keywords

Low back pain, disability, health education

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Education on postural hygiene and handout of The Back Guide

Arm Title

Arm Type

Active Comparator

Arm Description

Education on active management and handout of The Back Book

Arm Title

Arm Type

Active Comparator

Arm Description

Education on cardiovascular and general health

Intervention Type

Behavioral

Intervention Name(s)

The Back Guide

Intervention Description

Education on postural hygiene and handout of The Back Guide

Intervention Type

Behavioral

Intervention Name(s)

The Back Book

Intervention Description

Education on active management and Handout of The Back Book

Intervention Type

Behavioral

Intervention Name(s)

Cardiovascular and general health

Intervention Description

Education on cardiovascular and general health

Primary Outcome Measure Information:

Title

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

Time Frame

6 months

Title

Disability, measured at baseline, 30, and 180 days

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Fear avoidance beliefs, measured at baseline, 30, and 180 days

Time Frame

6 months

Title

Quality of life, measured at baseline, 30, and 180 days

Time Frame

6 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Francisco M. Kovacs, MD, PhD

Organizational Affiliation

Kovacs Foundation, Palma de Mallorca, Spain

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Juan Noguera, MD

Organizational Affiliation

Instituto de Asuntos Sociales y Deportes de Mallorca, Palma de Mallorca, Spain

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kovacs Foundation

City

Palma de Mallorca

State/Province

Balearic Islands

ZIP/Postal Code

07012

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

10626311

Citation

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 (Phila Pa 1976). 1999 Dec 1;24(23):2484-91. doi: 10.1097/00007632-199912010-00010.

Results Reference

background

PubMed Identifier

11322842

Citation

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. doi: 10.1001/archinte.161.8.1081.

Results Reference

background

PubMed Identifier

9854762

Citation

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 (Phila Pa 1976). 1998 Dec 1;23(23):2625-30. doi: 10.1097/00007632-199812010-00018.

Results Reference

background

Links:

URL

http://www.reide.org

Description

Spanish Back Pain Research Network site that describes objectives and projects of its members

Learn more about this trial

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

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