NCT00441038

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2006

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 28, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

1.6 years

First QC Date

February 23, 2007

Last Update Submit

February 22, 2021

Conditions

Low Back Pain

Keywords

Low back paindisabilityhealth education

Outcome Measures

Primary Outcomes (2)

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

    6 months

  • Disability, measured at baseline, 30, and 180 days

    6 months

Secondary Outcomes (2)

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

    6 months

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

    6 months

Study Arms (3)

1

ACTIVE COMPARATOR

Education on postural hygiene and handout of The Back Guide

Behavioral: The Back GuideBehavioral: The Back BookBehavioral: Cardiovascular and general health

2

ACTIVE COMPARATOR

Education on active management and handout of The Back Book

Behavioral: The Back BookBehavioral: Cardiovascular and general health

3

ACTIVE COMPARATOR

Education on cardiovascular and general health

Behavioral: Cardiovascular and general health

Interventions

The Back GuideBEHAVIORAL

Education on postural hygiene and handout of The Back Guide

1
The Back BookBEHAVIORAL

Education on active management and Handout of The Back Book

12
Cardiovascular and general healthBEHAVIORAL

Education on cardiovascular and general health

123

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kovacs Foundation

Palma de Mallorca, Balearic Islands, 07012, Spain

Location

Related Publications (3)

  • 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.

    PMID: 10626311BACKGROUND

  • 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.

    PMID: 11322842BACKGROUND

  • 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.

    PMID: 9854762BACKGROUND

Related Links

MeSH Terms

Conditions

Low Back PainHealth Education

Interventions

Blood CirculationHealth Status

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Cardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaDemographyPopulation CharacteristicsEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Francisco M. Kovacs, MD, PhD

    Kovacs Foundation, Palma de Mallorca, Spain

    STUDY DIRECTOR

  • Juan Noguera, MD

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

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2007

First Posted

February 28, 2007

Study Start

December 1, 2006

Primary Completion

July 1, 2008

Study Completion

September 1, 2008

Last Updated

February 24, 2021

Record last verified: 2021-02

Locations

ES(1)