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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00441038
Other study ID # FK-R-13
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date December 2006
Est. completion date September 2008

Study information

Verified date February 2021
Source Kovacs Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 2008
Est. primary completion date July 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
The Back Guide
Education on postural hygiene and handout of The Back Guide
The Back Book
Education on active management and Handout of The Back Book
Cardiovascular and general health
Education on cardiovascular and general health

Locations

Country Name City State
Spain Kovacs Foundation Palma de Mallorca Balearic Islands

Sponsors (3)

Lead Sponsor Collaborator
Kovacs Foundation Conseill Insular de Ibiza y Formentera, Mallorca Institute of Social Affairs

Country where clinical trial is conducted

Spain, 

References & 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. — View 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. — View Citation

Indahl A, Haldorsen EH, Holm S, Reikerås 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Intensity of pain, measured at baseline, 30, and 180 days 6 months
Primary Disability, measured at baseline, 30, and 180 days 6 months
Secondary Fear avoidance beliefs, measured at baseline, 30, and 180 days 6 months
Secondary Quality of life, measured at baseline, 30, and 180 days 6 months
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