Clinical trial NCT00441038: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Low Back Pain
Keywords: Low back pain
disability
health education
Lead sponsor: Kovacs Foundation
Sponsor class: OTHER
Collaborators: name: Conseill Insular de Ibiza y Formentera
name: Mallorca Institute of Social Affairs
First posted: 2007-02-28
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Intensity of pain, measured at baseline, 30, and 180 days
timeFrame: 6 months
measure: Disability, measured at baseline, 30, and 180 days
timeFrame: 6 months
Secondary outcomes:
measure: Fear avoidance beliefs, measured at baseline, 30, and 180 days
timeFrame: 6 months
measure: Quality of life, measured at baseline, 30, and 180 days
timeFrame: 6 months
Other outcomes:
Locations:
city: Palma de Mallorca
country: Spain
facility: Kovacs Foundation
state: Balearic Islands
Study officials:
affiliation: Kovacs Foundation, Palma de Mallorca, Spain
name: Francisco M. Kovacs, MD, PhD
role: STUDY_DIRECTOR
affiliation: Instituto de Asuntos Sociales y Deportes de Mallorca, Palma de Mallorca, Spain
name: Juan Noguera, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.