Brief Summary

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

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.

• Study Type: Interventional
• Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
• Study Primary Completion Date: July 2008

Interventions Used in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

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

Outcome Measures for this Clinical Trial

Primary Measures

• Intensity of pain, measured at baseline, 30, and 180 days
  • Time Frame: 6 months
    Safety Issue?: No
• Disability, measured at baseline, 30, and 180 days
  • Time Frame: 6 months
    Safety Issue?: No

Secondary Measures

• Fear avoidance beliefs, measured at baseline, 30, and 180 days
  • Time Frame: 6 months
    Safety Issue?: No
• Quality of life, measured at baseline, 30, and 180 days
  • Time Frame: 6 months
    Safety Issue?: No

Criteria for Participation in this Clinical Trial

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: Accepts Healthy Volunteers

Clinical Trial Investigator Information

• Lead Sponsor
  • Kovacs Foundation
• Collaborator
  • Conseill Insular de Ibiza y Formentera
• Provider of Information About this Clinical Study
  • Francisco M. Kovacs, Director of Scientific Department, Kovacs Foundation
• Overall Official(s)
  • Francisco M. Kovacs, MD, PhD, Study Director, Kovacs Foundation, Palma de Mallorca, Spain
  • Juan Noguera, MD, Principal Investigator, Instituto de Asuntos Sociales y Deportes de Mallorca, Palma de Mallorca, Spain

References

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. 1999 Dec 1;24(23):2484-91.

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.

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. 1998 Dec 1;23(23):2625-30.