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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00665821
Other study ID # FK-S-24
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 2008
Est. completion date February 2011

Study information

Verified date August 2019
Source Kovacs Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the effect of two different types of health education programs on the disability, beliefs related to low back pain and duration of sick leave in patients seen at a workers' health care organization


Recruitment information / eligibility

Status Terminated
Enrollment 657
Est. completion date February 2011
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- low back pain patients, with or without referred or radiated pain

- no systemic disease or criteria for referral to surgery

Exclusion Criteria:

- inability to fill out the questionnaires and scales

- bedridden

- rheumatologic inflammatory disease, cancer or fibromyalgia

- suspicion of fibromyalgia

- spinal fracture

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Classic back pain prevention education, and cognitive behavioral management.
Classic education: postural hygiene, Back Guide. Cognitive behavioral management: active management, Back Book.
General health education
General health education: a booklet describing general norms for maintaining good health

Locations

Country Name City State
Spain Kovacs Foundation Palma de Mallorca Balearic Islands
Spain Hospital Laboral SOLIMAT Toledo Castilla La Mancha

Sponsors (2)

Lead Sponsor Collaborator
Kovacs Foundation Hospital Laboral SOLIMAT

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

Frost H, Lamb SE, Doll HA, Carver PT, Stewart-Brown S. Randomised controlled trial of physiotherapy compared with advice for low back pain. BMJ. 2004 Sep 25;329(7468):708. Epub 2004 Sep 17. — View Citation

Kovacs F, Abraira V, Santos S, Díaz E, Gestoso M, Muriel A, Gil del Real MT, Mufraggi N, Noguera J, Zamora J; Spanish Back Pain Research Network. A comparison of two short education programs for improving low back pain-related disability in the elderly: a cluster randomized controlled trial. Spine (Phila Pa 1976). 2007 May 1;32(10):1053-9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary A reduction in low back pain related disability and sick leave. 365 days
Secondary A reduction in catastrophizing beliefs related to low back pain. 365 days
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