The Effect of Two Short Education Programs for Nonspecific Low Back Pain in a Workers' Health Care Organization

NCT00665821 | Terminated DMC

• 1 other identifier: FK-S-24
• Study Type: interventional
• Target: 657
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Low Back Pain

Keywords

nonspecific low back pain; disability; sick leave; catastrophizing; workers

Outcome Measures

Primary Outcomes (1)

• A reduction in low back pain related disability and sick leave.

  365 days

Secondary Outcomes (1)

• A reduction in catastrophizing beliefs related to low back pain.

  365 days

Interventions

Classic back pain prevention education, and cognitive behavioral management. BEHAVIORAL

Classic education: postural hygiene, Back Guide. Cognitive behavioral management: active management, Back Book.

General health education BEHAVIORAL

General health education: a booklet describing general norms for maintaining good health

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• low back pain patients, with or without referred or radiated pain
• no systemic disease or criteria for referral to surgery

You may not qualify if:

• inability to fill out the questionnaires and scales
• bedridden
• rheumatologic inflammatory disease, cancer or fibromyalgia
• suspicion of fibromyalgia
• spinal fracture

Sponsors & Collaborators

• Kovacs Foundation: lead
• Hospital Laboral SOLIMAT: collaborator

Study Sites (2)

Kovacs Foundation

Palma de Mallorca, Balearic Islands, 07012, Spain

Location

Hospital Laboral SOLIMAT

Toledo, Castille-La Mancha, 45004, 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: 10626311 BACKGROUND

• 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. doi: 10.1136/bmj.38216.868808.7C. Epub 2004 Sep 17.

  PMID: 15377573 BACKGROUND

• Kovacs F, Abraira V, Santos S, Diaz 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. doi: 10.1097/01.brs.0000261556.84266.0f.

  PMID: 17471084 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Francisco M Kovacs, MD, PhD

  Kovacs Foundation, Palma de Mallorca, 07012, Spain

  STUDY DIRECTOR

• Andrés Barriga, MD

  Hospital Laboral Solimat, Toledo, Spain

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 23, 2008
• First Posted: April 24, 2008
• Study Start: September 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: February 1, 2011
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

ES (2)