Back to resultsThe Effect of Two Short Education Programs for Nonspecific Low Back Pain in a Workers' Health Care Organization
Primary Purpose
Low Back Pain
Status
Terminated
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Classic back pain prevention education, and cognitive behavioral management.
General health education
Sponsored by
About this trial
This is an interventional other trial for Low Back Pain focused on measuring nonspecific low back pain, disability, sick leave, catastrophizing, workers
Eligibility Criteria
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
Sites / Locations
- Kovacs Foundation
- Hospital Laboral SOLIMAT
Outcomes
Primary Outcome Measures
A reduction in low back pain related disability and sick leave.
Secondary Outcome Measures
A reduction in catastrophizing beliefs related to low back pain.
Full Information
NCT ID
NCT00665821
First Posted
April 23, 2008
Last Updated
August 22, 2019
Sponsor
Kovacs Foundation
Collaborators
Hospital Laboral SOLIMAT
1. Study Identification
Unique Protocol Identification Number
NCT00665821
Brief Title
The Effect of Two Short Education Programs for Nonspecific Low Back Pain in a Workers' Health Care Organization
Official Title
Study of the Effect of Two Short Education Programs for the Treatment of Nonspecific Low Back Pain in Patients Seen at a Workers' Health Care Organization
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
From Sept./08 to April/09 only 30 subjects were recruited. It has proved extremely difficult to recruit subjects.
Study Start Date
September 2008 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kovacs Foundation
Collaborators
Hospital Laboral SOLIMAT
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
nonspecific low back pain, disability, sick leave, catastrophizing, workers
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
657 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Classic back pain prevention education, and cognitive behavioral management.
Intervention Description
Classic education: postural hygiene, Back Guide. Cognitive behavioral management: active management, Back Book.
Intervention Type
Behavioral
Intervention Name(s)
General health education
Intervention Description
General health education: a booklet describing general norms for maintaining good health
Primary Outcome Measure Information:
Title
A reduction in low back pain related disability and sick leave.
Time Frame
365 days
Secondary Outcome Measure Information:
Title
A reduction in catastrophizing beliefs related to low back pain.
Time Frame
365 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco M Kovacs, MD, PhD
Organizational Affiliation
Kovacs Foundation, Palma de Mallorca, 07012, Spain
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Andrés Barriga, MD
Organizational Affiliation
Hospital Laboral Solimat, Toledo, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kovacs Foundation
City
Palma de Mallorca
State/Province
Balearic Islands
ZIP/Postal Code
07012
Country
Spain
Facility Name
Hospital Laboral SOLIMAT
City
Toledo
State/Province
Castilla La Mancha
ZIP/Postal Code
45004
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
10626311
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.
Results Reference
background
PubMed Identifier
15377573
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. doi: 10.1136/bmj.38216.868808.7C. Epub 2004 Sep 17.
Results Reference
background
PubMed Identifier
17471084
Citation
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.
Results Reference
background
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The Effect of Two Short Education Programs for Nonspecific Low Back Pain in a Workers' Health Care Organization
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