A Trial on the Effect on Low Back Pain Related Disability of Different Health Education Programs for Retired Persons
February 22, 2021 updated by: Kovacs Foundation
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 Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Balearic Islands
-
Palma de Mallorca, Balearic Islands, Spain, 07012
- Kovacs Foundation
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: 1
Education on postural hygiene and handout of The Back Guide
|
Education on postural hygiene and handout of The Back Guide
Education on active management and Handout of The Back Book
Education on cardiovascular and general health
|
|
ACTIVE_COMPARATOR: 2
Education on active management and handout of The Back Book
|
Education on active management and Handout of The Back Book
Education on cardiovascular and general health
|
|
ACTIVE_COMPARATOR: 3
Education on cardiovascular and general health
|
Education on cardiovascular and general health
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Intensity of pain, measured at baseline, 30, and 180 days
Time Frame: 6 months
|
6 months
|
|
Disability, measured at baseline, 30, and 180 days
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Fear avoidance beliefs, measured at baseline, 30, and 180 days
Time Frame: 6 months
|
6 months
|
|
Quality of life, measured at baseline, 30, and 180 days
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Francisco M. Kovacs, MD, PhD, Kovacs Foundation, Palma de Mallorca, Spain
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Primary Completion (ANTICIPATED)
July 1, 2008
Study Completion (ANTICIPATED)
September 1, 2008
Study Registration Dates
First Submitted
February 23, 2007
First Submitted That Met QC Criteria
February 27, 2007
First Posted (ESTIMATE)
February 28, 2007
Study Record Updates
Last Update Posted (ACTUAL)
February 24, 2021
Last Update Submitted That Met QC Criteria
February 22, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FK-R-13
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.