Low Back PainNCT00441038
A Trial on the Effect on Low Back Pain Related Disability of Different Health Education Programs for Retired Persons
A study testing The Back Guide, The Back Book and Cardiovascular and general health in people with Low Back Pain, run by Kovacs Foundation at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- The Back Guide, The Back Book and Cardiovascular and general health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2006to Sep 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Low Back Pain
- Being tested
- The Back Guide, The Back Book, Cardiovascular and general health
- Keywords
- Low back pain, disability, health education
- Medical subject headings
- Low Back Pain, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Back GuideBehavioural
Education on postural hygiene and handout of The Back Guide
The Back BookBehavioural
Education on active management and Handout of The Back Book
Cardiovascular and general healthBehavioural
Education on cardiovascular and general health
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Education on postural hygiene and handout of The Back Guide Receives: Behavioral: The Back Guide; Behavioral: The Back Book; Behavioral: Cardiovascular and general health |
| 2 | Active comparator | Education on active management and handout of The Back Book Receives: Behavioral: The Back Book; Behavioral: Cardiovascular and general health |
| 3 | Active comparator | Education on cardiovascular and general health Receives: Behavioral: Cardiovascular and general health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of pain, measured at baseline, 30, and 180 days
Measured: 6 months
Disability, measured at baseline, 30, and 180 days
Measured: 6 months
Secondary outcomes (2)
Fear avoidance beliefs, measured at baseline, 30, and 180 days
Measured: 6 months
Quality of life, measured at baseline, 30, and 180 days
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2007 (estimated)
- Study startDec 2006
- Primary completionJul 2008 (estimated)
- Study completionSep 2008 (estimated)
Why it stopped: Pilot study showed recruitment rates were lower than expected,and number of losses to follow-up, much higher.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kovacs Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Conseill Insular de Ibiza y Formentera, Mallorca Institute of Social Affairs
- Responsible party
- Sponsor
- Investigators
- Francisco M. Kovacs, MD, PhD, Study director, Kovacs Foundation, Palma de Mallorca, SpainJuan Noguera, MD, Principal investigator, Instituto de Asuntos Sociales y Deportes de Mallorca, Palma de Mallorca, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00441038
- Sponsor's protocol ID
- FK-R-13
- Status last verified
- Feb 2021
- First submitted
- 23 Feb 2007
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 10626311Cherkin 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.
PubMed 11322842Indahl 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.
PubMed 9854762
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Randomized Clinical Trial on the Effect on Low Back Pain Related Disability of Different Health Education Programs for Retired Persons
- ClinicalTrials.gov ID
- NCT00441038
- Acronym / sponsor ID
- FK-R-13
- Conditions
- Low Back Pain
- Keywords
- Low back pain, disability, health education
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Pilot study showed recruitment rates were lower than expected,and number of losses to follow-up, much higher.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kovacs FoundationUniversity, hospital or other
- Collaborators
- Conseill Insular de Ibiza y Formentera, Mallorca Institute of Social Affairs
- Study start
- Dec 2006
- Primary completion
- Jul 2008 (estimated)
- Study completion
- Sep 2008 (estimated)
- First posted
- 28 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: The Back Guide, Behavioral: The Back Book, Behavioral: Cardiovascular and general healthEducation on postural hygiene and handout of The Back Guide |
| 2 | Active comparator | Behavioral: The Back Book, Behavioral: Cardiovascular and general healthEducation on active management and handout of The Back Book |
| 3 | Active comparator | Behavioral: Cardiovascular and general healthEducation on cardiovascular and general health |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Back GuideEducation on postural hygiene and handout of The Back Guide | Behavioural | 1 |
| The Back BookEducation on active management and Handout of The Back Book | Behavioural | 1, 2 |
| Cardiovascular and general healthEducation on cardiovascular and general health | Behavioural | 1, 2, 3 |
Primary outcome
Intensity of pain, measured at baseline, 30, and 180 days
Time frame: 6 months
Disability, measured at baseline, 30, and 180 days
Time frame: 6 months
2 secondary outcomes
Fear avoidance beliefs, measured at baseline, 30, and 180 days
Time frame: 6 months
Quality of life, measured at baseline, 30, and 180 days
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Background: PubMed 10626311Burton 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.
- Background: PubMed 11322842Cherkin 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.
- Background: PubMed 9854762Indahl 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.
- Spanish Back Pain Research Network site that describes objectives and projects of its membersLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Back Guide, The Back Book and Cardiovascular and general health in people with Low Back Pain, run by Kovacs Foundation at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of pain, measured at baseline, 30, and 180 days (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00441038, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.