Low Back PainNCT00809640
Active Management for Low Back Pain for 6 to 8 Year Old Schoolchildren
A study testing Education (Back Comic-Book) in people with Low Back Pain, run by Kovacs Foundation at 1 site in Spain.
Trial summary
The objective is to assess the effectiveness of a prevention campaign promoting active management in shifting beliefs in 6 to 8 year old schoolchildren. Subjects will be taken from a random sample of schools in Majorca, Spain: private, public and concerted. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Education (Back Comic-Book)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2009to Jun 2009
- 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 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Students in randomly selected private, public and concerted Majorca schools
- Must be present in class on day of intervention and assessments
Who cannot join
- Absent from class on day of intervention and assessments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Active Management for Low Back Pain Taught to 6 to 8 Year Old Schoolchildren
The objective is to assess the effectiveness of a prevention campaign promoting active management in shifting beliefs in 6 to 8 year old schoolchildren. Subjects will be taken from a random sample of schools in Majorca, Spain: private, public and concerted. A 10 item questionnaire will be given to all children in that age group, to be answered in class on days 1, 14 and 97. Schools will be randomly assigned to the study and control groups. In the study group the students will get a Back Comic-Book (promotes active management) after the first assessment. The control group will have no other intervention than the questionnaire.
- Conditions
- Low Back Pain
- Being tested
- Education (Back Comic-Book)
- Keywords
- low back pain, prevention, schoolchildren, education campaign
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education (Back Comic-Book)Behavioural
Through the Back Comic-Book the schoolchildren are taught prevention methods for low back pain.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | The intervention group will receive prevention of low back pain education through a Back Comic-Book, and their beliefs/knowledge will be tested twice after intervention. Receives: Behavioral: Education (Back Comic-Book) |
| 2 | No intervention | The control group will receive no intervention, and their beliefs/knowledge on low back pain will be tested twice after the first assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the effectiveness of a prevention campaign promoting active management of low back pain in shifting beliefs in 6 to 8 year old schoolchildren.
Measured: 4 months
Assessment of the effectiveness of a prevention campaign promoting active management on low back pain in 6 to 8 year old schoolchildren.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startFeb 2009
- Primary completionMay 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kovacs Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Francisco M Kovacs, MD, PhD, Study director, Kovacs Foundation, Palma de Mallorca, 07012, SpainMario Gestoso, MD, Principal investigator, Kovacs Foundation,Palma de Mallorca, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809640
- Sponsor's protocol ID
- FK 27
- Status last verified
- Dec 2009
- First submitted
- 15 Dec 2008
- Last updated
- 7 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Management for Low Back Pain Taught to 6 to 8 Year Old Schoolchildren
- ClinicalTrials.gov ID
- NCT00809640
- Acronym / sponsor ID
- FK 27
- Conditions
- Low Back Pain
- Keywords
- low back pain, prevention, schoolchildren, education campaign
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Kovacs FoundationUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- May 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 17 Dec 2008 (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 objective is to assess the effectiveness of a prevention campaign promoting active management in shifting beliefs in 6 to 8 year old schoolchildren. Subjects will be taken from a random sample of schools in Majorca, Spain: private, public and concerted. A 10 item questionnaire will be given to all children in that age group, to be answered in class on days 1, 14 and 97. Schools will be randomly assigned to the study and control groups. In the study group the students will get a Back Comic-Book (promotes active management) after the first assessment. The control group will have no other intervention than the questionnaire.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Education (Back Comic-Book)The intervention group will receive prevention of low back pain education through a Back Comic-Book, and their beliefs/knowledge will be tested twice after intervention. |
| 2 | No intervention | –The control group will receive no intervention, and their beliefs/knowledge on low back pain will be tested twice after the first assessment. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Students in randomly selected private, public and concerted Majorca schools
- Must be present in class on day of intervention and assessments
Key exclusion criteria (1 listed)
- Absent from class on day of intervention and assessments
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 |
|---|---|---|
| Education (Back Comic-Book)Through the Back Comic-Book the schoolchildren are taught prevention methods for low back pain. | Behavioural | 1 |
Primary outcome
Assessment of the effectiveness of a prevention campaign promoting active management of low back pain in shifting beliefs in 6 to 8 year old schoolchildren.
Time frame: 4 months
Assessment of the effectiveness of a prevention campaign promoting active management on low back pain in 6 to 8 year old schoolchildren.
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2009.
Related trials for Low Back Pain
Not yet recruiting
Pilot Study: Clinical Trial of Ultrasound Guiding Pharmacopuncture Therapy for Acute Low Back Pain
Low Back Pain (LBP)
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
RecruitingObservational study
The Hidden Burden of Cerebral Palsy: Exploring the Relationship Between Gross Motor Function of Children, Maternal Low Back Pain, and Quality of Life
Gross Motor
Not yet recruiting
Comparison of Two Patient Education Methods in Women With Chronic Low Back Pain: Online Pain Education vs. AI-Driven Patient Education on Pain Beliefs, Catastrophizing, and Self-Efficacy
Chronic Low Back Pain (CLBP)
Not yet recruiting
Effects of Myofascial Techniques on Chronic Low Back Pain
Chronic Low-back Pain (cLBP)
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, 07012, Spain
Mario Gestoso, MD principal investigator
Kovacs Foundation,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 Education (Back Comic-Book) 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 7 Dec 2009. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of the effectiveness of a prevention campaign promoting active management of low back pain in shifting beliefs in 6 to 8 year old schoolchildren. (time frame: 4 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?
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 7 Dec 2009.