Low Back PainNCT00665821
The Effect of Two Short Education Programs for Nonspecific Low Back Pain in a Workers' Health Care Organization
A study testing Classic back pain prevention education, and cognitive behavioral management. and General health education in people with Low Back Pain, run by Kovacs Foundation at 2 sites in Spain.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Classic back pain prevention education, and cognitive behavioral management. and General health education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 657 participants
- Where
- 2 sitesSpain
- Study dates
- Sep 2008to Feb 2011
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- low back pain patients, with or without referred or radiated pain
- no systemic disease or criteria for referral to surgery
Who cannot join
- inability to fill out the questionnaires and scales
- bedridden
- rheumatologic inflammatory disease, cancer or fibromyalgia
- suspicion of fibromyalgia
- spinal fracture
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Kovacs Foundation
Palma de Mallorca, Balearic Islands, 07012
Hospital Laboral SOLIMAT
Toledo, Castille-La Mancha, 45004
About this study
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
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
- Being tested
- Classic back pain prevention education, and cognitive behavioral management., General health education
- Keywords
- nonspecific low back pain, disability, sick leave, catastrophizing, workers
- 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.
Classic back pain prevention education, and cognitive behavioral management.Behavioural
Classic education: postural hygiene, Back Guide. Cognitive behavioral management: active management, Back Book.
General health educationBehavioural
General health education: a booklet describing general norms for maintaining good health
What is being measured
The primary outcome is the main question the study is designed to answer.
A reduction in low back pain related disability and sick leave.
Measured: 365 days
Secondary outcomes (1)
A reduction in catastrophizing beliefs related to low back pain.
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startSep 2008
- Primary completionNov 2010
- Study completionFeb 2011
Why it stopped: From Sept./08 to April/09 only 30 subjects were recruited. It has proved extremely difficult to recruit subjects.
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, Outcomes assessor
- Enrolment
- 657 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kovacs Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Laboral SOLIMAT
- Responsible party
- Sponsor
- Investigators
- Francisco M Kovacs, MD, PhD, Study director, Kovacs Foundation, Palma de Mallorca, 07012, SpainAndrés Barriga, MD, Principal investigator, Hospital Laboral Solimat, Toledo, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00665821
- Sponsor's protocol ID
- FK-S-24
- Status last verified
- Aug 2019
- First submitted
- 23 Apr 2008
- Last updated
- 28 Aug 2019
- 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 10626311Frost 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.
PubMed 15377573Kovacs 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.
PubMed 17471084
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00665821
- Acronym / sponsor ID
- FK-S-24
- Conditions
- Low Back Pain
- Keywords
- nonspecific low back pain, disability, sick leave, catastrophizing, workers
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: From Sept./08 to April/09 only 30 subjects were recruited. It has proved extremely difficult to recruit subjects.
- Enrolment
- 657 participants (actual)
- Lead sponsor
- Kovacs FoundationUniversity, hospital or other
- Collaborators
- Hospital Laboral SOLIMAT
- Study start
- Sep 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 24 Apr 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 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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- low back pain patients, with or without referred or radiated pain
- no systemic disease or criteria for referral to surgery
Key exclusion criteria (5 listed)
- inability to fill out the questionnaires and scales
- bedridden
- rheumatologic inflammatory disease, cancer or fibromyalgia
- suspicion of fibromyalgia
- spinal fracture
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 |
|---|---|---|
| Classic back pain prevention education, and cognitive behavioral management.Classic education: postural hygiene, Back Guide. Cognitive behavioral management: active management, Back Book. | Behavioural | – |
| General health educationGeneral health education: a booklet describing general norms for maintaining good health | Behavioural | – |
Primary outcome
A reduction in low back pain related disability and sick leave.
Time frame: 365 days
1 secondary outcome
A reduction in catastrophizing beliefs related to low back pain.
Time frame: 365 days
Results and safety
The study was stopped early (reason given: From Sept./08 to April/09 only 30 subjects were recruited. It has proved extremely difficult to recruit subjects.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- 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 15377573Frost 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.
- Background: PubMed 17471084Kovacs 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.
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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, 07012, Spain
Andrés Barriga, MD principal investigator
Hospital Laboral Solimat, Toledo, Spain
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Classic back pain prevention education, and cognitive behavioral management. and General health education in people with Low Back Pain, run by Kovacs Foundation at 2 sites 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 5 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: stopped early, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 stopped early (reason given: From Sept./08 to April/09 only 30 subjects were recruited. It has proved extremely difficult to recruit subjects.). Results are not available in the source record.
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?
A reduction in low back pain related disability and sick leave. (time frame: 365 days). 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 NCT00665821, 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 28 Aug 2019.