Low Back PainPhase 2NCT00361556
Treatment for Nonspecific Low Back Pain in Primary Care: a Trial on Different Health Education Booklets
A Phase 2 study testing The Back Book, The Back Guide and General health book 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 the effectiveness on the disability of low back pain patients of The Back Book, The Back Guide, and a control intervention (generic recommendations on general health). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- The Back Book, The Back Guide and General health book
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2005to Dec 2012
- Phase
- Phase 2
- 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 years and older
- 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;
- without red flags for systemic disease or criteria for surgery.
Who cannot join
- Inability to read the handout or to fill out the questionnaires;
- habitually in a prostrate position;
- diagnosis of inflammatory rheumatologic disease, cancer or fibromyalgia; suspicion of fibromyalgia.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Primary care Centers affiliated with the Spanish Back Pain Research Network
Throughout Spain
About this study
Official title: Treatment for Nonspecific Low Back Pain in Primary Care With Standardized Health Education Booklets: A Randomized Controlled Clinical Trial
The primary purpose of this study is to compare the effectiveness on the disability of low back pain patients of The Back Book, The Back Guide, and a control intervention (generic recommendations on general health). Patients are divided into 3 groups:those who receive The Back Book (classic education), those who receive The Back Guide (cognitive behavioral education) and the control group). They are patients who consult a physician at the primary care consults of 14 different Health Centers in Spain. The sample size is 240 subjects.
- Conditions
- Low Back Pain
- Being tested
- The Back Book, The Back Guide, General health book
- Keywords
- low back pain, disability, health education, primary care
- 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 BookBehavioural
A book on how to prevent back pain
The Back GuideBehavioural
A guide for the prevention of back pain.
General health bookBehavioural
A book on general health
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | The Back Book Receives: Behavioral: The Back Book; Behavioral: The Back Guide; Behavioral: General health book |
| 2 | Active comparator | The Back Guide Receives: Behavioral: The Back Guide; Behavioral: General health book |
| 3 | Active comparator | General health book Receives: Behavioral: General health book |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of disability at 180 days of follow-up.
Measured: 6 months
Secondary outcomes (1)
Catastrophizing and days on sick leave at 180 days of follow-up.
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 posted8 Aug 2006 (estimated)
- Study startOct 2005
- Primary completionSep 2012
- Study completionDec 2012
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 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kovacs Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Back Pain Research Network (REIDE)
- Responsible party
- Principal investigator, Francisco M. Kovacs, Kovacs Foundation
- Investigators
- Francisco M. Kovacs, MD, PhD, Study chair, Kovacs Foundation, Palma de Mallorca, 07012, SpainCarmen Fernández, MD, Principal investigator, Centro de Salut de Valldargent, Palma de Mallorca 07013, SpainAntonio Ruiz, MD, Study director, Centro de Salud Las Ciudades, Madrid 28903, SpainCarlos Isanta, MD, Study director, Centro de Salud de San José, Zaragoza 50013, SpainVioleta González, MD, Study director, Centro de Salud Gazteleku, Bilbao 48007, SpainPablo Panero, MD, Study director, Centro de Salud de Órgiva, Órgiva, Granada 18400, SpainMargarita Gómez, MD, Study director, Centro de Salud Casa del Mar, Palma de Mallorca 07012, SpainFrancisco Martínez, MD, Study director, Centro de Salud de Bembibre, Bembibre, León 24300, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00361556
- Sponsor's protocol ID
- FK-R-11
- Status last verified
- Mar 2014
- First submitted
- 4 Aug 2006
- Last updated
- 13 Mar 2014
- 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 11322842Hagen EM, Eriksen HR, Ursin H. Does early intervention with a light mobilization program reduce long-term sick leave for low back pain? Spine (Phila Pa 1976). 2000 Aug 1;25(15):1973-6. doi: 10.1097/00007632-200008010-00017.
PubMed 10908942
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment for Nonspecific Low Back Pain in Primary Care With Standardized Health Education Booklets: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT00361556
- Acronym / sponsor ID
- FK-R-11
- Conditions
- Low Back Pain
- Keywords
- low back pain, disability, health education, primary care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Kovacs FoundationUniversity, hospital or other
- Collaborators
- Spanish Back Pain Research Network (REIDE)
- Study start
- Oct 2005
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 8 Aug 2006 (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 the effectiveness on the disability of low back pain patients of The Back Book, The Back Guide, and a control intervention (generic recommendations on general health). Patients are divided into 3 groups:those who receive The Back Book (classic education), those who receive The Back Guide (cognitive behavioral education) and the control group). They are patients who consult a physician at the primary care consults of 14 different Health Centers in Spain. The sample size is 240 subjects.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: The Back Book, Behavioral: The Back Guide, Behavioral: General health bookThe Back Book |
| 2 | Active comparator | Behavioral: The Back Guide, Behavioral: General health bookThe Back Guide |
| 3 | Active comparator | Behavioral: General health bookGeneral health book |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Low back pain patients,
- with or without referred or radiated pain;
- without red flags for systemic disease or criteria for surgery.
Key exclusion criteria (3 listed)
- Inability to read the handout or to fill out the questionnaires;
- habitually in a prostrate position;
- diagnosis of inflammatory rheumatologic disease, cancer or fibromyalgia; suspicion of fibromyalgia.
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 BookA book on how to prevent back pain | Behavioural | 1 |
| The Back GuideA guide for the prevention of back pain. | Behavioural | 1, 2 |
| General health bookA book on general health | Behavioural | 1, 2, 3 |
Primary outcome
Degree of disability at 180 days of follow-up.
Time frame: 6 months
1 secondary outcome
Catastrophizing and days on sick leave at 180 days of follow-up.
Time frame: 6 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 13 Mar 2014.
- 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 10908942Hagen EM, Eriksen HR, Ursin H. Does early intervention with a light mobilization program reduce long-term sick leave for low back pain? Spine (Phila Pa 1976). 2000 Aug 1;25(15):1973-6. doi: 10.1097/00007632-200008010-00017.
- Spanish Back Pain Research Network site that describes objectives and projects of its members.Link provided by the sponsor.
Related trials for Low Back Pain
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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 chair
Kovacs Foundation, Palma de Mallorca, 07012, Spain
Carmen Fernández, MD principal investigator
Centro de Salut de Valldargent, Palma de Mallorca 07013, Spain
Antonio Ruiz, MD study director
Centro de Salud Las Ciudades, Madrid 28903, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing The Back Book, The Back Guide and General health 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 3 inclusion and 3 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 13 Mar 2014. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Degree of disability at 180 days of follow-up. (time frame: 6 months). 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 NCT00361556, 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 13 Mar 2014.