Low Back PainPhase 2NCT00439764
Health Education vs. Health Education Plus Physical Therapy for Low Back Pain Patients
A Phase 2 study testing General health talk, Handout of The Back Book and Back exercise 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 assess the effectiveness of a brief educational program and of an additional program in physical therapy, for the treatment of low back pain in Primary Care of the Spanish National Health Service. This is a controlled, cluster randomized community trial. 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?
- General health talk, Handout of The Back Book and Back exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 680 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2007to Sep 2008
- 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
- Consultation for low back pain, with or without referred or radiated pain; no signs of systemic disease or criteria for surgery.
Who cannot join
- Inability to fill out the questionnaires (blindness, dementia, illiteracy; total habitual prostration;
- Diagnosis of rheumatologic inflammatory disease, fibromyalgia or cancer in last 5 years;
- Suspicion of fibromyalgia.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Servicio de Atención Primaria del SACYL
Valladolid, Castille and León, 47005
About this study
The primary purpose of this study is to assess the effectiveness of a brief educational program and of an additional program in physical therapy, for the treatment of low back pain in Primary Care of the Spanish National Health Service. This is a controlled, cluster randomized community trial.
- Conditions
- Low Back Pain
- Being tested
- General health talk, Handout of The Back Book, Back exercise
- Keywords
- Low back pain, health education, physical therapy
- 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.
General health talkBehavioural
Routine clinical practice and talk on general health
Handout of The Back BookBehavioural
Talk on health of the back and handout of The Back Book
Back exerciseBehavioural
Routine clinical practice, talk on back health, handout of The Back Book and back exercise
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Routine clinical practice and talk on general health Receives: Behavioral: General health talk; Behavioral: Handout of The Back Book; Behavioral: Back exercise |
| 2 | Active comparator | Talk on back health and handout of The Back Book Receives: Behavioral: Handout of The Back Book; Behavioral: Back exercise |
| 3 | Active comparator | Routine clinical practice, talk on back health, handout of The Back Book and back exercise Receives: Behavioral: Back exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of pain, measured at baseline, 90, and 180 days later
Measured: 6 months
Disability, measured at baseline, 90, and 180 days later
Measured: 6 months
Sick leave, measured at baseline, 90, and 180 days later
Measured: 6 months
Secondary outcomes (2)
Fear avoidance beliefs, measured at baseline, 90, and 180 days later
Measured: 6 months
Quality of life, measured at baseline, 90, and 180 days later
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 posted26 Feb 2007 (estimated)
- Study startMar 2007
- Primary completionAug 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 680 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kovacs Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Consejería de Sanidad, Junta de Castilla y León
- Investigators
- Francisco M Kovacs, MD, PhD, Study chair, Kovacs Foundation, Palma de Mallorca, 07012, SpainCelia Albaladejo, MD, Study director, Consejería de Sanidad, 47071 Valladolid, SpainRafael del Pino, PT, Principal investigator, Centro de Especialidades de Fisioterapia, 47014 Valladolid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00439764
- Sponsor's protocol ID
- FK-JCL-14
- Status last verified
- Nov 2008
- First submitted
- 23 Feb 2007
- Last updated
- 28 May 2009
- 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 11322842Frost 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 15377573Albaladejo C, Kovacs FM, Royuela A, del Pino R, Zamora J; Spanish Back Pain Research Network. The efficacy of a short education program and a short physiotherapy program for treating low back pain in primary care: a cluster randomized trial. Spine (Phila Pa 1976). 2010 Mar 1;35(5):483-96. doi: 10.1097/BRS.0b013e3181b9c9a7.
PubMed 20147875
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Education vs. Health Education Plus Physical Therapy for Low Back Pain Patients
- ClinicalTrials.gov ID
- NCT00439764
- Acronym / sponsor ID
- FK-JCL-14
- Conditions
- Low Back Pain
- Keywords
- Low back pain, health education, physical therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 680 participants (estimated)
- Lead sponsor
- Kovacs FoundationUniversity, hospital or other
- Collaborators
- Consejería de Sanidad, Junta de Castilla y León
- Study start
- Mar 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 26 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 assess the effectiveness of a brief educational program and of an additional program in physical therapy, for the treatment of low back pain in Primary Care of the Spanish National Health Service. This is a controlled, cluster randomized community trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: General health talk, Behavioral: Handout of The Back Book, Behavioral: Back exerciseRoutine clinical practice and talk on general health |
| 2 | Active comparator | Behavioral: Handout of The Back Book, Behavioral: Back exerciseTalk on back health and handout of The Back Book |
| 3 | Active comparator | Behavioral: Back exerciseRoutine clinical practice, talk on back health, handout of The Back Book and back exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consultation for low back pain, with or without referred or radiated pain; no signs of systemic disease or criteria for surgery.
Key exclusion criteria (3 listed)
- Inability to fill out the questionnaires (blindness, dementia, illiteracy; total habitual prostration;
- Diagnosis of rheumatologic inflammatory disease, fibromyalgia or cancer in last 5 years;
- 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 |
|---|---|---|
| General health talkRoutine clinical practice and talk on general health | Behavioural | 1 |
| Handout of The Back BookTalk on health of the back and handout of The Back Book | Behavioural | 1, 2 |
| Back exerciseRoutine clinical practice, talk on back health, handout of The Back Book and back exercise | Behavioural | 1, 2, 3 |
Primary outcome
Intensity of pain, measured at baseline, 90, and 180 days later
Time frame: 6 months
Disability, measured at baseline, 90, and 180 days later
Time frame: 6 months
Sick leave, measured at baseline, 90, and 180 days later
Time frame: 6 months
2 secondary outcomes
Fear avoidance beliefs, measured at baseline, 90, and 180 days later
Time frame: 6 months
Quality of life, measured at baseline, 90, and 180 days later
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 28 May 2009.
- 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 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.
- Derived from this study: PubMed 20147875Albaladejo C, Kovacs FM, Royuela A, del Pino R, Zamora J; Spanish Back Pain Research Network. The efficacy of a short education program and a short physiotherapy program for treating low back pain in primary care: a cluster randomized trial. Spine (Phila Pa 1976). 2010 Mar 1;35(5):483-96. doi: 10.1097/BRS.0b013e3181b9c9a7.
- Spanish Back Pain Research Network site that describes objectives and projects of its members.Link 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 chair
Kovacs Foundation, Palma de Mallorca, 07012, Spain
Celia Albaladejo, MD study director
Consejería de Sanidad, 47071 Valladolid, Spain
Rafael del Pino, PT principal investigator
Centro de Especialidades de Fisioterapia, 47014 Valladolid, 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 General health talk, Handout of The Back Book and Back exercise 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 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 28 May 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.
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?
Intensity of pain, measured at baseline, 90, and 180 days later (time frame: 6 months). The study lists 3 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 NCT00439764, which also lists 4 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 May 2009.