Chronic Low Back PainNCT00960583
Economic Evaluation of an Exercise Program After Multidisciplinary Rehabilitation in Patients With Chronic Low Back Pain
A study testing Exercise program and Routine follow-up in people with Chronic Low Back Pain, run by University of Lausanne at 1 site in Switzerland.
Trial summary
The purpose of the study is to compare, after functional multidisciplinary rehabilitation for chronic low back pain, an exercise program to the routine follow-up which is simply to advice patients to exercise regularly at home. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Exercise program and Routine follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2005to Oct 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- subacute or chronic low back pain
- phases 2 to 6 of the Krause classification
- without irritative neurological deficit
- age between 18 and 60
- having completed functional multidisciplinary rehabilitation
Who cannot join
- phases 7 and 8 of the Krause classification
- entitled to a total disability pension
- acute neurological deficit in progress
- sciatica
- pregnancy
- acute inflammatory rheumatic disease
Show all 14Show fewer
- non-osteoarticular thoracic pain
- spinal fracture within the last 3 months
- osteoporosis
- tumor
- severe heart failure or respiratory failure
- active drug addiction
- current involvement in litigation related to low back pain
- active psychiatric pathology
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Université de Lausanne, Service de Rhumatologie, Département de l'Appareil Locomoteur
Lausanne
About this study
Official title: Cost-utility Analysis of a 3-month Exercise Program vs. Routine Follow-up in Patients Having Completed Multidisciplinary Rehabilitation: a Randomized Controlled Trial
The purpose of the study is to compare, after functional multidisciplinary rehabilitation for chronic low back pain, an exercise program to the routine follow-up which is simply to advice patients to exercise regularly at home. The exercise program should help patients stay active, which should translate into a better long term quality of life and decreased days off work.
- Conditions
- Chronic Low Back Pain
- Being tested
- Exercise program, Routine follow-up
- Keywords
- Chronic low back pain, Multidisciplinary rehabilitation, Exercise, Cost-effectiveness
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise programOther
24 group exercise sessions during 12 weeks
Routine follow-upOther
Advice to stay active
| Study group | Role | What they receive |
|---|---|---|
| Exercise program | Experimental | Exercise program comprising muscle strengthening, cardiovascular training and stretching exercises.
Program duration : 12 weeks Sessions frequency : twice per week Session duration : 1h30 Receives: Other: Exercise program |
| Routine follow-up | Active comparator | Routine follow-up after functional multidisciplinary rehabilitation by attending physician (Advice to stay active) Receives: Other: Routine follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Measured: End of functional multidisciplinary rehabilitation, 1 year follow-up
Direct and indirect costs
Measured: Before functional multidisciplinary rehabilitation, 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2009 (estimated)
- Study startJan 2005
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yves Henchoz, University of Lausanne
- Investigators
- Alexander KL So, PhD, FRCP, Study director, Université de Lausanne, Service de Rhumatologie, Département de l'Appareil Locomoteur, Lausanne, SuissePierre de Goumoëns, MD, Study chair, Université de Lausanne, Service de Rhumatologie, Département de l'Appareil Locomoteur, Lausanne, SuisseMichael Norberg, MD, Study chair, Université de Lausanne, Service de Rhumatologie, Département de l'Appareil Locomoteur, Lausanne, SuisseRoland Paillex, PT, MS, Study chair, Centre Hospitalier Universitaire Vaudois (CHUV), Direction des soins, Lausanne, SuisseChristophe Pinget, PhD, Study chair, Institute of Health Economics and Management, University of Lausanne and Health Technology Assessment Unit, Medical Direction, University Hospital of Lausanne (CHUV)Jean-Blaise Wasserfallen, MD, MPP, Study chair, Institute of Health Economics and Management, University of Lausanne and Health Technology Assessment Unit, Medical Direction, University Hospital of Lausanne (CHUV)Yves Henchoz, MS, Principal investigator, Université de Lausanne, Institut des sciences du sport et de l'éducation physique, Lausanne, Suisse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00960583
- Sponsor's protocol ID
- UNIL_PAPA
- Status last verified
- May 2016
- First submitted
- 17 Aug 2009
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Henchoz Y, de Goumoens P, Norberg M, Paillex R, So AK. Role of physical exercise in low back pain rehabilitation: a randomized controlled trial of a three-month exercise program in patients who have completed multidisciplinary rehabilitation. Spine (Phila Pa 1976). 2010 May 20;35(12):1192-9. doi: 10.1097/BRS.0b013e3181bf1de9.
PubMed 20098350Henchoz Y, Pinget C, Wasserfallen JB, Paillex R, de Goumoens P, Norberg M, Kai-Lik So A. Cost-utility analysis of a three-month exercise programme vs usual care following multidisciplinary rehabilitation for chronic low back pain. J Rehabil Med. 2010 Oct;42(9):846-52. doi: 10.2340/16501977-0610.
PubMed 20878045
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-utility Analysis of a 3-month Exercise Program vs. Routine Follow-up in Patients Having Completed Multidisciplinary Rehabilitation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00960583
- Acronym / sponsor ID
- UNIL_PAPA
- Conditions
- Chronic Low Back Pain
- Keywords
- Chronic low back pain, Multidisciplinary rehabilitation, Exercise, Cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 18 Aug 2009 (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 the study is to compare, after functional multidisciplinary rehabilitation for chronic low back pain, an exercise program to the routine follow-up which is simply to advice patients to exercise regularly at home. The exercise program should help patients stay active, which should translate into a better long term quality of life and decreased days off work.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise program | Experimental | Other: Exercise programExercise program comprising muscle strengthening, cardiovascular training and stretching exercises. Program duration : 12 weeks Sessions frequency : twice per week Session duration : 1h30 |
| Routine follow-up | Active comparator | Other: Routine follow-upRoutine follow-up after functional multidisciplinary rehabilitation by attending physician (Advice to stay active) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- subacute or chronic low back pain
- phases 2 to 6 of the Krause classification
- without irritative neurological deficit
- age between 18 and 60
- having completed functional multidisciplinary rehabilitation
Key exclusion criteria (14 listed)
- phases 7 and 8 of the Krause classification
- entitled to a total disability pension
- acute neurological deficit in progress
- sciatica
- pregnancy
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 |
|---|---|---|
| Exercise program24 group exercise sessions during 12 weeks | Other | Exercise program |
| Routine follow-upAdvice to stay active | Other | Routine follow-up |
Primary outcome
Quality of life
Time frame: End of functional multidisciplinary rehabilitation, 1 year follow-up
Direct and indirect costs
Time frame: Before functional multidisciplinary rehabilitation, 1 year follow-up
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 11 May 2016.
- Results publication: PubMed 20098350Henchoz Y, de Goumoens P, Norberg M, Paillex R, So AK. Role of physical exercise in low back pain rehabilitation: a randomized controlled trial of a three-month exercise program in patients who have completed multidisciplinary rehabilitation. Spine (Phila Pa 1976). 2010 May 20;35(12):1192-9. doi: 10.1097/BRS.0b013e3181bf1de9.
- Results publication: PubMed 20878045Henchoz Y, Pinget C, Wasserfallen JB, Paillex R, de Goumoens P, Norberg M, Kai-Lik So A. Cost-utility analysis of a three-month exercise programme vs usual care following multidisciplinary rehabilitation for chronic low back pain. J Rehabil Med. 2010 Oct;42(9):846-52. doi: 10.2340/16501977-0610.
Related trials for Chronic Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
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.
Alexander KL So, PhD, FRCP study director
Université de Lausanne, Service de Rhumatologie, Département de l'Appareil Locomoteur, Lausanne, Suisse
Pierre de Goumoëns, MD study chair
Université de Lausanne, Service de Rhumatologie, Département de l'Appareil Locomoteur, Lausanne, Suisse
Michael Norberg, MD study chair
Université de Lausanne, Service de Rhumatologie, Département de l'Appareil Locomoteur, Lausanne, Suisse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise program and Routine follow-up in people with Chronic Low Back Pain, run by University of Lausanne at 1 site in Switzerland.
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 5 inclusion and 14 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 11 May 2016. 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 Switzerland. 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?
Quality of life (time frame: End of functional multidisciplinary rehabilitation, 1 year follow-up). 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 NCT00960583, which also lists 2 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 11 May 2016.