Low Back PainNCT00652236
Cost of Long Term Disability in Patients With Chronic Non-Specific Low Back Pain
An observational study of Low Back Pain, run by Klinik Valens at 1 site in Switzerland.
Trial summary
The purpose of the study was to determine the cost-effectiveness of a function-centred treatment (FCT) compared with a pain-centred treatment (PCT) in patients with chronic low back pain (LBP) in an in-patient setting. Follow-up lasted three years. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Physiotherapy
- How many people
- 174 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2006to Feb 2008
- Phase
- Observational
- 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Tertiary rehabilitaton centre
Who may be able to join
- Chronic low back pain, sick leave of 6 weeks during the last 6 months
Who cannot join
- not able to perform a training program
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Rehabilitationszentrum Klinik Valens
Valens, Canton of St. Gallen, CH- 7317
About this study
Official title: Cost of Long Term Disability in Patients With Chronic Non-Specific Low Back Pain. Three-Year Follow up of a Randomized Trial
The purpose of the study was to determine the cost-effectiveness of a function-centred treatment (FCT) compared with a pain-centred treatment (PCT) in patients with chronic low back pain (LBP) in an in-patient setting. Follow-up lasted three years. Direct and indirect costs were recorded by questionnaires sent to health insurances, employers and Swiss Disability Insurance Company.
- Conditions
- Low Back Pain
- Being tested
- Physiotherapy
- Keywords
- Low back pain, Economics, Cost-effectiveness
- 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.
PhysiotherapyOther
The two groups passed an in-patient rehabilitation and a physiotherapy: FCT function-centred vs. PCT pain-centred
| Study group | Role | What they receive |
|---|---|---|
| FCT | Patients passing a function- centred rehabilitation Receives: Other: Physiotherapy | |
| PCT | Patients passing a pain-centred rehabilitation Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
cost- effectiveness
Measured: 3 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 posted3 Apr 2008 (estimated)
- Study startJan 2006
- Primary completionDec 2007
- Study completionFeb 2008
Why it stopped: Study was terminated according the study protocol end of 2007
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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinik Valens
- Sponsor type
- University, hospital or other
- Collaborators
- University of Applied Sciences of Western Switzerland, Zurich University of Applied Sciences
- Investigators
- Stefan Bachmann, MD, Principal investigator, Rehabilitationszentrum Klinik Valens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00652236
- Sponsor's protocol ID
- 405340-111500
- Status last verified
- Mar 2008
- First submitted
- 27 Mar 2008
- Last updated
- 3 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost of Long Term Disability in Patients With Chronic Non-Specific Low Back Pain. Three-Year Follow up of a Randomized Trial
- ClinicalTrials.gov ID
- NCT00652236
- Acronym / sponsor ID
- 405340-111500
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Economics, Cost-effectiveness
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was terminated according the study protocol end of 2007
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Klinik ValensUniversity, hospital or other
- Collaborators
- University of Applied Sciences of Western Switzerland, Zurich University of Applied Sciences
- Study start
- Jan 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 3 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 the study was to determine the cost-effectiveness of a function-centred treatment (FCT) compared with a pain-centred treatment (PCT) in patients with chronic low back pain (LBP) in an in-patient setting. Follow-up lasted three years. Direct and indirect costs were recorded by questionnaires sent to health insurances, employers and Swiss Disability Insurance Company.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FCT | – | Other: PhysiotherapyPatients passing a function- centred rehabilitation |
| PCT | – | Other: PhysiotherapyPatients passing a pain-centred rehabilitation |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Tertiary rehabilitaton centre
Key inclusion criteria (1 listed)
- Chronic low back pain, sick leave of 6 weeks during the last 6 months
Key exclusion criteria (1 listed)
- not able to perform a training program
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 |
|---|---|---|
| PhysiotherapyThe two groups passed an in-patient rehabilitation and a physiotherapy: FCT function-centred vs. PCT pain-centred | Other | FCT, PCT |
Primary outcome
cost- effectiveness
Time frame: 3 year follow-up
Results and safety
The study was stopped early (reason given: Study was terminated according the study protocol end of 2007). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2008.
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
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
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
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.
Stefan Bachmann, MD principal investigator
Rehabilitationszentrum Klinik Valens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Klinik Valens 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 1 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: stopped early, as of the sponsor's last update on 3 Apr 2008. 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 was stopped early (reason given: Study was terminated according the study protocol end of 2007). 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?
cost- effectiveness (time frame: 3 year follow-up). 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 3 Apr 2008.