Comparison Between Effectiveness of Lumbar Fusion and Conservative TreatmentNCT01780194
Lumbar Fusion Compared With Conservative Treatment in Patients With Chronic Low Back Pain: a Meta-analysis
An observational study of Comparison Between Effectiveness of Lumbar Fusion and Conservative Treatment, run by Turku University Hospital.
Trial summary
To determine the effect size of lumbar fusion measured by Oswestry Disability Index and compared with conservative treatment in patients with chronic low back pain. Meta-analysis using fixed effect model synthesis method. Included studies were retrieved from Medline and Cochrane CENTRAL databases since 1990. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Comparison Between Effectiveness of Lumbar Fusion and Conservative Treatment
- How many people
- 666 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Feb 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with chronic low back pain due to degenerative spinal conditions
Who may be able to join
- controlled randomized or non-randomized studies
Who cannot join
- not specified
About this study
- To determine the effect size of lumbar fusion measured by Oswestry Disability Index and compared with conservative treatment in patients with chronic low back pain.
- Meta-analysis using fixed effect model synthesis method.
- Included studies were retrieved from Medline and Cochrane CENTRAL databases since 1990.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar fusion group | Not described | |
| Conservative treatment group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Comparison Between Effectiveness of Lumbar Fusion and Conservative TreatmentStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- 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
- Enrolment
- 666 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Mikhail Saltychev, PhD, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01780194
- Sponsor's protocol ID
- FUSION_META_TYH_2013
- Status last verified
- Nov 2013
- First submitted
- 29 Jan 2013
- Last updated
- 28 Nov 2013
- Results posted
- No
Publications
Saltychev M, Eskola M, Laimi K. Lumbar fusion compared with conservative treatment in patients with chronic low back pain: a meta-analysis. Int J Rehabil Res. 2014 Mar;37(1):2-8. doi: 10.1097/MRR.0b013e328363ba4b.
PubMed 23820296
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumbar Fusion Compared With Conservative Treatment in Patients With Chronic Low Back Pain: a Meta-analysis
- ClinicalTrials.gov ID
- NCT01780194
- Acronym / sponsor ID
- FUSION_META_TYH_2013
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 666 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- Dec 2012
- Primary completion
- Feb 2013 (actual)
- First posted
- 30 Jan 2013 (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.
- To determine the effect size of lumbar fusion measured by Oswestry Disability Index and compared with conservative treatment in patients with chronic low back pain.
- Meta-analysis using fixed effect model synthesis method.
- Included studies were retrieved from Medline and Cochrane CENTRAL databases since 1990.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumbar fusion group | – | – |
| Conservative treatment group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with chronic low back pain due to degenerative spinal conditions
Key inclusion criteria (1 listed)
- controlled randomized or non-randomized studies
Key exclusion criteria (1 listed)
- not specified
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oswestry Disability Index
Time frame: 2 years
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 Nov 2013.
- Derived from this study: PubMed 23820296Saltychev M, Eskola M, Laimi K. Lumbar fusion compared with conservative treatment in patients with chronic low back pain: a meta-analysis. Int J Rehabil Res. 2014 Mar;37(1):2-8. doi: 10.1097/MRR.0b013e328363ba4b.
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.
Mikhail Saltychev, PhD principal investigator
Turku University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Comparison Between Effectiveness of Lumbar Fusion and Conservative Treatment, run by Turku University Hospital.
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: finished, as of the sponsor's last update on 28 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Oswestry Disability Index (time frame: 2 years). 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 NCT01780194, which also lists 1 linked publication.
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 Nov 2013.