Low Back PainNCT01330875
Lumbar Infiltration With Steroids - Effects on Pain Reduction
An observational study of Low Back Pain, run by University of Zurich at 1 site in Switzerland.
Trial summary
Questionnaire for patients who got a lumbar infiltration in our clinic. The patients will have to answer questions concerning their pain. (The lumbar infiltration itself is not part of this study) 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?
- survey
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2010to Dec 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: Patients who got a lumbar infiltration in our clinic. The patients will have to answer questions concerning their pain (the lumbar infiltration itself is not part of this study).
Who may be able to join
- Patients who got a lumbar infiltration in our clinic.
Who cannot join
- Infiltration of thoracal or cervical spine.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Rheumatology
Zurich
About this study
Questionnaire for patients who got a lumbar infiltration in our clinic. The patients will have to answer questions concerning their pain. (The lumbar infiltration itself is not part of this study)
Read the detailed description
Questionnaire are given to patients who got a lumbar infiltration in our clinic of rheumatology. These patients will have to answer questions concerning their pain. (The lumbar infiltration itself is not part of this study).
- Conditions
- Low Back Pain
- Being tested
- survey
- 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.
surveyOther
no intervention. Only questionnaire after lumbar infiltration with steroids - effects on pain reduction
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction
on visual analog scale
Measured: week 1 and 3; month 3, 6, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2013
- Study completionDec 2013
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.
- More trials run by University of ZurichThe 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandra Blumhardt, MD, Principal investigator, University Hospital Zurich, Division of Rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330875
- Sponsor's protocol ID
- LINFRUZ01
- Status last verified
- May 2015
- First submitted
- 5 Apr 2011
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumbar Infiltration With Steroids - Effects on Pain Reduction
- ClinicalTrials.gov ID
- NCT01330875
- Acronym / sponsor ID
- LINFRUZ01
- Conditions
- Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 7 Apr 2011 (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.
Questionnaire for patients who got a lumbar infiltration in our clinic. The patients will have to answer questions concerning their pain. (The lumbar infiltration itself is not part of this study)
Detailed description
Questionnaire are given to patients who got a lumbar infiltration in our clinic of rheumatology. These patients will have to answer questions concerning their pain. (The lumbar infiltration itself is not part of this study).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who got a lumbar infiltration in our clinic. The patients will have to answer questions concerning their pain (the lumbar infiltration itself is not part of this study).
Key inclusion criteria (1 listed)
- Patients who got a lumbar infiltration in our clinic.
Key exclusion criteria (1 listed)
- Infiltration of thoracal or cervical spine.
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 |
|---|---|---|
| surveyno intervention. Only questionnaire after lumbar infiltration with steroids - effects on pain reduction | Other | – |
Primary outcome
Pain reduction
Time frame: week 1 and 3; month 3, 6, 12
on visual analog scale
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 3 Jun 2015.
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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.
Sandra Blumhardt, MD principal investigator
University Hospital Zurich, Division of Rheumatology
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 University of Zurich 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: finished, as of the sponsor's last update on 3 Jun 2015. 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?
Pain reduction (time frame: week 1 and 3; month 3, 6, 12). 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 Jun 2015.