Low Back Pain After Epidural Steroid InjectionNCT02162940
Statin and Epidural Steroid Injection
An observational study of Low Back Pain After Epidural Steroid Injection and Quality of Life After Epidural Steroid Injection, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
The impact of statin use on response to epidural steroid injections remains unknown and may well increase the effect considering the substantial anti-inflammatory properties. We thus tested the primary hypothesis that patients taking statins before and after the procedure will have lower VAS scores compared to… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain After Epidural Steroid Injection, Quality of Life After Epidural Steroid Injection
- What is being tested?
- Visual analogue score and The SF 36 test
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2012to Dec 2013
- How long will I take part?
- 6 Months
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients coming to the Algology Department with complaints of low back pain and scheduled to receive Transforaminal epidural steroid injection. Statin users (Group 1) and non-statin users (Group 2) will be record.
Who may be able to join
- indication for TAESI given by blinded pain physician
Who cannot join
- known allergy to steroids
- indication for surgery
- unstable opioid use
- drug or alcohol abuse within 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department
Aydin, 09100
About this study
Official title: Effect of Statin Use on Low Back Pain Steroid Injections.
The impact of statin use on response to epidural steroid injections remains unknown and may well increase the effect considering the substantial anti-inflammatory properties. We thus tested the primary hypothesis that patients taking statins before and after the procedure will have lower VAS scores compared to patients not on statins. Secondarily we tested the hypothesis that statin users will have improved quality of life evaluated with Short Form 36 (SF 36).
Read the detailed description
Low back pain is one of the most common complaints for physician office visits and is the most common disorder requiring interventional pain treatment in USA. Fluoroscopy-assisted transforaminal anterior epidural steroid injections (TAESI) are more commonly preferred for treatment of low back pain. Most of the time epidural steroid injections are supplemented with different analgesic combinations due to insufficient analgesia. Recent reports have revealed immunomodulatory and anti-inflammatory activities for statins in vivo and in vitro. Statins have very recently been shown to alleviate neuropathic pain in the rat model. However, the impact of statin use on response to epidural steroid injections remains unknown and may well increase the effect considering the substantial anti-inflammatory properties. We thus tested the primary hypothesis that patients taking statins before and after the procedure will have lower VAS scores compared to patients not on statins. Secondarily we tested the hypothesis that statin users will have improved quality of life evaluated with Short Form 36 (SF 36).
- Conditions
- Low Back Pain After Epidural Steroid Injection, Quality of Life After Epidural Steroid Injection
- Being tested
- Visual analogue score, The SF 36 test
- Keywords
- low back pain, epidural steroid injection, statin, quality of life
- 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.
Visual analogue scoreOther
Also called VAS score
Visual analogue score vas used to evaluate pain.
The SF 36 testOther
Also called SHORT FORM 36
The SF 36 test (SHORT FORM 36) was used to evaluate quality of life.
| Study group | Role | What they receive |
|---|---|---|
| patients taking statins | Visual anlogue score vas used to evaluate pain. The SF 36 test was used to evaluate quality of life. Receives: Other: Visual analogue score; Other: The SF 36 test | |
| patients not taking statins | Visual anlogue score vas used to evaluate pain.The SF 36 test was used to evaluate quality of life. Receives: Other: Visual analogue score; Other: The SF 36 test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low back pain after transforaminal epidural steroid injection assessed by VAS scale.
Measured: 6 months
Secondary outcomes (1)
Quality of life was evaluated with SF 12 test.
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 posted13 Jun 2014 (estimated)
- Study startApr 2012
- Primary completionDec 2013
- Study completionDec 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 Low Back Pain After Epidural Steroid InjectionStudies 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
- Prospective
- Enrolment
- 300 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SINEM SARI, Aydin Adnan Menderes University
- Investigators
- Osman Nuri Aydın, Prof, Principal investigator, Adnan Menderes University Medical Faculty Algology DepartmentBanu Taşdemir, Asist Dr, Principal investigator, Adnan Menderes University Medical Faculty Anesthesiology and Reanimation DepartmentFabrizio Galimberti, Medical Student, Principal investigator, Cleveland ClinicLernerCollege of Medicine, Cleveland, OhioAlparslan Turan, Associate Prof, Principal investigator, The Cleveland ClinicSinem Sari, Assist Prof, Study chair, Adnan Menderes University Medical Faculty Anesthesiology and Reanimation Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162940
- Sponsor's protocol ID
- SARI-06
- Status last verified
- Jun 2014
- First submitted
- 10 Jun 2014
- Last updated
- 13 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gillon JT, Smith SE, Lowden MR. Atorvastatin as novel treatment for neuropathic pain: a case report. Clin J Pain. 2013 Dec;29(12):e46-8. doi: 10.1097/AJP.0b013e3182a03c2e.
PubMed 23887344
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Statin Use on Low Back Pain Steroid Injections.
- ClinicalTrials.gov ID
- NCT02162940
- Acronym / sponsor ID
- SARI-06
- Conditions
- Low Back Pain After Epidural Steroid Injection, Quality of Life After Epidural Steroid Injection
- Keywords
- low back pain, epidural steroid injection, statin, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 13 Jun 2014 (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 impact of statin use on response to epidural steroid injections remains unknown and may well increase the effect considering the substantial anti-inflammatory properties. We thus tested the primary hypothesis that patients taking statins before and after the procedure will have lower VAS scores compared to patients not on statins. Secondarily we tested the hypothesis that statin users will have improved quality of life evaluated with Short Form 36 (SF 36).
Detailed description
Low back pain is one of the most common complaints for physician office visits and is the most common disorder requiring interventional pain treatment in USA. Fluoroscopy-assisted transforaminal anterior epidural steroid injections (TAESI) are more commonly preferred for treatment of low back pain. Most of the time epidural steroid injections are supplemented with different analgesic combinations due to insufficient analgesia. Recent reports have revealed immunomodulatory and anti-inflammatory activities for statins in vivo and in vitro. Statins have very recently been shown to alleviate neuropathic pain in the rat model. However, the impact of statin use on response to epidural steroid injections remains unknown and may well increase the effect considering the substantial anti-inflammatory properties. We thus tested the primary hypothesis that patients taking statins before and after the procedure will have lower VAS scores compared to patients not on statins. Secondarily we tested the hypothesis that statin users will have improved quality of life evaluated with Short Form 36 (SF 36).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients taking statins | – | Other: Visual analogue score, Other: The SF 36 testVisual anlogue score vas used to evaluate pain. The SF 36 test was used to evaluate quality of life. |
| patients not taking statins | – | Other: Visual analogue score, Other: The SF 36 testVisual anlogue score vas used to evaluate pain.The SF 36 test was used to evaluate quality of life. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients coming to the Algology Department with complaints of low back pain and scheduled to receive Transforaminal epidural steroid injection. Statin users (Group 1) and non-statin users (Group 2) will be record.
Key inclusion criteria (1 listed)
- indication for TAESI given by blinded pain physician
Key exclusion criteria (4 listed)
- known allergy to steroids
- indication for surgery
- unstable opioid use
- drug or alcohol abuse within 6 months
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 |
|---|---|---|
| Visual analogue scoreAlso: VAS scoreVisual analogue score vas used to evaluate pain. | Other | patients not taking statins, patients taking statins |
| The SF 36 testAlso: SHORT FORM 36The SF 36 test (SHORT FORM 36) was used to evaluate quality of life. | Other | patients not taking statins, patients taking statins |
Primary outcome
Low back pain after transforaminal epidural steroid injection assessed by VAS scale.
Time frame: 6 months
1 secondary outcome
Quality of life was evaluated with SF 12 test.
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 13 Jun 2014.
- Results publication: PubMed 23887344Gillon JT, Smith SE, Lowden MR. Atorvastatin as novel treatment for neuropathic pain: a case report. Clin J Pain. 2013 Dec;29(12):e46-8. doi: 10.1097/AJP.0b013e3182a03c2e.
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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.
Osman Nuri Aydın, Prof principal investigator
Adnan Menderes University Medical Faculty Algology Department
Banu Taşdemir, Asist Dr principal investigator
Adnan Menderes University Medical Faculty Anesthesiology and Reanimation Department
Fabrizio Galimberti, Medical Student principal investigator
Cleveland ClinicLernerCollege of Medicine, Cleveland, Ohio
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 After Epidural Steroid Injection and Quality of Life After Epidural Steroid Injection, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
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 4 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 13 Jun 2014. 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 Turkey (Türkiye). 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?
Low back pain after transforaminal epidural steroid injection assessed by VAS scale. (time frame: 6 months). 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 NCT02162940, 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 13 Jun 2014.