Statin and Epidural Steroid Injection

June 12, 2014 updated by: SINEM SARI, Aydin Adnan Menderes University

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Aydın, Turkey, 09100
        • Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • indication for TAESI given by blinded pain physician

Exclusion Criteria:

  • known allergy to steroids
  • indication for surgery
  • unstable opioid use
  • drug or alcohol abuse within 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients taking statins
Visual anlogue score vas used to evaluate pain. The SF 36 test was used to evaluate quality of life.
Other: Visual analogue score
Visual analogue score vas used to evaluate pain.
Other Names:
  • VAS score
Other: The SF 36 test
The SF 36 test (SHORT FORM 36) was used to evaluate quality of life.
Other Names:
  • SHORT FORM 36
patients not taking statins
Visual anlogue score vas used to evaluate pain.The SF 36 test was used to evaluate quality of life.
Other: Visual analogue score
Visual analogue score vas used to evaluate pain.
Other Names:
  • VAS score
Other: The SF 36 test
The SF 36 test (SHORT FORM 36) was used to evaluate quality of life.
Other Names:
  • SHORT FORM 36

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Low back pain after transforaminal epidural steroid injection assessed by VAS scale.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life was evaluated with SF 12 test.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aydin Adnan Menderes University

Investigators

  • Principal Investigator: Fabrizio Galimberti, Medical Student, Cleveland ClinicLernerCollege of Medicine, Cleveland, Ohio
  • Principal Investigator: Osman Nuri Aydın, Prof, Adnan Menderes University Medical Faculty Algology Department
  • Principal Investigator: Banu Taşdemir, Asist Dr, Adnan Menderes University Medical Faculty Anesthesiology and Reanimation Department
  • Principal Investigator: Alparslan Turan, Associate Prof, Department of Outcomes Research, Cleveland Clinic
  • Study Chair: Sinem Sari, Assist Prof, Adnan Menderes University Medical Faculty Anesthesiology and Reanimation Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

June 10, 2014

First Submitted That Met QC Criteria

June 12, 2014

First Posted (Estimate)

June 13, 2014

Study Record Updates

Last Update Posted (Estimate)

June 13, 2014

Last Update Submitted That Met QC Criteria

June 12, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SARI-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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