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Statin and Epidural Steroid Injection

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ClinicalTrials.gov Identifier: NCT02162940
Recruitment Status : Completed
First Posted : June 13, 2014
Last Update Posted : June 13, 2014
Sponsor:
Information provided by (Responsible Party):
SINEM SARI, Aydin Adnan Menderes University

Brief 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 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).

Condition or disease Intervention/treatment
Low Back Pain After Epidural Steroid Injection Quality of Life After Epidural Steroid Injection Other: Visual analogue score Other: The SF 36 test

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).

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Study Type : Observational [Patient Registry]
Actual Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Effect of Statin Use on Low Back Pain Steroid Injections.
Study Start Date : April 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


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 Name: VAS score

Other: The SF 36 test
The SF 36 test (SHORT FORM 36) was used to evaluate quality of life.
Other Name: 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 Name: VAS score

Other: The SF 36 test
The SF 36 test (SHORT FORM 36) was used to evaluate quality of life.
Other Name: SHORT FORM 36




Primary Outcome Measures :
  1. Low back pain after transforaminal epidural steroid injection assessed by VAS scale. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Quality of life was evaluated with SF 12 test. [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162940


Locations
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Turkey
Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department
Aydın, Turkey, 09100
Sponsors and Collaborators
Aydin Adnan Menderes University
Investigators
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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: Fabrizio Galimberti, Medical Student Cleveland ClinicLernerCollege of Medicine, Cleveland, Ohio
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
Additional Information:

Publications of Results:
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Responsible Party: SINEM SARI, MD, Assistant Professor, Aydin Adnan Menderes University
ClinicalTrials.gov Identifier: NCT02162940    
Other Study ID Numbers: SARI-06
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: June 13, 2014
Last Verified: June 2014
Keywords provided by SINEM SARI, Aydin Adnan Menderes University:
low back pain
epidural steroid injection
statin
quality of life
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations