Statin and Epidural Steroid Injection

Study Overview
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Brief Summary
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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
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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).

Official Title
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Effect of Statin Use on Low Back Pain Steroid Injections.

Conditions
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Low Back Pain After Epidural Steroid Injection, Quality of Life After Epidural Steroid Injection

Intervention / Treatment
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* Other: Visual analogue score
* Other: The SF 36 test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients taking statins<br>Visual anlogue score vas used to evaluate pain. The SF 36 test was used to evaluate quality of life. | Other: Visual analogue score<br>* Visual analogue score vas used to evaluate pain.<br>* Other names: VAS score;Other: The SF 36 test<br>* The SF 36 test (SHORT FORM 36) was used to evaluate quality of life.<br>* Other names: SHORT FORM 36;|
| patients not taking statins<br>Visual anlogue score vas used to evaluate pain.The SF 36 test was used to evaluate quality of life. | Other: Visual analogue score<br>* Visual analogue score vas used to evaluate pain.<br>* Other names: VAS score;Other: The SF 36 test<br>* The SF 36 test (SHORT FORM 36) was used to evaluate quality of life.<br>* Other names: SHORT FORM 36;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low back pain, epidural steroid injection, statin, quality of life