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Completed

NCT Number: NCT02162940

Statin and Epidural Steroid Injection

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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Key information

Conditions

Low Back Pain After Epidural Steroid Injection Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Quality of Life After Epidural Steroid Injection Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department

Aydin, 09100, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Visual analogue score

Other

Visual analogue score vas used to evaluate pain.

Other names: VAS score

The SF 36 test

Other

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

Other names: SHORT FORM 36

Primary outcomes

  1. Low back pain after transforaminal epidural steroid injection assessed by VAS scale.

    Time frame: 6 months

Secondary outcomes

  1. Quality of life was evaluated with SF 12 test.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Official study title

Effect of Statin Use on Low Back Pain Steroid Injections.

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 13, 2014
Registry last updated
Jun 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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