Clinical trial NCT02162940: Statin and Epidural Steroid Injection
Official title: Effect of Statin Use on Low Back Pain Steroid Injections.
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2014-06-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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).

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).

Eligibility 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

Primary outcomes:
measure: Low back pain after transforaminal epidural steroid injection assessed by VAS scale.
timeFrame: 6 months
Secondary outcomes:
measure: Quality of life was evaluated with SF 12 test.
timeFrame: 6 months
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department
Study officials:
affiliation: Adnan Menderes University Medical Faculty Algology Department
name: Osman Nuri Aydın, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Adnan Menderes University Medical Faculty Anesthesiology and Reanimation Department
name: Banu Taşdemir, Asist Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Cleveland ClinicLernerCollege of Medicine, Cleveland, Ohio
name: Fabrizio Galimberti, Medical Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Outcomes Research, Cleveland Clinic
name: Alparslan Turan, Associate Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Adnan Menderes University Medical Faculty Anesthesiology and Reanimation Department
name: Sinem Sari, Assist Prof
role: STUDY_CHAIR
References:
citation: 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.