Statin and Epidural Steroid Injection

Low Back Pain After Epidural Steroid Injection Clinical Trial

Official title:

Effect of Statin Use on Low Back Pain Steroid Injections.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02162940
• Other study ID #: SARI-06
• Status: Completed
• Phase: Phase 0
• First received: June 10, 2014
• Last updated: June 12, 2014
• Start date: April 2012
• Est. completion date: December 2013

Study information

• Verified date: June 2014
• Source: Adnan Menderes University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Low Back Pain After Epidural Steroid Injection
• Quality of Life After Epidural Steroid Injection

Intervention

Other:
• Visual analogue score
Visual analogue score vas used to evaluate pain.
• The SF 36 test
The SF 36 test (SHORT FORM 36) was used to evaluate quality of life.

Locations

Country	Name	City	State
Turkey	Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department	Aydin

Sponsors (1)

Lead Sponsor	Collaborator
Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low back pain after transforaminal epidural steroid injection assessed by VAS scale.		6 months	Yes
Secondary	Quality of life was evaluated with SF 12 test.		6 months	Yes