NCT02162940

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 13, 2014

Completed
Last Updated

June 13, 2014

Status Verified

June 1, 2014

Enrollment Period

1.7 years

First QC Date

June 10, 2014

Last Update Submit

June 12, 2014

Conditions

Low Back Pain After Epidural Steroid InjectionQuality of Life After Epidural Steroid Injection

Keywords

low back painepidural steroid injectionstatinquality of life

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (1)

  • Quality of life was evaluated with SF 12 test.

    6 months

Study Arms (2)

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 scoreOther: The SF 36 test

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 scoreOther: The SF 36 test

Interventions

Visual analogue scoreOTHER

Visual analogue score vas used to evaluate pain.

Also known as: VAS score
patients not taking statinspatients taking statins
The SF 36 testOTHER

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

Also known as: SHORT FORM 36
patients not taking statinspatients taking statins

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • indication for TAESI given by blinded pain physician

You may not qualify if:

  • known allergy to steroids
  • indication for surgery
  • unstable opioid use
  • drug or alcohol abuse within 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department

Aydin, 09100, Turkey (Türkiye)

Location

Related 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.

    PMID: 23887344RESULT

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

  • Sinem Sari, Assist Prof

    Adnan Menderes University Medical Faculty Anesthesiology and Reanimation Department

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Assistant Professor

Study Record Dates

First Submitted

June 10, 2014

First Posted

June 13, 2014

Study Start

April 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

June 13, 2014

Record last verified: 2014-06

Locations

TU(1)