Effectiveness of duloxetine in chronic low back pai

Phase 3

Conditions: Effectiveness of duloxetine in posterior spinal fixation.

Registration Number: IRCT20191210045685N1

Lead Sponsor: Iran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 50

Inclusion Criteria

Patients older than 18 years old and younger than 80 with chronic low back pain (more than 3 months duration) who are candidate for posterior spinal fixation surgery.
All patients have to discontinue any medication that could interfere with their pain such as nonopioid or opioid drugs , antidepressants and anticonvulsants at least for 6 months before surgery.
Non pharmacological pain-relieving procedures such as acupuncture or physical therapies are not allowed during the study.

Exclusion Criteria

prior use of opioids , antidepressants , drug abuse
depression
pregnancy and breast feeding
severe coexisting diseases such as heart failure , severe hypertension , convulsion and kidney dysfunction

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effectiveness of duloxetine on quality of life in chronic low back pain in patients who had posterior spinal fixation measured with SF36 questionnaire / Effectiveness of duloxetine on severity of pain in chronic low back pain in patients who had posterior spinal fixation measured with VAS questionnaire. Timepoint: all patients will fill the questionnaires at first step of study and one more 6 weeks later. Method of measurement: SF36 questionnaire / VAS questionnaire.

Secondary Outcome Measures