MedPath

Agomelatin in chronic low back pai

Phase 3
Recruiting
Conditions
Chronic low back pain.
Low back pain
M54.5
Registration Number
IRCT20200620047852N1
Lead Sponsor
Iran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
84
Inclusion Criteria

Patients with chronic low back pain without an indication for surgery.Chronic low back pain+patients with low back pain for at least 3 months(almost everyday)
Patients aged between 18 to 60

Exclusion Criteria

Patiens with long term usage of Opioids , Anti depressants , Benzodiazepines,Gabaergic drugs
Any contraindications for using each drugs(Agomelatin or Pregabalin)
Liver enzymes three times more than normal
Patients with depression disorder or suicidal thoughts or psychosis or acute manic phase or cognitive disorder or anxiety disorder or PTSD who needs treatment. These patients will exclude by an interview done by an educated psycholoy resident due to DSM5
Patients who need surgery will exclude
PAtients who are taling any Anti-depressants drugs
Patients who took Pregabalin within 1 month
Patients who are taking physiotherapy courses will exclude
Life expectancy under 12 month
Patients who are pregnant or during breastfeeding period

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Score of pain in brief pain inventory scale (BPI) questionnaire. Timepoint: The beginning of the the study and 1st,4th,8th week. Method of measurement: Brief pain inventory scale (BPI) questionnaire.
Secondary Outcome Measures
NameTimeMethod
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