Health Condition 1: M545- Low back pain
Conditions
Interventions
Intervention1: Pregablin plus Nortriptyline: Pregabalin 75 mg plus Nortriptyline 10 mg HS for 12 weeks
Control Intervention1: Pregabalin plus Duloxetine: Pregabalin 75 mg plus Duloxetine 20 mg HS for
Sponsors
Dr Vignesh Kumar
Eligibility
Inclusion criteria
Inclusion criteria: Adults aged 18 60 years Patients clinically diagnosed with chronic low back pain persisting for greator than or equal to 3 months VAS score greator than or equal to 5 out of 10 at baseline No specific structural cause of low back pain on imaging examples like no fracture or infection or malignancy Willingness to participate and provide written informed consent Patient refractory to NSAIDS and opioids for more than 3 months and pregabalin alone
Exclusion criteria
Exclusion criteria: Specific pathological causes of back pain such as infection or malignancy or fracture or rheumatoid arthritis or seronegative arthritis or spinal tumors or vascular malformations History of spinal surgery or severe neurological deficit or cauda equina syndrome Pregnancy or lactation Uncontrolled comorbidities such as cardiac disorders advanced diabetes mellitus hypertension chronic kidney disease chronic liver disease History of depression or psychiatric illness requiring antidepressant treatment in the past 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Responder Rate greator than or equal to 30 percent reduction in pain intensity using VASTimepoint: At baseline 4 weeks and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare functional improvement measured by the Oswestry Disability Index ODI and Roland-Morris Disability Questionnaire RMDQ Timepoint: From baseline to 12 weeks ;To assess safety based on adverse effects associated with above mentioned drugsTimepoint: From baseline to 12 weeks | — |
Countries
India
Contacts
Public ContactDr Vignesh Kumar
All India Institute Of Medical Sciences vijaypur jammu 184120
Outcome results
None listed