Health Condition 1: M511- Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy
Conditions
Interventions
Intervention1: â?¢ Duloxetine group (D Group): Group D patients will receive Duloxetine as medication for a trial period of 12 weeks.
Duloxetine will be started as a dose of 30mg once daily in first
Sponsors
Post Graduate Institute of Medical Education and research
Eligibility
Inclusion criteria
Inclusion criteria: Patients with Chronic low back pain (atleast for more than 3 months) with BPI SF average pain intensity score more than 5 and Presence of neuropathic component of pain with pain Detect questionnaire score > 12
Exclusion criteria
Exclusion criteria: 1.Known or suspected serious pathological condition of spine 2.Pregnant or breast feeding females 3.Patients who are planning to undergo spine surgeries or other interventional procedures during trial period 4.Known allergic reaction to the drugs 5.Patients with h/o depression & with suicidal thoughts 6.Patients who are already on antiepileptic and antidepressant medication, and unable to cease taking that medication 7.Severe coexisting diseases (such as heart failure, seizure d/o, kidney functions) 8.Patients who have undergone specialized pain treatment before entering the study. 9.Refusal to participate in study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in worst pain intensity score over previous 24 hours assessed using Brief Pain Inventory (short form)Timepoint: at 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Average pain intensity measured using visual analogue scale (VAS) over previous 24 hours Reduction in neuropathic component of pain using pain detect questionnaire Effect on Quality of life using Short form 36 health survey Reduction in disability using MODQ Effect on mental health using Hospital Anxiety and Depression Scale (HADS) Clinicianâ??s assessment of severity of symptoms using CGI-S Incidence of adverse effects Need for taking rescue medication Timepoint: at baseline, 4 weeks, 8 weeks, 12 weeks | — |
Countries
India
Contacts
Public ContactJeetinder Kaur Makkar
Post Graduate Institute of medical education and research
Outcome results
None listed