Comparing effect of two medications pregabalin and duloxetine for tingling and numbness in patients with long lasting low back pai
- Conditions
- Health Condition 1: M511- Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy
- Registration Number
- CTRI/2022/05/042387
- Lead Sponsor
- Post Graduate Institute of Medical Education and research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in worst pain intensity score over previous 24 hours assessed using Brief Pain Inventory (short form)Timepoint: at 12 weeks
- Secondary Outcome Measures
Name Time Method Average pain intensity measured using visual analogue scale (VAS) over previous 24 hours <br/ ><br>Reduction in neuropathic component of pain using pain detect questionnaire <br/ ><br>Effect on Quality of life using Short form 36 health survey <br/ ><br>Reduction in disability using MODQ <br/ ><br>Effect on mental health using Hospital Anxiety and Depression Scale (HADS) <br/ ><br>Clinicianâ??s assessment of severity of symptoms using CGI-S <br/ ><br>Incidence of adverse effects <br/ ><br>Need for taking rescue medication <br/ ><br>Timepoint: at baseline, 4 weeks, 8 weeks, 12 weeks