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A clinical trial to study the effects of two drugs, ibuprofen and pregabalin in patients with acute back pain with leg pain

Efficacy of Pregabalin for treatment of acute lumbar radicular pain: RCT on central Indian rural population

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/08/026968
Enrollment
62
Registered
2020-08-04
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M511- Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy

Interventions

Intervention1: Tablet Pregabalin: Oral tablet Pregabalin 75 mg two times a day for 30 days will be given Control Intervention1: tablet Ibuprofen: Oral Tablet Ibuprofen 400 mg two times a day for 30 da

Sponsors

Mahatma Gandhi Institute of medical sciences sevagram wardha
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient having lumbar disc herniation on MRI lumbar spine 2. Patient between age 20 to 60 years 3. The duration of symptoms should be less than 14 days. 4. Neuropathic Pain-Screening Questionnaire developed by Ogawa et al will be used and only those patients who have score of greater than 5 will be included in the study. 5. Patient giving consent for treatment.

Exclusion criteria

Exclusion criteria: 1. Patient with significant motor weakness, myelopathy signs, bowel or bladder involvement 2. Pathology involving vertebral body (tumor, fracture) 3. Previous spine surgery 4. Patient having renal dysfunction, ischemic heart disease, previous intolerance to NSAIDS or Pregabalin, psychiatric disorder. 5. Pregnant or Breastfeeding mother

Design outcomes

Primary

MeasureTime frame
Patient will be evaluated at 0, 2 and 4 weeks using Visual analogue scale pain score, Revised Oswestry disability index, and Patient Global impression of change (PGIC) score, Clinical global impression of change score.Timepoint: base line (i.e on first day), 2 weeks and 4 weeks

Secondary

MeasureTime frame
Visual analogue scale sleep score.Timepoint: measured at 0, 2 and 4 weeks

Countries

India

Contacts

Public ContactDr Prasheelkumar Gupta

Mahatma Gandhi Institute of Medical Sciences, Sevagram

prasheelgupta@gmail.com9167611788

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026