NCT05626140

COMPARISON OF EFFICACY OF DIFFERENT DRUG COMBINATIONS IN ACUTE SCIATICA

COMPARISON OF EFFICACY OF DICLOFENAC VERSUS DICLOFENAC PLUS CODEINE AND DICLOFENAC PLUS LACOSAMIDE IN ACUTE SCIATICA

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Pakistan Institute of Medical Sciences · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare different combinations of diclofenac with diclofenac monotherapy in acute sciatica. The main questions it aims to answer are: * Does the combination of diclofenac plus codeine better than diclofenac monotherapy for treating severe pain of sciatica * Does the combination of diclofenac plus lacosamide better than diclofenac monotherapy for treating severe pain of sciatica Participants will be asked to mark their pain intensity on a visual analog scale and fill oswestry disabilit index questionnaire,treatments they'll be given includes either 1. Diclofenac monotherapy 2. Diclofenac plus codeine 3. Diclofenac plus lacosamide Researchers will compare the above three groups to see if severity of pain and disability lowered after medication

Detailed description

Musculoskeletal conditions are the most common cause of intense long-term pain, physical disability and early deaths. They affect hundreds of millions of people of all ages irrespective of social strata globally. Lumbar radicular pain (LRP), commonly referred to as "Sciatica" is a relatively common musculoskeletal disorder. Objective of the study is to evaluate the efficacy of different drug combinations with diclofenac for the treatment of acute sciatica. The design of the study is Single-center, clinical trial with three arms. (Single Blinding). One hundred and twenty patients were enrolled in this study between September 2021 and July 2022 at the Pharmacology department of Islamic International Medical College (IIMC) Rawalpindi in collaboration with the Neurosurgery Department, of Shaheed Zulfiqar Ali Bhutto Medical University (SZABMU) Pakistan Institute of Medical Sciences (PIMS) Islamabad. Informed verbal and written consent was taken from all patients. 40 patients were in the diclofenac (50 mg) plus placebo group, 40 in the codeine (30 mg) plus diclofenac (50 mg) group and 40 in lacosamide (50 mg) plus diclofenac (50 mg) group. Patients were followed up at day 5, 10 and 15 to assess change in pain intensity and functional disability. The use of rescue analgesia was also assessed at the final day of outcome

Conditions

• Sciatica Acute
• Sciatica

Interventions

Type	Name	Description
DRUG	Lacosamide 50 MG Oral Tablet [Vimpat]	Oral tablet lacosamide is a 3rd generation anti convulsant drug. it is given in a dose of 50 mg 12 hourly for 15 days. It has a longer half life than the other two drugs in comparison and fewer drug interactions as it doesnot interact with the hepatic cytochrome enzymes.hence it is seen to have better pharmacokinetics and pharmacodynamics than the other drugs in study
DRUG	Codeine Phosphate	Oral Codeine Phophate is an opioid with centrally acting pain alleviating mechanisms, shorter half life and metabolized to morphine in he body which is its active metabolite
DRUG	Diclofenac Sodium	Diclofenac sodium is a Cox 2 inhibitor non steroidal anti inflammatory drug with a half life of only 1.2 hrs but a longer action of duration due to its property to get distributed to synovial fluids. metabolized to hydroxy diclofenac and excreted via urine and bile both.

Timeline

• Start date: 2021-09-28
• Primary completion: 2022-05-31
• Completion: 2022-07-31
• First posted: 2022-11-23
• Last updated: 2022-11-23

Locations

1 site across 1 country: Pakistan