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Clinical Trial 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


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05626140
Study type Interventional
Source Pakistan Institute of Medical Sciences
Contact
Status Completed
Phase Phase 3
Start date September 28, 2021
Completion date July 31, 2022

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