COMPARISON OF EFFICACY OF DIFFERENT DRUG COMBINATIONS IN ACUTE SCIATICA
Condition: Sciatica Acute; Sciatica
MeSH terms: Sciatica
Study type: Interventional
Phase: Phase 3

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
    

Intervention name(s): Lacosamide 50 MG Oral Tablet [Vimpat]; Codeine Phosphate; Diclofenac Sodium
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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; 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; 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.
Other intervention name(s): Lacolap 50 mg; Vimpat 50 mg; Lalap 50 mg; Artifen 50 mg; Dicloran 50 mg
Intervention MeSH terms: Diclofenac; Lacosamide; Codeine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Acute Sciatica, Codeine, Diclofenac, Efficacy, Lacosamide