COMPARISON OF EFFICACY OF DIFFERENT DRUG COMBINATIONS IN ACUTE SCIATICA (EDCLAS)

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

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

Study Overview

• Status: Completed
• Conditions: Sciatica; Sciatica Acute
• Intervention / Treatment: Drug: Diclofenac Sodium; Drug: Codeine Phosphate; Drug: Lacosamide 50 MG Oral Tablet [Vimpat]

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

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 46000
      • Mehreen Mirza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients diagnosed with acute sciatica with or without lower back pain
• 18-70 years of age reporting acute pain due to sciatica

Exclusion Criteria:

• Pregnant or breastfeeding mothers.
• History of asthma or allergy to anti-inflammatory drugs.
• Mentally handicapped or terminally ill patients.
• Age less than 18 years or above 70 years
• Patients with herniated, sequestrated, or prolapsed discs waiting for surgery.
• Patient having an active ulcer (gastric or duodenal) or bleeding from the stomach or bowel.
• Patients already taking an anti-depressant medication, a medication for neuropathic pain, an anticonvulsant, or a sedative and unable to cease the medication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Diclofenac plus placebo; Oral tablet diclofeanc sodium 50 mg was given with tab folic acid 5 mg as placebo ,12 hourly for 15 days	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.; Other Names: Artifen 50 mg; Dicloran 50 mg
Active Comparator: Diclofenac plus codeine; Oral tablet diclofeanc sodium 50 mg was given with tab codeinephosphate 30 mg ,12 hourly for 15 days	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.; Other Names: Artifen 50 mg; Dicloran 50 mg; 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
Experimental: Diclofenac plus lacosamide; Oral tablet diclofeanc sodium 50 mg was given with tab lacosamide 50 mg as placebo ,12 hourly for 15 days	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.; Other Names: Artifen 50 mg; Dicloran 50 mg; 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; Other Names: Lacolap 50 mg; Vimpat 50 mg; Lalap 50 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	Severity of leg pain or lower back pain associated with acute sciatica to be assessed using the visual analog scale VAS to determine if the mean pain scores decreased during the course of the medication. VAS is a commonly used pain score in interventinal studies and evaluating pain intensity related with musculoskeletal disorders or post opertive types of pain. For this , the patient is asked to mark a line anywhere on a 10 cm line with 0 taken on the left edge. The mark drawn on the line corresponds to the intensity pf pain experienced by the patient at the time of the pain assessment	Patients were asked to mark a line and record their pain scores at baseline and day 5, day 10 and day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Disbability	The ODI is an index derived from the Oswestry Low Back Pain Questionnaire. The self-administered questionnaire consists of ten topics related to intensity of pain, lifting, ability of self-care, potential to walk, capacity to sit, sexual function, strength to stand, social life, quality of sleep, and capability to travel. Each category (topic) is then followed by 6 statements relating different potential scenarios in the patient's life concerning to the topic. Patients are inquired to specify the statement that most strictly is similar to their situation. Statements are linked with scores from 0 to 5, where 0 represents the lowest disability and 5 equivalent to extreme disability. The sum of the ten scores is stated as a percentage of the maximum score (50) ranging from 0% = no disability to 100% = maximum disability	ODI was measured at baseline and days 5,10, and 15 and patients were asked to fill the questionnaire on the respective days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of Rescue Analgesia	This parameter was evaluated if the patient used rescue medication (YES or NO) in case the pain did not improve or settle with the medicines already given to the patient	The use of rescue medication was determined on the final day of outcome i.e. Day 15

Collaborators and Investigators

• Sponsor: Pakistan Institute of Medical Sciences
• Collaborators: Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2021
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: November 15, 2022
• First Posted (Actual): November 23, 2022

Study Record Updates

• Last Update Posted (Actual): November 23, 2022
• Last Update Submitted That Met QC Criteria: November 15, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Acute Sciatica, Codeine, Diclofenac, Efficacy, Lacosamide
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuralgia; Sciatica; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Analgesics, Opioid; Narcotics; Membrane Transport Modulators; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Respiratory System Agents; Antitussive Agents; Lacosamide; Diclofenac; Codeine
• Other Study ID Numbers: PIMS-05-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No