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Completed

NCT Number: NCT05626140

COMPARISON OF EFFICACY OF DIFFERENT DRUG COMBINATIONS 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

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Key information

Conditions

Sciatica Acute Mononeuropathies Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Sciatic Neuropathy Sciatica Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mehreen Mirza

Rawalpindi, Punjab Province, 46000, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lacosamide 50 MG Oral Tablet [Vimpat]

Drug

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

Codeine Phosphate

Drug

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

Drug

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

Primary outcomes

  1. Pain Intensity

    Time frame: Patients were asked to mark a line and record their pain scores at baseline and day 5, day 10 and day 15

    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

Secondary outcomes

  1. Functional Disbability

    Time frame: ODI was measured at baseline and days 5,10, and 15 and patients were asked to fill the questionnaire on the respective days

    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

Other outcomes

  1. Use of Rescue Analgesia

    Time frame: The use of rescue medication was determined on the final day of outcome i.e. Day 15

    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

Sponsors and collaborators

Lead sponsor

Pakistan Institute of Medical Sciences

Other Gov

Collaborators

  • Riphah International University

Registry information

Official study title

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

Acronym: EDCLAS

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 23, 2022
Registry last updated
Nov 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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