COMPARISON OF EFFICACY OF DIFFERENT DRUG COMBINATIONS IN ACUTE SCIATICA

NCT ID: NCT05626140

Last Updated: 2022-11-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-28
• Study Completion Date: 2022-07-31

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Diclofenac plus placebo

Oral tablet diclofeanc sodium 50 mg was given with tab folic acid 5 mg as placebo ,12 hourly for 15 days

Group Type: PLACEBO_COMPARATOR

Diclofenac Sodium

Intervention Type: 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.

Diclofenac plus codeine

Oral tablet diclofeanc sodium 50 mg was given with tab codeinephosphate 30 mg ,12 hourly for 15 days

Group Type: ACTIVE_COMPARATOR

Codeine Phosphate

Intervention Type: 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

Intervention Type: 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.

Diclofenac plus lacosamide

Oral tablet diclofeanc sodium 50 mg was given with tab lacosamide 50 mg as placebo ,12 hourly for 15 days

Group Type: EXPERIMENTAL

Lacosamide 50 MG Oral Tablet [Vimpat]

Intervention Type: 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

Diclofenac Sodium

Intervention Type: 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.

Interventions

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

Intervention Type: 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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Lacolap 50 mg; Vimpat 50 mg; Lalap 50 mg; Artifen 50 mg; Dicloran 50 mg

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: collaborator

Pakistan Institute of Medical Sciences

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Mehreen Mirza

Post Graduate Trainee/ Prinicipal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mehreen Mirza

Rawalpindi, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

PIMS-05-002

Identifier Type: -

Identifier Source: org_study_id