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

Pakistan Institute of Medical Sciences

Status and phase: Completed; Phase 3

Conditions: Sciatica; Sciatica Acute

Treatments: Drug: Lacosamide 50 MG Oral Tablet [Vimpat]; Drug: Codeine Phosphate; Drug: Diclofenac Sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT05626140

PIMS-05-002

Details and patient eligibility

About

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

Full 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

Enrollment: 120 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups, including a placebo group

Diclofenac plus placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Diclofenac Sodium

Diclofenac plus codeine

Active Comparator group

Description:

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

Treatment:

Drug: Codeine Phosphate

Drug: Diclofenac Sodium

Diclofenac plus lacosamide

Experimental group

Description:

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

Treatment:

Drug: Diclofenac Sodium

Drug: Lacosamide 50 MG Oral Tablet [Vimpat]