Clinical trial NCT05626140: COMPARISON OF EFFICACY OF DIFFERENT DRUG COMBINATIONS IN ACUTE SCIATICA
Official title: COMPARISON OF EFFICACY OF DICLOFENAC VERSUS DICLOFENAC PLUS CODEINE AND DICLOFENAC PLUS LACOSAMIDE IN ACUTE SCIATICA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sciatica Acute
Sciatica
Keywords: Acute Sciatica, Codeine, Diclofenac, Efficacy, Lacosamide
Lead sponsor: Pakistan Institute of Medical Sciences
Sponsor class: OTHER_GOV
Collaborators: name: Riphah International University
First posted: 2022-11-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Pain Intensity
timeFrame: Patients were asked to mark a line and record their pain scores at baseline and day 5, day 10 and day 15
Secondary outcomes:
measure: Functional Disbability
timeFrame: ODI was measured at baseline and days 5,10, and 15 and patients were asked to fill the questionnaire on the respective days
Other outcomes:
measure: Use of Rescue Analgesia
timeFrame: The use of rescue medication was determined on the final day of outcome i.e. Day 15
Locations:
city: Rawalpindi
country: Pakistan
facility: Mehreen Mirza
state: Punjab
Study officials:
References: