A study to compare the effectiveness of two different types of painkiller topical formulations

Phase 4

Completed

• Conditions: Patients suffering from acute musculoskeletalpainful conditions

• Registration Number: CTRI/2018/04/013316
• Lead Sponsor: Armed Forces Medical College Pune

Brief Summary

This is a Prospective,randomized, clinical trial to compare efficacy of two topical formulations of Diclofenac Diethylamine in the Treatment of Acute Painful Musculoskeletal Conditions being carried out in a tertiary care centre of Pune. Patients with acute musculo-skeletal pain (total of 140) are being randomise in to two groups and given the two above mentioned formulations. The primary and secondary objectives mentioned before are assessed using VAS and other scales as mentioned in the methodology. The measurements of the same are being carried out on Day 3 and 7 of the intervention.Results will be tabulated,statistically analysed and forwarded.



Results:

Both the topical formulations of diclofenac were found to be effective and safe in management in acute painful musculoskeletal conditions when compared with baseline assessment. However, topical solution of diclofenac 4.64% w/v was superior to diclofenac topical gel 1.16% w/w in the both primary and secondary efficacy endpoints. The pain intensity difference was significantly lesser with Diclofenac topical 4.64% topical solution as compared to diclofenac topical gel 1.16% w/w on day 3 (P < 0.05) and day 7 (P < 0.05). Further, it was observed that, there was more proportion of groups B patients (22.85%) who required rescue analgesia when treated with topical diclofenac gel as compared to group A patients (1.42%) treated with Diclofenac topical 4.64% topical solution.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-09
• Study Completion: 2017-01-12
• Last Update Posted: 2018-02-17

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

All adult patients with acute painful musculoskeletal pain.

Exclusion Criteria

• All patients denying consent to participate in the trial 2.
• All patients with deep abrasions and lacerations around the area of affliction 3.
• Individuals with known adverse reaction to topical Diclofenac preparations.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain intensity difference (PID) from baseline (before starting treatment) during movement (of affected area) and at rest	Day 3 and 7

Secondary Outcome Measures

Name	Time	Method
1.Requirement of oral analgesics	2. Side effects

Trial Locations

Locations (1)

Armed Forces Medical College; 🇮🇳 Pune, MAHARASHTRA, India

Armed Forces Medical College

🇮🇳Pune, MAHARASHTRA, India

Vivek Mathew Philip

Principal investigator

02026026019

vivekphilip121@yahoo.com