Topical Treatments for Ankle Sprains

Active, not recruiting

• Conditions: Ankle Sprain
• Interventions: Drug: Etofenamat; Drug: Diclofenac

• Registration Number: NCT06623929
• Lead Sponsor: Ankara City Hospital Bilkent

Brief Summary

Our aim was to evaluate the effects of topical analgesic drugs on rapid recovery of joint functions and pain relief in acute ankle injuries.

A total of 100 patients were included in the study and divided into 2 groups as Diclofenac and Etofenamate. The pain scores of the patients were evaluated with the Numeric Rating scale and Wong-Baker scale before and after treatment. Dorsiflexion and plantarflexion active joint movements were measured with a hand-held goniometer for joint function before and after treatment.

We found that ankle sprains were more common in men. In our study, we found that both topical analgesics were effective in improving joint movements and reducing pain.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Primary Completion: 2024-05-01
• Status Verified: 2024-09
• Study First Submitted: 2024-09-12
• Study First Submitted QC: 2024-09-30
• Last Update Submitted: 2024-09-30
• Study First Posted: 2024-10-02
• Last Update Posted: 2024-10-02
• Study Completion: 2024-11-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Those over the age of 18, who applied to the emergency room within the first 48 hours after an ankle sprain, who have grade 1/mild and grade 2/moderate ankle sprains, who have excluded fractures and dislocations, who have no muscle-tendon ruptures, no vascular or nerve injuries, no open wounds or burns, whose vital signs are stable, and who give written and verbal consent.

Exclusion Criteria

Those who did not present within the first 48 hours of ankle sprain, grade 3/severe ankle sprain, multiple trauma, pregnancy, suspected pregnancy, foot and ankle fractures and dislocations, those who had a previous ankle operation or fracture, and cases who did not accept to participate in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group E	Etofenamat	Group E, Etofenamate spray 100 mg/ml (Flexo 100 mg/ml-Kocaeli) is applied to the painful area from a distance of approximately 10-15 cm in a maximum of 7 puffs. Each puff contains 18 mg etofenamate.
Group D	Diclofenac	Group D Diclofenac diethylammonium 1% spray (Painout Ice 1%-Ankara) was applied to the painful area from a distance of approximately 10-15 cm in a maximum of 6 puffs. Each puff contained 5.8 mg diclofenac diethylammonium.

Primary Outcome Measures

Name	Time	Method
Drugs and Pain	0., 1. hour	It is the recovery of pain, swelling in the acute phase of ankle sprain.

Secondary Outcome Measures

Name	Time	Method
Drugs and movement	0., and 1. hour	It is the recovery of joint movement functions in the acute phase of ankle sprain.

Trial Locations

Locations (1)

Ankara Etlik City Hospital; 🇹🇷 Ankara, Turkey