Topical Treatments for Ankle Sprains

Evaluation of Topical Analgesia Treatments for Ankle Sprains

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Ankle Sprain
• Intervention / Treatment: Drug: Etofenamat; Drug: Diclofenac

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06170
    • Ankara Etlik City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Cases presenting to the emergency department with an ankle sprain within the first 48 hours

Description

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.

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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

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Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group E; 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.	Drug: Etofenamat; E group: Etofenamate spray 100 mg/ml 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; 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.	Drug: Diclofenac; Group D: Diclofenac diethylammonium 1% spray 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drugs and Pain	It is the recovery of pain, swelling in the acute phase of ankle sprain.	0., 1. hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drugs and movement	It is the recovery of joint movement functions in the acute phase of ankle sprain.	0., and 1. hour

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): May 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: September 12, 2024
• First Submitted That Met QC Criteria: September 30, 2024
• First Posted (Actual): October 2, 2024

Study Record Updates

• Last Update Posted (Actual): October 2, 2024
• Last Update Submitted That Met QC Criteria: September 30, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: emergency; local anesthesia; Ankle sprain; Nonsteroidal Anti-Inflammatory Drug
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Sprains and Strains; Ankle Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: AEŞH-EK1-2023-750

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No