Topical Treatments for Ankle Sprains

NCT06623929 | Active Not Recruiting

• 1 other identifier: AEŞH-EK1-2023-750
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Sprain

Keywords

local anesthesia; emergency; Nonsteroidal Anti-Inflammatory Drug; Ankle sprain

Outcome Measures

Primary Outcomes (1)

• Drugs and Pain

  It is the recovery of pain, swelling in the acute phase of ankle sprain.

  0., 1. hour

Secondary Outcomes (1)

• Drugs and movement

  0., and 1. hour

Study Arms (2)

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

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

Interventions

Etofenamat DRUG

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 E

Diclofenac DRUG

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.

Group D

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Ankara, 06170, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ankle Injuries; Emergencies

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: October 2, 2024
• Study Start: January 1, 2024
• Primary Completion: May 1, 2024
• Study Completion: November 1, 2024
• Last Updated: October 2, 2024

Record last verified: 2024-09

Locations

TU (1)