Ankle SprainNCT06623929
Topical Treatments for Ankle Sprains
An observational study of Ankle Sprain, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ankle Sprain
- What is being tested?
- Etofenamat and Diclofenac
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cases presenting to the emergency department with an ankle sprain within the first 48 hours
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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Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Ankara, Ankara, 06170
About this study
Official title: 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.
- Conditions
- Ankle Sprain
- Being tested
- Etofenamat, Diclofenac
- Keywords
- local anesthesia, emergency, Nonsteroidal Anti-Inflammatory Drug, Ankle sprain
- Medical subject headings
- Ankle Injuries, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtofenamatDrug
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.
DiclofenacDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drugs and Pain
It is the recovery of pain, swelling in the acute phase of ankle sprain.
Measured: 0., 1. hour
Secondary outcomes (1)
Drugs and movement
It is the recovery of joint movement functions in the acute phase of ankle sprain.
Measured: 0., and 1. hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start1 Jan 2024
- Primary completion1 May 2024
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Kaya Çelikel, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623929
- Sponsor's protocol ID
- AEŞH-EK1-2023-750
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Topical Analgesia Treatments for Ankle Sprains
- ClinicalTrials.gov ID
- NCT06623929
- Acronym / sponsor ID
- AEŞH-EK1-2023-750
- Conditions
- Ankle Sprain
- Keywords
- local anesthesia, emergency, Nonsteroidal Anti-Inflammatory Drug, Ankle sprain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group E | – | Drug: EtofenamatGroup 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 | – | Drug: DiclofenacGroup 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cases presenting to the emergency department with an ankle sprain within the first 48 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtofenamatE 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. | Drug | Group E |
| DiclofenacGroup 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. | Drug | Group D |
Primary outcome
Drugs and Pain
Time frame: 0., 1. hour
It is the recovery of pain, swelling in the acute phase of ankle sprain.
1 secondary outcome
Drugs and movement
Time frame: 0., and 1. hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Sprain, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drugs and Pain (time frame: 0., 1. hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.