Ankle Fractures3-armRCTNCT06293209
Effect of Cool Spray and Cold Packs in Reducing Preoperative Edema and Pain in Ankle Fractures in Ubonratchathani
A study testing 3M cold pack and Perskindol cold spray in people with Ankle Fractures and Swelling, run by Thai Traditional Medical Knowledge Fund at 1 site in Thailand.
Trial summary
The use of evaporative coolants in the management of acute musculoskeletal injury has received increasing attention recently. However, its efficacy compared with conventional cryotherapy in treating injured human subjects remains unclear. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ankle Fractures, Swelling, Cryotherapy Effect
- What is being tested?
- 3M cold pack and Perskindol cold spray
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteThailand
- Study dates
- 1 Aug 2023to 28 May 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Thai male and female individuals
- aged 18 years or older.
- diagnosed by the researcher as having unimalleolar fracture, bimalleolar fracture, or trimalleolar fracture requiring surgery.
- capable of reading and writing in the Thai language.
Who cannot join
- - Fractures in both ankles.
- Pathologic fractures of the ankle bones.
- Simultaneous fractures of the ankle and leg bones.
- Previous history of ankle fractures.
- Nerve-related disorders causing inflammation around the ankle.
- Peripheral artery disease causing blockages in the leg arteries.
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- Infections in the ankle area.
- Cold allergy.
- Inability to read and write in the Thai language
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Orthopedics, Sunpasitthiprasong hospital, Ubonratchathani, Thailand.
Multiple Locations, Ubonrachathani, 34000
About this study
Official title: Effect of Cool Spray and Cold Packs in Reducing Preoperative Edema and Pain in Ankle Fractures in Ubonratchathani: 3-arm Parallel-group RCT
The use of evaporative coolants in the management of acute musculoskeletal injury has received increasing attention recently. However, its efficacy compared with conventional cryotherapy in treating injured human subjects remains unclear.
The purpose of this study is to compare the efficacy of evaporative coolants with that of ice packs in the preoperative management of edema and pain in patients with an ankle fracture
Read the detailed description
Fractures of the ankle bone are one of the common types of bone fractures found in the general population, accounting for approximately 14% of all fractures They are often found in middle-aged males aged 15-24 years who engage in high-impact physical activities such as sports or high-intensity exercise. They are also found in elderly females with osteoporosis aged 75-84 years The incidence of ankle fractures is 187 per 100,000 population per year Ankle bone fractures usually occur due to excessive force or weight bearing. The main causes of ankle bone fractures can be categorized into three age groups: falls account for up to 61% in the elderly population, sports injuries or repetitive movements in sports or exercises can lead to pain, swelling, and bruising around the ankle joint, or the ankle may appear deformed, which is commonly found in younger age groups, accounting for 22%, and accidents from motor vehicle collisions account for 17% Unimalleolar ankle fractures are the most common type, accounting for 70% of all ankle fractures. Bimalleolar fractures account for approximately 20%, while trimalleolar fractures account for about 7% of all ankle fractures Initial management of ankle injuries involves using the RICE approach, which includes applying ice (I = ice) to the injured area. Cooling the skin with ice packs is a widely used traditional method of caring for injured patients. It has been found that when the skin temperature of bruised areas is reduced below 13.6 degrees Celsius with ice packs, swelling and pain in ankle injuries can be effectively reduced Prolonged use of ice packs for more than 6 days after injury can delay surgery and accelerate tissue recovery after surgery Additionally, studies comparing the effectiveness of reducing swelling in ankle tissue injuries with cold spray and ice packs have found that cold spray is 2-3 times more effective than ice packs in reducing swelling and pain in patients with ankle fractures both before and after surgery However, there has been no study in Thailand on effective cooling methods to reduce swelling and alleviate pain in ankle fractures. Therefore, this research aims to compare the effectiveness of using ice packs and cold spray in reducing swelling and pain before surgery in patients with ankle fractures treated at Sunpasitthiprasong Hospital, Ubon Ratchathani. It is hypothesized that cooling with ice packs and cold spray is effective in reducing swelling and pain in patients with ankle fractures before surgery, and that the effectiveness of ice packs and cold spray in reducing swelling and pain in patients with ankle fractures before surgery differs. This study aims to provide data for developing effective methods and guidelines to reduce swelling and pain in patients with ankle fractures before surgery and may be applied as an alternative option to reduce swelling and pain in patients with fractures in other parts of the body.
- Conditions
- Ankle Fractures, Swelling, Cryotherapy Effect
- Being tested
- 3M cold pack, Perskindol cold spray, Placebo
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3M cold packDevice
Also called cold pack
3M cold pack
Perskindol cold sprayDevice
Also called cold spray
Perskindol cold spray
PlaceboDevice
Also called non-cryotherapy treatment
Placebo
| Study group | Role | What they receive |
|---|---|---|
| The control group (non-cryotherapy group) | Placebo comparator | Routine preoperative protocol ankle fracture on short leg slab compression with bandage Receives: Device: Placebo |
| The cold pack group | Active comparator | The cold pack group consists of patients with ankle fractures who receive cold therapy using ice packs sized 20x20 centimeters. The ice packs are placed in the freezer compartment for 30 seconds after they have solidified, then applied to the injured ankle for 10 minutes, followed by a 10-minute break. This process is repeated every 2 hours for a total of 6 times (from 8:00 AM to 6:00 PM). Receives: Device: 3M cold pack |
| The cold spray | Active comparator | The cold spray group consists of patients with ankle fractures who receive cold therapy using Perskindol cold spray containing Levomenthol. The spray is applied to the injured ankle 5-6 times, followed by a 10-minute break. This process is repeated every 2 hours for a total of 6 times (from 8:00 AM to 6:00 PM). Receives: Device: Perskindol cold spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
swelling
Measuring ankle swelling using the figure-of-eight-20 method, which involves measuring the circumference of the ankle and foot using a tape measure placed along the sides of the foot, passing through specific points,3 time and then averaging the measurements obtained in millimeters.
Measured: 5 day before surgery
Secondary outcomes (1)
pain score
Assessing pain levels using the Visual Analog Scale (VAS), a 10-centimeter horizontal line labeled with "no pain at all" at one end and "unbearable pain" at the other. Participants mark their pain level on the scale from 0 to 10, and pain severity is categorized into 5 levels: no pain (0 points), mild pain (1-3 points), moderate pain (4-6 points), severe pain (7-9 points), and extreme pain (10 points).
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start1 Aug 2023
- Primary completion28 Feb 2024 (estimated)
- Study completion28 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle FracturesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Population The sample group comprises 30 patients admitted for treatment in the male orthopedic surgery department, female orthopedic surgery department, and accident orthopedic surgery department at Sunpasitthiprasong Hospital, Ubon Ratchathani from August 2023 to January 2024. .
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thai Traditional Medical Knowledge Fund
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Watcharachai Potad, Thai Traditional Medical Knowledge Fund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293209
- Sponsor's protocol ID
- Sunpasitthiprasong Hospital
- Other IDs
- Sunpasitthiprasong Hospital
- Acronym
- 3-armRCT
- Status last verified
- Feb 2024
- First submitted
- 19 Feb 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cool Spray and Cold Packs in Reducing Preoperative Edema and Pain in Ankle Fractures in Ubonratchathani: 3-arm Parallel-group RCT
- ClinicalTrials.gov ID
- NCT06293209
- Acronym / sponsor ID
- 3-armRCT / Sunpasitthiprasong Hospital
- Conditions
- Ankle Fractures, Swelling, Cryotherapy Effect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Thai Traditional Medical Knowledge FundOther government
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 28 May 2024 (estimated)
- First posted
- 5 Mar 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.
The use of evaporative coolants in the management of acute musculoskeletal injury has received increasing attention recently. However, its efficacy compared with conventional cryotherapy in treating injured human subjects remains unclear.
The purpose of this study is to compare the efficacy of evaporative coolants with that of ice packs in the preoperative management of edema and pain in patients with an ankle fracture
Detailed description
Fractures of the ankle bone are one of the common types of bone fractures found in the general population, accounting for approximately 14% of all fractures They are often found in middle-aged males aged 15-24 years who engage in high-impact physical activities such as sports or high-intensity exercise. They are also found in elderly females with osteoporosis aged 75-84 years The incidence of ankle fractures is 187 per 100,000 population per year Ankle bone fractures usually occur due to excessive force or weight bearing. The main causes of ankle bone fractures can be categorized into three age groups: falls account for up to 61% in the elderly population, sports injuries or repetitive movements in sports or exercises can lead to pain, swelling, and bruising around the ankle joint, or the ankle may appear deformed, which is commonly found in younger age groups, accounting for 22%, and accidents from motor vehicle collisions account for 17% Unimalleolar ankle fractures are the most common type, accounting for 70% of all ankle fractures. Bimalleolar fractures account for approximately 20%, while trimalleolar fractures account for about 7% of all ankle fractures Initial management of ankle injuries involves using the RICE approach, which includes applying ice (I = ice) to the injured area. Cooling the skin with ice packs is a widely used traditional method of caring for injured patients. It has been found that when the skin temperature of bruised areas is reduced below 13.6 degrees Celsius with ice packs, swelling and pain in ankle injuries can be effectively reduced Prolonged use of ice packs for more than 6 days after injury can delay surgery and accelerate tissue recovery after surgery Additionally, studies comparing the effectiveness of reducing swelling in ankle tissue injuries with cold spray and ice packs have found that cold spray is 2-3 times more effective than ice packs in reducing swelling and pain in patients with ankle fractures both before and after surgery However, there has been no study in Thailand on effective cooling methods to reduce swelling and alleviate pain in ankle fractures. Therefore, this research aims to compare the effectiveness of using ice packs and cold spray in reducing swelling and pain before surgery in patients with ankle fractures treated at Sunpasitthiprasong Hospital, Ubon Ratchathani. It is hypothesized that cooling with ice packs and cold spray is effective in reducing swelling and pain in patients with ankle fractures before surgery, and that the effectiveness of ice packs and cold spray in reducing swelling and pain in patients with ankle fractures before surgery differs. This study aims to provide data for developing effective methods and guidelines to reduce swelling and pain in patients with ankle fractures before surgery and may be applied as an alternative option to reduce swelling and pain in patients with fractures in other parts of the body.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Population The sample group comprises 30 patients admitted for treatment in the male orthopedic surgery department, female orthopedic surgery department, and accident orthopedic surgery department at Sunpasitthiprasong Hospital, Ubon Ratchathani from August 2023 to January 2024. .
| Arm | Type | Receives |
|---|---|---|
| The control group (non-cryotherapy group) | Placebo comparator | Device: PlaceboRoutine preoperative protocol ankle fracture on short leg slab compression with bandage |
| The cold pack group | Active comparator | Device: 3M cold packThe cold pack group consists of patients with ankle fractures who receive cold therapy using ice packs sized 20x20 centimeters. The ice packs are placed in the freezer compartment for 30 seconds after they have solidified, then applied to the injured ankle for 10 minutes, followed by a 10-minute break. This process is repeated every 2 hours for a total of 6 times (from 8:00 AM to 6:00 PM). |
| The cold spray | Active comparator | Device: Perskindol cold sprayThe cold spray group consists of patients with ankle fractures who receive cold therapy using Perskindol cold spray containing Levomenthol. The spray is applied to the injured ankle 5-6 times, followed by a 10-minute break. This process is repeated every 2 hours for a total of 6 times (from 8:00 AM to 6:00 PM). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Thai male and female individuals
- aged 18 years or older.
- diagnosed by the researcher as having unimalleolar fracture, bimalleolar fracture, or trimalleolar fracture requiring surgery.
- capable of reading and writing in the Thai language.
Key exclusion criteria (9 listed)
- - Fractures in both ankles.
- Pathologic fractures of the ankle bones.
- Simultaneous fractures of the ankle and leg bones.
- Previous history of ankle fractures.
- Nerve-related disorders causing inflammation around the ankle.
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 |
|---|---|---|
| 3M cold packAlso: cold pack3M cold pack | Device | The cold pack group |
| Perskindol cold sprayAlso: cold sprayPerskindol cold spray | Device | The cold spray |
| PlaceboAlso: non-cryotherapy treatmentPlacebo | Device | The control group (non-cryotherapy group) |
Primary outcome
swelling
Time frame: 5 day before surgery
Measuring ankle swelling using the figure-of-eight-20 method, which involves measuring the circumference of the ankle and foot using a tape measure placed along the sides of the foot, passing through specific points,3 time and then averaging the measurements obtained in millimeters.
1 secondary outcome
pain score
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Individual participant dataSharing planned: No
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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?
A study testing 3M cold pack and Perskindol cold spray in people with Ankle Fractures and Swelling, run by Thai Traditional Medical Knowledge Fund at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. 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 5 Mar 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 Thailand. 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. Some participants in this study may receive a placebo. 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?
swelling (time frame: 5 day before surgery). 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 5 Mar 2024.