Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06293209 |
| Other study ID # |
Sunpasitthiprasong Hospital |
| Secondary ID |
Sunpasitthipraso |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2023 |
| Est. completion date |
May 28, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Thai Traditional Medical Knowledge Fund |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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
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.
