CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 16 enrolled
Drug / intervention
Exclusively ice pack +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03414346
NCT03414346N/ACompleted

Comparisons of Differents Percentages of Water Effectiveness During Cryotherapy Application in Reducing Superficial Skin Temperature: A Randomized Single-blind Clinical Trial.

Alessandro Haupenthal·interventional·Posted Jan 29, 2018·Updated Feb 26, 2019

In Brief

A clinical study evaluating Exclusively ice pack, Ice pack added 10% of water, and 1 other intervention for Humans and 2 related conditions. Completed, enrolled 16 participants across 1 site.

Detailed Summary

As a therapeutic modality, cryotherapy is highly used for soft tissue damage control during acute and subacute stages. Cryotherapy is able to reduce pain, inflammatory condition, muscle spasm, nerve conduction, metabolic rate, edema formation and to prevent secondary hypoxic injury. These effects are due to the heat conduction, passing from tissue to different cryotherapy modalities, leading to tissue temperature reduction. The diversity of cryotherapy modalities in clinical practice, like crushed-ice packs, frozen food, gel packs and wetted ice packs, are widely explored by studies. To achieve anesthesia by cryotherapy it's settled that the skin temperature must reach 13,6 degrees celsius (ºC). Ice packs are the most effective modality of cryotherapy when placed directly on the skin, this effectiveness is accentuated when ice packs are associated with water. To improve the contact area the pack must be wrapped. Even though wetted ice packs are the most effective modality, there are few studies approaching it. There aren't studies analyzing an ideal percentage of water to ice in this modality either. Also, it isn't observed if the amount of water interferes on the conduction of the heat from the skin to the ice pack, and in rewarming time. Besides neither of the studies measures the amount of pain during cryotherapy application, and if there was any difference between wetted ice packs, and ice packs isolated. Therefore, the purpose of this study is to analyze the most effective cryotherapy modality for reducing skin temperature, rewarming time, and the amount of discomfort during the application.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJan 29, 2018
Enrollment StartMay 11, 2017
Primary CompletionJun 30, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 8.4 years ago

Interventions

Exclusively ice packother

Each subject will receive an experimental intervention of exclusively 500 grams of crushed ice. The intervention will last 20 minutes, and the order of application, expressed in % of water X ice, will be according to the randomization (realized in the first day). The pack will be wrapped in a band for improvement of the contac area. The subject will be asked to mark his pain level on the visual analogue scale (no pain score of 0 and pain as bad as it could be score of 10) every minute until the total time of the intervention.

Ice pack added 10% of waterother

Each subject will receive an experimental intervention of ice pack added to 50 mL of water. The intervention will last 20 minutes, and the order of application, expressed in % of water X ice, will be according to the randomization (realized in the first day). The pack will be wrapped in a band for improvement of the contac area. The subject will be asked to mark his pain level on the visual analogue scale (no pain score of 0 and pain as bad as it could be score of 10) every minute until the total time of the intervention.

Ice pack added 100% of waterother

Each subject will receive an experimental intervention of ice pack added to 500 mL of water. The intervention will last 20 minutes, and the order of application, expressed in % of water X ice, will be according to the randomization (realized in the first day). The pack will be wrapped in a band for improvement of the contac area. The subject will be asked to mark his pain level on the visual analogue scale (no pain score of 0 and pain as bad as it could be score of 10) every minute until the total time of the intervention.