Analysis of the Effects on Human Tissues After Application of Therapeutic Modalities.

February 25, 2019 updated by: Alessandro Haupenthal

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The data for the sample size calculation was taken from Kanlayanaphotpron and Janwantanakul (2005), that also approached the cryotherapy application. The software used to calculate the sample was GPower 3.1.9.2. A 16 subjects sample were obtained to reach a power of 90%, needed to detect a difference on the average of the groups in repeated measures with an alpha of 5%. The subjects will be chosen through social media and informal invitations.

The subjects will attend to the laboratory four times, the first day for orientation and measurements (body mass and skinfold), and the data collection will start on the second day.

The room temperature will be set between 23 ° C and 25 ° C, and the humidity around 70%. The subject will be in supine position on the stretcher, relaxed and instructed not to touch the right thigh region for 20 minutes before the intervention to stabilize the body temperature. The thigh will be measured and the center marked to determine the place where the pack will settle and the temperature collected.

The intervention will last 20 minutes, and the order of application will be according to the randomization. The subject will be asked to mark his pain level on the visual analogue scale every minute.

The temperature of the right thigh will be measured by infrared thermography, before the intervention, right after the removal and every minute until the total time of the intervention.

To summarize the data, it will be used descriptive statistics, the values of average, standard deviation and the collected measurements will be identified. Through Shapiro-Wilk test the distribution of data regarding normality will be verified. To compare the initial and the final test values the ANOVA and the post-hoc of Bonferroni will be used. In the case of data being out of the normal standards, a transformation will be used to reach the normality. If the data still don't reach the normality after the transformation, the non-parametric tests will be used (Mann-Whitney e Kruskal Walis). The confidence level adopted for all tests will be 95% (p <0.05).

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SC
      • Araranguá, SC, Brazil, 88.906-072
        • Santa Catarina Federal University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • No orthopedic injury in three months prior to the study;
  • A minimum of 18 years of age, and a maximum of 40 years;
  • Female;
  • Must agree not to practice exercise the day before the study and not ingest caffeine, alcohol, or foods one hour before intervention.

Exclusion Criteria:

  • Cold hypersensitivity and urticaria;
  • Cold hyposensitivity;
  • Raynaud's phenomenon diagnosed;
  • Any thigh open wound;
  • Muscular or neurological disease;
  • Diabetes diagnosed;
  • Cigarette smokers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exclusively ice pack:
Ice pack application: 500 grams of crushed ice.
Other: Exclusively ice pack
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.
Experimental: Ice pack added 10% of water:
Wetted ice pack application: 500 grams of crushed ice added to 50 mL of water at room temperature.
Other: Ice pack added 10% of water
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.
Experimental: Ice pack added 100% of water:
Wetted ice pack application: 500 grams of crushed ice added to 500 mL of water at room temperature.
Other: Ice pack added 100% of water
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The most effective cryotherapy modality
Time Frame: 3 days
Evaluation of the most effective percentage of water and ice, as a cryotherapy modality, in attenuating skin temperature. It will be evaluated in three visits, 24 hours apart each.
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rewarming after ice application.
Time Frame: 3 days
The skin temperature will be verified before the application of cryotherapy and after during 40 minutes, 2 minutes apart each measure.
3 days
Recurrence of pain.
Time Frame: 3 days
The patient will be instructed to point the amount of pain minute by minute from time 0 to 20 minutes of application.
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alessandro Haupenthal

Collaborators

Santa Catarina Federal University

Investigators

  • Study Director: Alessandro Haupenthal, Doctorate, Santa Catarina Federal University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2017

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

October 31, 2017

First Submitted That Met QC Criteria

January 22, 2018

First Posted (Actual)

January 29, 2018

Study Record Updates

Last Update Posted (Actual)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 25, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1771454

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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