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

NCT03414346 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-02-26

No results posted yet for this study

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.

Conditions

  • Humans
  • Young Adults
  • Health

Interventions

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.

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.

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.

Sponsors & Collaborators

  • Santa Catarina Federal University

    collaborator OTHER
  • Alessandro Haupenthal

    lead OTHER

Principal Investigators

  • Alessandro Haupenthal, Doctorate · Santa Catarina Federal University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-11
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03414346 on ClinicalTrials.gov