Analysis of the Effects on Human Tissues After Application of Therapeutic Modalities.
Condition: Humans; Young Adults; Health
Study type: Interventional

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.
    

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).
    

Intervention name(s): Exclusively ice pack; Ice pack added 10% of water; Ice pack added 100% of water
Intervention type(s): Other; Other; Other
Intervention description(s): 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.; 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.; 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.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A randomized single blind, crossover experimental study.
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Cryotherapy; Skin temperature; Physical therapy modalities; Physical therapy; Thermography; Pain measurement