Effects of Cryotherapy on Knee Function

Sponsor
São Paulo State University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05331079
Collaborator
(none)
80
2
1.1

Study Details

Study Description

Brief Summary

The knee joint is commonly used and also stricken by high loads and injuries in sports. One technique in emphasis is cryotherapy, a physiotherapeutical intervention characterized by the use of low temperatures for tissue trauma's rehabilitation. Several studies analysed the effects of cryotherapy and brought important results related to pain and strength reduction, also to muscle contraction speed reduction. Although, considering the risk-benefit from de intervention it's pertinent to observe the presence of deleterious effects, especially the ones that impact on motor function. This scenario has been brought by scientists and currently the main gap from this theme resides on the repercussions of the technique application on functional answers

Condition or Disease Intervention/Treatment Phase
  • Other: Cryotherapy
N/A

Detailed Description

Eighty participants will receive control (rest) and the experimental condition (cryotherapy), with an interval of 48 hours. The intervention group will undergo: i) assessment, ii) 20 minutes of cryotherapy, iii) reassessment, iv) 20 minutes of rest and v) reassessment, while the control group remains at rest for 20 minutes. Assessments will be composed of knee function by the modified Star Excursion Balance Test, muscle tone by the myoton pro, skin temperature by a thermographic camera, thermic comfort, perception of balance and beliefs in cryotherapy. Data will be described using mean and standard deviation and compared by Mixed ANOVA (time x intervention) with post Bonferroni tests, with significance level of 0.05.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Cryotherapy on Knee Function: Randomized Clinical Trial
Anticipated Study Start Date :
Apr 25, 2022
Anticipated Primary Completion Date :
May 30, 2022
Anticipated Study Completion Date :
May 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cryotherapy

20 minutes of cryotherapy on the dominant knee with ice bags

Other: Cryotherapy
20 minutes of cryotherapy on the dominant knee with ice bags

No Intervention: Control

20 minutes of rest

Outcome Measures

Primary Outcome Measures

  1. Knee balance [Change from baseline to 20 minutes]

    The modified Star Excursion Balance test will measure lower limb reach distance in centimeters

  2. Knee balance [Change from baseline to 40 minutes]

    The modified Star Excursion Balance test will measure lower limb reach distance in centimeters

Secondary Outcome Measures

  1. Skin temperature [Change from baseline to 20 minutes]

    thermographic camera FLIR E-8 XT (FLIR Systems, Sweden)

  2. Skin temperature [Change from baseline to 25 minutes]

    thermographic camera FLIR E-8 XT (FLIR Systems, Sweden)

  3. Skin temperature [Change from baseline to 30 minutes]

    thermographic camera FLIR E-8 XT (FLIR Systems, Sweden)

  4. Skin temperature [Change from baseline to 35 minutes]

    thermographic camera FLIR E-8 XT (FLIR Systems, Sweden)

  5. Skin temperature [Change from baseline to 40 minutes]

    thermographic camera FLIR E-8 XT (FLIR Systems, Sweden)

  6. Thermic Comfort [Change from baseline to 20 minutes]

    a 10cm scale ranging from 0 "very comfortable" and 10 "very uncomfortable" will be used

  7. Thermic Comfort [Change from baseline to 40 minutes]

    a 10cm scale ranging from 0 "very comfortable" and 10 "very uncomfortable" will be used

  8. Balance perception [Change from baseline to 20 minutes]

    a likert scale will be used to answer the question " How good was your balance over the test?" 1=nothing, 2=a little, 3=moderate, 4= a lot, 5=extremely

  9. Balance perception [Change from baseline to 40 minutes]

    a likert scale will be used to answer the question " How good was your balance over the test?" 1=nothing, 2=a little, 3=moderate, 4= a lot, 5=extremely

  10. Muscle tone [Change from baseline to 20 minutes]

    Muscle tone will be measured in hertz by the MyotonPRO wich has a probe that will be placed perpendicular to the skin surface on the muscle belly previously marked with a pen by the evaluator at the Quadriceps;

  11. Muscle tone [Change from baseline to 25 minutes]

    Muscle tone will be measured in hertz by the MyotonPRO wich has a probe that will be placed perpendicular to the skin surface on the muscle belly previously marked with a pen by the evaluator at the Quadriceps;

  12. Muscle tone [Change from baseline to 30 minutes]

    Muscle tone will be measured in hertz by the MyotonPRO wich has a probe that will be placed perpendicular to the skin surface on the muscle belly previously marked with a pen by the evaluator at the Quadriceps;

  13. Muscle tone [Change from baseline to 35 minutes]

    Muscle tone will be measured in hertz by the MyotonPRO wich has a probe that will be placed perpendicular to the skin surface on the muscle belly previously marked with a pen by the evaluator at the Quadriceps;

  14. Muscle tone [Change from baseline to 40 minutes]

    Muscle tone will be measured in hertz by the MyotonPRO wich has a probe that will be placed perpendicular to the skin surface on the muscle belly previously marked with a pen by the evaluator at the Quadriceps;

  15. Beliefs [Baseline]

    The participants will respond yes or no to the questions "Do you believe that cryotherapy is an effect treatment for acute injuries?" and "Do you believe cryotherapy have deleterious effects on muscle function?"

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 28 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 18 to 28 years old

  • healthy

  • no musculoskeletal complaints

Exclusion Criteria:
  • failure to follow protocol

  • complaints of injury or pain during the assessments

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • São Paulo State University

Investigators

  • Study Director: Carlos M Pastre, PhD, Sao Paulo State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Flávia Carvalho, Principal investigator, São Paulo State University
ClinicalTrials.gov Identifier:
NCT05331079
Other Study ID Numbers:
  • EC002
First Posted:
Apr 15, 2022
Last Update Posted:
Apr 15, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Flávia Carvalho, Principal investigator, São Paulo State University

Study Results

No Results Posted as of Apr 15, 2022