Effects of Cryotherapy on Knee Function

Effects of Cryotherapy on Knee Function: Randomized Clinical Trial

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

Study Overview

• Status: Not yet recruiting
• Conditions: Functional Status; Muscle Tone
• Intervention / Treatment: Other: Cryotherapy

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Flavia A Carvalho, MSc; Phone Number: +5518997443624; Email: fla.acarvalho@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 28 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee balance	The modified Star Excursion Balance test will measure lower limb reach distance in centimeters	Change from baseline to 20 minutes
Knee balance	The modified Star Excursion Balance test will measure lower limb reach distance in centimeters	Change from baseline to 40 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin temperature	thermographic camera FLIR E-8 XT (FLIR Systems, Sweden)	Change from baseline to 20 minutes
Skin temperature	thermographic camera FLIR E-8 XT (FLIR Systems, Sweden)	Change from baseline to 25 minutes
Skin temperature	thermographic camera FLIR E-8 XT (FLIR Systems, Sweden)	Change from baseline to 30 minutes
Skin temperature	thermographic camera FLIR E-8 XT (FLIR Systems, Sweden)	Change from baseline to 35 minutes
Skin temperature	thermographic camera FLIR E-8 XT (FLIR Systems, Sweden)	Change from baseline to 40 minutes
Thermic Comfort	a 10cm scale ranging from 0 "very comfortable" and 10 "very uncomfortable" will be used	Change from baseline to 20 minutes
Thermic Comfort	a 10cm scale ranging from 0 "very comfortable" and 10 "very uncomfortable" will be used	Change from baseline to 40 minutes
Balance perception	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	Change from baseline to 20 minutes
Balance perception	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	Change from baseline to 40 minutes
Muscle tone	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;	Change from baseline to 20 minutes
Muscle tone	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;	Change from baseline to 25 minutes
Muscle tone	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;	Change from baseline to 30 minutes
Muscle tone	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;	Change from baseline to 35 minutes
Muscle tone	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;	Change from baseline to 40 minutes
Beliefs	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?"	Baseline

Collaborators and Investigators

• Sponsor: São Paulo State University
• Investigators: Study Director: Carlos M Pastre, PhD, São Paulo State University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 25, 2022
• Primary Completion (Anticipated): May 30, 2022
• Study Completion (Anticipated): May 30, 2022

Study Registration Dates

• First Submitted: April 8, 2022
• First Submitted That Met QC Criteria: April 8, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Actual): April 15, 2022
• Last Update Submitted That Met QC Criteria: April 8, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Balance; Knee; Cryotherapy
• Other Study ID Numbers: EC002

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
• product manufactured in and exported from the U.S.: No