Effect of Two Methods for the Application of Cryotherapy

Effect of Two Methods for the Application of Cryotherapy in Pain and Surface Temperature of the Skin in Women With Previous Pain in the Knee

Introduction: Little is known about the effects of different cryotherapy techniques for pain and skin surface temperature in patients with anterior knee pain. Objective: To analyze the best technique of cryotherapy intervention to reduce the superficial temperature of the skin and pain of women with anterior pain in the knee. Methodology: The sample will be composed of 12 participants, of the female gender, aged between 18 and 25 years old and complaint of anterior pain in the knee, distributed in cryotherapy groups by ice pack (CPG) (n = 6) and cryotherapy + compression group byGame Ready (CCGR) (n = 6). All will complete the consent form, the sample characterization form, the Visual Analog Pain Scale (EVA) and the Patellofemoral Disorders Scale (AKPS). They will then have the basal temperature of the anterior knee region recorded by thermographic camera and perform five repetitions of the sit and stand test in 30 seconds. The EVA will again respond and the temperature of the anterior knee region will be collected after the test. Subsequently, CPG or CCGR (randomly) will be applied to the anterior region of the knee for 20 minutes. Immediately after the application of cryotherapy, EVA will be applied and will have the skin surface temperature recorded immediately after, and at 10, 20, 30 and 60 minutes. Expected results: It is expected to establish if there is difference in pain, surface temperature and skin reheating of women submitted to cryotherapy by ice pack and Game Ready.

Study Overview

• Status: Unknown
• Conditions: Pain
• Intervention / Treatment: Other: Game Ready; Other: Ice pack

Detailed Description

After the contact, explanation of the study procedures and acceptance of the participants, the data collection will be started and performed in the teaching laboratory of the Physiotherapy course of the State University of Londrina.

Initially, the demographic data of the sample (age, height, weight, limb and time of pain) and signature of the consent term will be collected.

After this step, the participants should point to the Visual Analogue Scale (EVA) and the Patellofemoral Disorders Scale (AKPS). Before performing the cryotherapy technique, the basal skin temperature in the anterior region of the knee will be recorded by means of a thermographic camera, and the participants will be submitted to five sets of the sit and stand test in 30 ', with rest of one minute between them. They will then re-signal the EVA and the skin temperature will be retained by the camera. Finally, they will undergo the application of cryotherapy according to the category which has been "randomized".

The two different intervention techniques will be:

• Ice pack group (CPG): where the participant will have a plastic bag containing 500 grams of crushed ice over the anterior region of the knee, and lie flat with the lower limb extended and supported on the ground for 20 minutes;
• Group Cryotherapy + Compression by Game Ready® (CCGR): where the participant will have the knee joint wrapped and compressed by the equipment where temperature, compression and time will be controlled, maximum compression, for 20 minutes by the equipment itself; lie in the same manner as for the other intervention.

Immediately thereafter, the EVA will be applied and the skin surface temperature recorded in the knee region, as well as 10, 20, 30 and 60 minutes thereafter.

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fernanda B Pesenti, Ma; Phone Number: +55 43 3371 2490; Email: fernanda_pesenti@hotmail.com
• Study Contact Backup: Name: Christiane G Macedo, PhD; Phone Number: +55 43 3371 2490; Email: chmacedouel@yahoo.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• women
• anterior knee pain

Exclusion Criteria:

• muscle or joint injuries in the last month
• vascular problems
• allergy to cold
• lower limb surgery in the last 6 months
• viral conditions (such as colds or flu)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Game Ready group; the participants performed cryotherapy by compression with Game Ready	Other: Game Ready; the participants remained for 20 minutes with intermittent compression therapy + cryotherapy
Experimental: Ice pack; the participants performed cryotherapy for ice pack	Other: Ice pack; the participants remained for 20 minutes with cryotherapy with ice pack

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	measurement pain by analogue visual scale (Score zero to ten, when zero is painless and 10 is maximum pain)	preheating
Pain	measurement pain by analogue visual scale (Score zero to ten, when zero is painless and 10 is maximum pain)	pre-intervention
Pain	measurement pain by analogue visual scale (Score zero to ten, when zero is painless and 10 is maximum pain)	immediately post-intervention
Pain	measurement pain by analogue visual scale (Score zero to ten, when zero is painless and 10 is maximum pain)	up to 60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Temperture	through thermographic camera	preheating
Temperture	through thermographic camera	pre-intervention
Temperture	through thermographic camera	immediately post-intervention
Temperture	through thermographic camera	after 10 minutes
Temperture	through thermographic camera	after 20 minutes
Temperture	through thermographic camera	after 30 minutes
Temperature	through thermographic camera	after 60 minutes

Collaborators and Investigators

• Sponsor: Universidade Estadual de Londrina
• Investigators: Principal Investigator: Christiane G Macedo, PhD, State University of Londrina

Publications and helpful links

General Publications

• Bleakley C, McDonough S, Gardner E, Baxter GD, Hopkins JT, Davison GW. Cold-water immersion (cryotherapy) for preventing and treating muscle soreness after exercise. Cochrane Database Syst Rev. 2012 Feb 15;2012(2):CD008262. doi: 10.1002/14651858.CD008262.pub2.
• Bailey DM, Erith SJ, Griffin PJ, Dowson A, Brewer DS, Gant N, Williams C. Influence of cold-water immersion on indices of muscle damage following prolonged intermittent shuttle running. J Sports Sci. 2007 Sep;25(11):1163-70. doi: 10.1080/02640410600982659.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 20, 2018
• Primary Completion (Anticipated): April 20, 2019
• Study Completion (Anticipated): September 20, 2019

Study Registration Dates

• First Submitted: July 23, 2018
• First Submitted That Met QC Criteria: October 15, 2018
• First Posted (Actual): October 16, 2018

Study Record Updates

• Last Update Posted (Actual): October 16, 2018
• Last Update Submitted That Met QC Criteria: October 15, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: pain; cryotherapy; knee
• Other Study ID Numbers: Knee Cryotherapy Technique

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