Effect of Two Methods for the Application of Cryotherapy

• ClinicalTrials.gov Identifier: NCT03707327
• Recruitment Status: Unknown
• First Posted: October 16, 2018
• Last Update Posted: October 16, 2018
• Sponsor: Universidade Estadual de Londrina
• Information provided by (Responsible Party): Universidade Estadual de Londrina

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Pain	Other: Game Ready; Other: Ice pack	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: 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
• Estimated Study Start Date: October 20, 2018
• Estimated Primary Completion Date: April 20, 2019
• Estimated Study Completion Date: September 20, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Pain [ Time Frame: preheating ]
   measurement pain by analogue visual scale (Score zero to ten, when zero is painless and 10 is maximum pain)
2. Pain [ Time Frame: pre-intervention ]
   measurement pain by analogue visual scale (Score zero to ten, when zero is painless and 10 is maximum pain)
3. Pain [ Time Frame: immediately post-intervention ]
   measurement pain by analogue visual scale (Score zero to ten, when zero is painless and 10 is maximum pain)
4. Pain [ Time Frame: up to 60 minutes ]
   measurement pain by analogue visual scale (Score zero to ten, when zero is painless and 10 is maximum pain)

Secondary Outcome Measures :

1. Temperture [ Time Frame: preheating ]
   through thermographic camera
2. Temperture [ Time Frame: pre-intervention ]
   through thermographic camera
3. Temperture [ Time Frame: immediately post-intervention ]
   through thermographic camera
4. Temperture [ Time Frame: after 10 minutes ]
   through thermographic camera
5. Temperture [ Time Frame: after 20 minutes ]
   through thermographic camera
6. Temperture [ Time Frame: after 30 minutes ]
   through thermographic camera
7. Temperature [ Time Frame: after 60 minutes ]
   through thermographic camera

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 25 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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)

Contacts and Locations

Contacts

Contact: Fernanda B Pesenti, Ma; +55 43 3371 2490; fernanda_pesenti@hotmail.com

Contact: Christiane G Macedo, PhD; +55 43 3371 2490; chmacedouel@yahoo.com.br

Sponsors and Collaborators

Universidade Estadual de Londrina

Investigators

• Principal Investigator: Christiane G Macedo, PhD; State University of Londrina

More Information

Publications:

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.

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;(2):CD008262. doi: 10.1002/14651858.CD008262.pub2.

• Responsible Party: Universidade Estadual de Londrina
• ClinicalTrials.gov Identifier: NCT03707327
• Other Study ID Numbers: Knee Cryotherapy Technique
• First Posted: October 16, 2018
• Last Update Posted: October 16, 2018
• Last Verified: July 2018

Individual Participant Data (IPD) Sharing Statement:

• 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 Universidade Estadual de Londrina:

pain; knee; cryotherapy