Effect of Two Methods for the Application of Cryotherapy

NCT ID: NCT03707327

Last Updated: 2018-10-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-20
• Study Completion Date: 2019-09-20

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.

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Game Ready group

the participants performed cryotherapy by compression with Game Ready

Group Type: EXPERIMENTAL

Game Ready

Intervention Type: OTHER

the participants remained for 20 minutes with intermittent compression therapy + cryotherapy

Ice pack

the participants performed cryotherapy for ice pack

Group Type: EXPERIMENTAL

Ice pack

Intervention Type: OTHER

the participants remained for 20 minutes with cryotherapy with ice pack

Interventions

Game Ready

the participants remained for 20 minutes with intermittent compression therapy + cryotherapy

Intervention Type: OTHER

Ice pack

the participants remained for 20 minutes with cryotherapy with ice pack

Intervention Type: OTHER

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Estadual de Londrina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christiane G Macedo, PhD

Role: PRINCIPAL_INVESTIGATOR

State University of Londrina

Central Contacts

Fernanda B Pesenti, Ma

Role: CONTACT

fernanda_pesenti@hotmail.com

+55 43 3371 2490

Christiane G Macedo, PhD

Role: CONTACT

chmacedouel@yahoo.com.br

+55 43 3371 2490

References

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.

Reference Type: BACKGROUND

PMID: 17654228 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22336838 (View on PubMed)

Other Identifiers

Knee Cryotherapy Technique

Identifier Type: -

Identifier Source: org_study_id