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Effect of Two Methods for the Application of Cryotherapy

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ClinicalTrials.gov Identifier: NCT03707327
Recruitment Status : Unknown
Verified July 2018 by Universidade Estadual de Londrina.
Recruitment status was:  Not yet recruiting
First Posted : October 16, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Universidade Estadual de Londrina

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.

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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

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




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



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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03707327


Contacts
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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
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Principal Investigator: Christiane G Macedo, PhD State University of Londrina
Publications:
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Responsible Party: Universidade Estadual de Londrina
ClinicalTrials.gov Identifier: NCT03707327    
Other Study ID Numbers: Knee Cryotherapy Technique
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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