NCT03707327

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Oct 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 16, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

October 20, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2019

Completed
Last Updated

October 16, 2018

Status Verified

July 1, 2018

Enrollment Period

6 months

First QC Date

July 23, 2018

Last Update Submit

October 15, 2018

Conditions

Pain

Keywords

painkneecryotherapy

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (7)

  • Temperture

    preheating

  • Temperture

    pre-intervention

  • Temperture

    immediately post-intervention

  • Temperture

    after 10 minutes

  • Temperture

    after 20 minutes

  • +2 more secondary outcomes

Study Arms (2)

Game Ready group

EXPERIMENTAL

the participants performed cryotherapy by compression with Game Ready

Other: Game Ready

Ice pack

EXPERIMENTAL

the participants performed cryotherapy for ice pack

Other: Ice pack

Interventions

Game ReadyOTHER

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

Game Ready group
Ice packOTHER

the participants remained for 20 minutes with cryotherapy with ice pack

Ice pack

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • women
  • anterior knee pain

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 17654228BACKGROUND

  • 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.

    PMID: 22336838BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christiane G Macedo, PhD

    State University of Londrina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernanda B Pesenti, Ma

CONTACT

+55 43 3371 2490fernanda_pesenti@hotmail.com

Christiane G Macedo, PhD

CONTACT

+55 43 3371 2490chmacedouel@yahoo.com.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2018

First Posted

October 16, 2018

Study Start

October 20, 2018

Primary Completion

April 20, 2019

Study Completion

September 20, 2019

Last Updated

October 16, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share