PainNCT03707327
Effect of Two Methods for the Application of Cryotherapy
A study testing Game Ready and Ice pack in people with Pain, run by Universidade Estadual de Londrina.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Game Ready and Ice pack
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2018to 20 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women
- anterior knee pain
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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
- Being tested
- Game Ready, Ice pack
- Keywords
- pain, knee, cryotherapy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Game ReadyOther
the participants remained for 20 minutes with intermittent compression therapy + cryotherapy
Ice packOther
the participants remained for 20 minutes with cryotherapy with ice pack
| Study group | Role | What they receive |
|---|---|---|
| Game Ready group | Experimental | the participants performed cryotherapy by compression with Game Ready Receives: Other: Game Ready |
| Ice pack | Experimental | the participants performed cryotherapy for ice pack Receives: Other: Ice pack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
measurement pain by analogue visual scale (Score zero to ten, when zero is painless and 10 is maximum pain)
Measured: preheating
Pain
measurement pain by analogue visual scale (Score zero to ten, when zero is painless and 10 is maximum pain)
Measured: pre-intervention
Pain
measurement pain by analogue visual scale (Score zero to ten, when zero is painless and 10 is maximum pain)
Measured: immediately post-intervention
Pain
measurement pain by analogue visual scale (Score zero to ten, when zero is painless and 10 is maximum pain)
Measured: up to 60 minutes
Secondary outcomes (7)
Temperture
through thermographic camera
Measured: preheating
Temperture
through thermographic camera
Measured: pre-intervention
Temperture
through thermographic camera
Measured: immediately post-intervention
Temperture
through thermographic camera
Measured: after 10 minutes
Temperture
through thermographic camera
Measured: after 20 minutes
Temperture
through thermographic camera
Measured: after 30 minutes
Temperature
through thermographic camera
Measured: after 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start20 Oct 2018 (estimated)
- Primary completion20 Apr 2019 (estimated)
- Study completion20 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual de Londrina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christiane G Macedo, PhD, Principal investigator, State University of Londrina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03707327
- Sponsor's protocol ID
- Knee Cryotherapy Technique
- Status last verified
- Jul 2018
- First submitted
- 23 Jul 2018
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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. doi: 10.1080/02640410600982659.
PubMed 17654228Bleakley 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.
PubMed 22336838
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03707327
- Acronym / sponsor ID
- Knee Cryotherapy Technique
- Conditions
- Pain
- Keywords
- pain, knee, cryotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Universidade Estadual de LondrinaUniversity, hospital or other
- Study start
- 20 Oct 2018 (estimated)
- Primary completion
- 20 Apr 2019 (estimated)
- Study completion
- 20 Sep 2019 (estimated)
- First posted
- 16 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Game Ready group | Experimental | Other: Game Readythe participants performed cryotherapy by compression with Game Ready |
| Ice pack | Experimental | Other: Ice packthe participants performed cryotherapy for ice pack |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- women
- anterior knee pain
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Game Readythe participants remained for 20 minutes with intermittent compression therapy + cryotherapy | Other | Game Ready group |
| Ice packthe participants remained for 20 minutes with cryotherapy with ice pack | Other | Ice pack |
Primary outcome
Pain
Time frame: preheating
measurement pain by analogue visual scale (Score zero to ten, when zero is painless and 10 is maximum pain)
Pain
Time frame: pre-intervention
measurement pain by analogue visual scale (Score zero to ten, when zero is painless and 10 is maximum pain)
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)
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)
7 secondary outcomes
Temperture
Time frame: preheating
Temperture
Time frame: pre-intervention
Temperture
Time frame: immediately post-intervention
Temperture
Time frame: after 10 minutes
Temperture
Time frame: after 20 minutes
Temperture
Time frame: after 30 minutes
Temperature
Time frame: after 60 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Background: PubMed 17654228Bailey 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.
- Background: PubMed 22336838Bleakley 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christiane G Macedo, PhD principal investigator
State University of Londrina
Questions about this trial
What is this clinical trial studying?
A study testing Game Ready and Ice pack in people with Pain, run by Universidade Estadual de Londrina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernanda B Pesenti, Ma (+55 43 3371 2490, fernanda_pesenti@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: preheating). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03707327, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2018.