HumansNCT03414346
Analysis of the Effects on Human Tissues After Application of Therapeutic Modalities.
A study testing Exclusively ice pack, Ice pack added 10% of water and Ice pack added 100% of water in people with Humans and Young Adults, run by Alessandro Haupenthal at 1 site in Brazil.
Trial summary
As a therapeutic modality, cryotherapy is highly used for soft tissue damage control during acute and subacute stages. Cryotherapy is able to reduce pain, inflammatory condition, muscle spasm, nerve conduction, metabolic rate, edema formation and to prevent secondary hypoxic injury. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Humans, Young Adults, Health
- What is being tested?
- Exclusively ice pack, Ice pack added 10% of water and Ice pack added 100% of water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteBrazil
- Study dates
- 11 May 2017to 30 Jun 2018
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- No orthopedic injury in three months prior to the study;
- A minimum of 18 years of age, and a maximum of 40 years;
- Female;
- Must agree not to practice exercise the day before the study and not ingest caffeine, alcohol, or foods one hour before intervention.
Who cannot join
- Cold hypersensitivity and urticaria;
- Cold hyposensitivity;
- Raynaud's phenomenon diagnosed;
- Any thigh open wound;
- Muscular or neurological disease;
- Diabetes diagnosed;
- Cigarette smokers.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Santa Catarina Federal University
Araranguá, Santa Catarina, 88.906-072
About this study
Official title: Comparisons of Differents Percentages of Water Effectiveness During Cryotherapy Application in Reducing Superficial Skin Temperature: A Randomized Single-blind Clinical Trial.
As a therapeutic modality, cryotherapy is highly used for soft tissue damage control during acute and subacute stages. Cryotherapy is able to reduce pain, inflammatory condition, muscle spasm, nerve conduction, metabolic rate, edema formation and to prevent secondary hypoxic injury. These effects are due to the heat conduction, passing from tissue to different cryotherapy modalities, leading to tissue temperature reduction.
The diversity of cryotherapy modalities in clinical practice, like crushed-ice packs, frozen food, gel packs and wetted ice packs, are widely explored by studies. To achieve anesthesia by cryotherapy it's settled that the skin temperature must reach 13,6 degrees celsius (ºC). Ice packs are the most effective modality of cryotherapy when placed directly on the skin, this effectiveness is accentuated when ice packs are associated with water. To improve the contact area the pack must be wrapped.
Read more
Even though wetted ice packs are the most effective modality, there are few studies approaching it. There aren't studies analyzing an ideal percentage of water to ice in this modality either. Also, it isn't observed if the amount of water interferes on the conduction of the heat from the skin to the ice pack, and in rewarming time. Besides neither of the studies measures the amount of pain during cryotherapy application, and if there was any difference between wetted ice packs, and ice packs isolated.
Therefore, the purpose of this study is to analyze the most effective cryotherapy modality for reducing skin temperature, rewarming time, and the amount of discomfort during the application.
Read the detailed description
The data for the sample size calculation was taken from Kanlayanaphotpron and Janwantanakul (2005), that also approached the cryotherapy application. The software used to calculate the sample was GPower 3.1.9.2. A 16 subjects sample were obtained to reach a power of 90%, needed to detect a difference on the average of the groups in repeated measures with an alpha of 5%. The subjects will be chosen through social media and informal invitations.
The subjects will attend to the laboratory four times, the first day for orientation and measurements (body mass and skinfold), and the data collection will start on the second day.
The room temperature will be set between 23 ° C and 25 ° C, and the humidity around 70%. The subject will be in supine position on the stretcher, relaxed and instructed not to touch the right thigh region for 20 minutes before the intervention to stabilize the body temperature. The thigh will be measured and the center marked to determine the place where the pack will settle and the temperature collected.
The intervention will last 20 minutes, and the order of application will be according to the randomization. The subject will be asked to mark his pain level on the visual analogue scale every minute.
The temperature of the right thigh will be measured by infrared thermography, before the intervention, right after the removal and every minute until the total time of the intervention.
To summarize the data, it will be used descriptive statistics, the values of average, standard deviation and the collected measurements will be identified. Through Shapiro-Wilk test the distribution of data regarding normality will be verified. To compare the initial and the final test values the ANOVA and the post-hoc of Bonferroni will be used. In the case of data being out of the normal standards, a transformation will be used to reach the normality. If the data still don't reach the normality after the transformation, the non-parametric tests will be used (Mann-Whitney e Kruskal Walis). The confidence level adopted for all tests will be 95% (p <0.05).
- Conditions
- Humans, Young Adults, Health
- Being tested
- Exclusively ice pack, Ice pack added 10% of water, Ice pack added 100% of water
- Keywords
- Cryotherapy, Skin temperature, Physical therapy modalities, Physical therapy, Thermography, Pain measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exclusively ice packOther
Each subject will receive an experimental intervention of exclusively 500 grams of crushed ice. The intervention will last 20 minutes, and the order of application, expressed in % of water X ice, will be according to the randomization (realized in the first day). The pack will be wrapped in a band for improvement of the contac area. The subject will be asked to mark his pain level on the visual analogue scale (no pain score of 0 and pain as bad as it could be score of 10) every minute until the total time of the intervention.
Ice pack added 10% of waterOther
Each subject will receive an experimental intervention of ice pack added to 50 mL of water. The intervention will last 20 minutes, and the order of application, expressed in % of water X ice, will be according to the randomization (realized in the first day). The pack will be wrapped in a band for improvement of the contac area. The subject will be asked to mark his pain level on the visual analogue scale (no pain score of 0 and pain as bad as it could be score of 10) every minute until the total time of the intervention.
Ice pack added 100% of waterOther
Each subject will receive an experimental intervention of ice pack added to 500 mL of water. The intervention will last 20 minutes, and the order of application, expressed in % of water X ice, will be according to the randomization (realized in the first day). The pack will be wrapped in a band for improvement of the contac area. The subject will be asked to mark his pain level on the visual analogue scale (no pain score of 0 and pain as bad as it could be score of 10) every minute until the total time of the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Exclusively ice pack: | Experimental | Ice pack application: 500 grams of crushed ice. Receives: Other: Exclusively ice pack |
| Ice pack added 10% of water: | Experimental | Wetted ice pack application: 500 grams of crushed ice added to 50 mL of water at room temperature. Receives: Other: Ice pack added 10% of water |
| Ice pack added 100% of water: | Experimental | Wetted ice pack application: 500 grams of crushed ice added to 500 mL of water at room temperature. Receives: Other: Ice pack added 100% of water |
What is being measured
The primary outcome is the main question the study is designed to answer.
The most effective cryotherapy modality
Evaluation of the most effective percentage of water and ice, as a cryotherapy modality, in attenuating skin temperature. It will be evaluated in three visits, 24 hours apart each.
Measured: 3 days
Secondary outcomes (2)
Rewarming after ice application.
The skin temperature will be verified before the application of cryotherapy and after during 40 minutes, 2 minutes apart each measure.
Measured: 3 days
Recurrence of pain.
The patient will be instructed to point the amount of pain minute by minute from time 0 to 20 minutes of application.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start11 May 2017
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HumansStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A randomized single blind, crossover experimental study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alessandro Haupenthal
- Sponsor type
- University, hospital or other
- Collaborators
- Santa Catarina Federal University
- Responsible party
- Sponsor-investigator, Alessandro Haupenthal, Universidade Federal de Santa Catarina
- Investigators
- Alessandro Haupenthal, Doctorate, Study director, Santa Catarina Federal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03414346
- Sponsor's protocol ID
- 1771454
- Status last verified
- Feb 2019
- First submitted
- 31 Oct 2017
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Belitsky RB, Odam SJ, Hubley-Kozey C. Evaluation of the effectiveness of wet ice, dry ice, and cryogenic packs in reducing skin temperature. Phys Ther. 1987 Jul;67(7):1080-4. doi: 10.1093/ptj/67.7.1080.
PubMed 3602101Chesterton LS, Foster NE, Ross L. Skin temperature response to cryotherapy. Arch Phys Med Rehabil. 2002 Apr;83(4):543-9. doi: 10.1053/apmr.2002.30926.
PubMed 11932859Dykstra JH, Hill HM, Miller MG, Cheatham CC, Michael TJ, Baker RJ. Comparisons of cubed ice, crushed ice, and wetted ice on intramuscular and surface temperature changes. J Athl Train. 2009 Mar-Apr;44(2):136-41. doi: 10.4085/1062-6050-44.2.136.
PubMed 19295957Enwemeka CS, Allen C, Avila P, Bina J, Konrade J, Munns S. Soft tissue thermodynamics before, during, and after cold pack therapy. Med Sci Sports Exerc. 2002 Jan;34(1):45-50. doi: 10.1097/00005768-200201000-00008.
PubMed 11782646Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343Herrera E, Sandoval MC, Camargo DM, Salvini TF. Effect of walking and resting after three cryotherapy modalities on the recovery of sensory and motor nerve conduction velocity in healthy subjects. Rev Bras Fisioter. 2011 May-Jun;15(3):233-40. doi: 10.1590/s1413-35552011000300010.
PubMed 21829988Jutte LS, Merrick MA, Ingersoll CD, Edwards JE. The relationship between intramuscular temperature, skin temperature, and adipose thickness during cryotherapy and rewarming. Arch Phys Med Rehabil. 2001 Jun;82(6):845-50. doi: 10.1053/apmr.2001.23195.
PubMed 11387593Kanlayanaphotporn R, Janwantanakul P. Comparison of skin surface temperature during the application of various cryotherapy modalities. Arch Phys Med Rehabil. 2005 Jul;86(7):1411-5. doi: 10.1016/j.apmr.2004.11.034.
PubMed 16003673Oosterveld FG, Rasker JJ, Jacobs JW, Overmars HJ. The effect of local heat and cold therapy on the intraarticular and skin surface temperature of the knee. Arthritis Rheum. 1992 Feb;35(2):146-51. doi: 10.1002/art.1780350204.
PubMed 1734903de Estefani D, Ruschel C, Beninca IL, Dos Santos Haupenthal DP, de Avelar NCP, Haupenthal A. Volume of water added to crushed ice affects the efficacy of cryotherapy: a randomised, single-blind, crossover trial. Physiotherapy. 2020 Jun;107:81-87. doi: 10.1016/j.physio.2019.12.005. Epub 2019 Dec 16.
PubMed 32026839
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparisons of Differents Percentages of Water Effectiveness During Cryotherapy Application in Reducing Superficial Skin Temperature: A Randomized Single-blind Clinical Trial.
- ClinicalTrials.gov ID
- NCT03414346
- Acronym / sponsor ID
- 1771454
- Conditions
- Humans, Young Adults, Health
- Keywords
- Cryotherapy, Skin temperature, Physical therapy modalities, Physical therapy, Thermography, Pain measurement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Alessandro HaupenthalUniversity, hospital or other
- Collaborators
- Santa Catarina Federal University
- Study start
- 11 May 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 29 Jan 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.
As a therapeutic modality, cryotherapy is highly used for soft tissue damage control during acute and subacute stages. Cryotherapy is able to reduce pain, inflammatory condition, muscle spasm, nerve conduction, metabolic rate, edema formation and to prevent secondary hypoxic injury. These effects are due to the heat conduction, passing from tissue to different cryotherapy modalities, leading to tissue temperature reduction.
The diversity of cryotherapy modalities in clinical practice, like crushed-ice packs, frozen food, gel packs and wetted ice packs, are widely explored by studies. To achieve anesthesia by cryotherapy it's settled that the skin temperature must reach 13,6 degrees celsius (ºC). Ice packs are the most effective modality of cryotherapy when placed directly on the skin, this effectiveness is accentuated when ice packs are associated with water. To improve the contact area the pack must be wrapped.
Even though wetted ice packs are the most effective modality, there are few studies approaching it. There aren't studies analyzing an ideal percentage of water to ice in this modality either. Also, it isn't observed if the amount of water interferes on the conduction of the heat from the skin to the ice pack, and in rewarming time. Besides neither of the studies measures the amount of pain during cryotherapy application, and if there was any difference between wetted ice packs, and ice packs isolated.
Therefore, the purpose of this study is to analyze the most effective cryotherapy modality for reducing skin temperature, rewarming time, and the amount of discomfort during the application.
Detailed description
The data for the sample size calculation was taken from Kanlayanaphotpron and Janwantanakul (2005), that also approached the cryotherapy application. The software used to calculate the sample was GPower 3.1.9.2. A 16 subjects sample were obtained to reach a power of 90%, needed to detect a difference on the average of the groups in repeated measures with an alpha of 5%. The subjects will be chosen through social media and informal invitations.
The subjects will attend to the laboratory four times, the first day for orientation and measurements (body mass and skinfold), and the data collection will start on the second day.
The room temperature will be set between 23 ° C and 25 ° C, and the humidity around 70%. The subject will be in supine position on the stretcher, relaxed and instructed not to touch the right thigh region for 20 minutes before the intervention to stabilize the body temperature. The thigh will be measured and the center marked to determine the place where the pack will settle and the temperature collected.
The intervention will last 20 minutes, and the order of application will be according to the randomization. The subject will be asked to mark his pain level on the visual analogue scale every minute.
The temperature of the right thigh will be measured by infrared thermography, before the intervention, right after the removal and every minute until the total time of the intervention.
To summarize the data, it will be used descriptive statistics, the values of average, standard deviation and the collected measurements will be identified. Through Shapiro-Wilk test the distribution of data regarding normality will be verified. To compare the initial and the final test values the ANOVA and the post-hoc of Bonferroni will be used. In the case of data being out of the normal standards, a transformation will be used to reach the normality. If the data still don't reach the normality after the transformation, the non-parametric tests will be used (Mann-Whitney e Kruskal Walis). The confidence level adopted for all tests will be 95% (p <0.05).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- A randomized single blind, crossover experimental study.
| Arm | Type | Receives |
|---|---|---|
| Exclusively ice pack: | Experimental | Other: Exclusively ice packIce pack application: 500 grams of crushed ice. |
| Ice pack added 10% of water: | Experimental | Other: Ice pack added 10% of waterWetted ice pack application: 500 grams of crushed ice added to 50 mL of water at room temperature. |
| Ice pack added 100% of water: | Experimental | Other: Ice pack added 100% of waterWetted ice pack application: 500 grams of crushed ice added to 500 mL of water at room temperature. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- No orthopedic injury in three months prior to the study;
- A minimum of 18 years of age, and a maximum of 40 years;
- Female;
- Must agree not to practice exercise the day before the study and not ingest caffeine, alcohol, or foods one hour before intervention.
Key exclusion criteria (7 listed)
- Cold hypersensitivity and urticaria;
- Cold hyposensitivity;
- Raynaud's phenomenon diagnosed;
- Any thigh open wound;
- Muscular or neurological disease;
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 |
|---|---|---|
| Exclusively ice packEach subject will receive an experimental intervention of exclusively 500 grams of crushed ice. The intervention will last 20 minutes, and the order of application, expressed in % of water X ice, will be according to the randomization (realized in the first day). The pack will be wrapped in a band for improvement of the contac area. The subject will be asked to mark his pain level on the visual analogue scale (no pain score of 0 and pain as bad as it could be score of 10) every minute until the total time of the intervention. | Other | Exclusively ice pack: |
| Ice pack added 10% of waterEach subject will receive an experimental intervention of ice pack added to 50 mL of water. The intervention will last 20 minutes, and the order of application, expressed in % of water X ice, will be according to the randomization (realized in the first day). The pack will be wrapped in a band for improvement of the contac area. The subject will be asked to mark his pain level on the visual analogue scale (no pain score of 0 and pain as bad as it could be score of 10) every minute until the total time of the intervention. | Other | Ice pack added 10% of water: |
| Ice pack added 100% of waterEach subject will receive an experimental intervention of ice pack added to 500 mL of water. The intervention will last 20 minutes, and the order of application, expressed in % of water X ice, will be according to the randomization (realized in the first day). The pack will be wrapped in a band for improvement of the contac area. The subject will be asked to mark his pain level on the visual analogue scale (no pain score of 0 and pain as bad as it could be score of 10) every minute until the total time of the intervention. | Other | Ice pack added 100% of water: |
Primary outcome
The most effective cryotherapy modality
Time frame: 3 days
Evaluation of the most effective percentage of water and ice, as a cryotherapy modality, in attenuating skin temperature. It will be evaluated in three visits, 24 hours apart each.
2 secondary outcomes
Rewarming after ice application.
Time frame: 3 days
Recurrence of pain.
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Background: PubMed 3602101Belitsky RB, Odam SJ, Hubley-Kozey C. Evaluation of the effectiveness of wet ice, dry ice, and cryogenic packs in reducing skin temperature. Phys Ther. 1987 Jul;67(7):1080-4. doi: 10.1093/ptj/67.7.1080.
- Background: PubMed 11932859Chesterton LS, Foster NE, Ross L. Skin temperature response to cryotherapy. Arch Phys Med Rehabil. 2002 Apr;83(4):543-9. doi: 10.1053/apmr.2002.30926.
- Background: PubMed 19295957Dykstra JH, Hill HM, Miller MG, Cheatham CC, Michael TJ, Baker RJ. Comparisons of cubed ice, crushed ice, and wetted ice on intramuscular and surface temperature changes. J Athl Train. 2009 Mar-Apr;44(2):136-41. doi: 10.4085/1062-6050-44.2.136.
- Background: PubMed 11782646Enwemeka CS, Allen C, Avila P, Bina J, Konrade J, Munns S. Soft tissue thermodynamics before, during, and after cold pack therapy. Med Sci Sports Exerc. 2002 Jan;34(1):45-50. doi: 10.1097/00005768-200201000-00008.
- Background: PubMed 17695343Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
- Background: PubMed 21829988Herrera E, Sandoval MC, Camargo DM, Salvini TF. Effect of walking and resting after three cryotherapy modalities on the recovery of sensory and motor nerve conduction velocity in healthy subjects. Rev Bras Fisioter. 2011 May-Jun;15(3):233-40. doi: 10.1590/s1413-35552011000300010.
- Background: PubMed 11387593Jutte LS, Merrick MA, Ingersoll CD, Edwards JE. The relationship between intramuscular temperature, skin temperature, and adipose thickness during cryotherapy and rewarming. Arch Phys Med Rehabil. 2001 Jun;82(6):845-50. doi: 10.1053/apmr.2001.23195.
- Background: PubMed 16003673Kanlayanaphotporn R, Janwantanakul P. Comparison of skin surface temperature during the application of various cryotherapy modalities. Arch Phys Med Rehabil. 2005 Jul;86(7):1411-5. doi: 10.1016/j.apmr.2004.11.034.
- Background: PubMed 1734903Oosterveld FG, Rasker JJ, Jacobs JW, Overmars HJ. The effect of local heat and cold therapy on the intraarticular and skin surface temperature of the knee. Arthritis Rheum. 1992 Feb;35(2):146-51. doi: 10.1002/art.1780350204.
- Derived from this study: PubMed 32026839de Estefani D, Ruschel C, Beninca IL, Dos Santos Haupenthal DP, de Avelar NCP, Haupenthal A. Volume of water added to crushed ice affects the efficacy of cryotherapy: a randomised, single-blind, crossover trial. Physiotherapy. 2020 Jun;107:81-87. doi: 10.1016/j.physio.2019.12.005. Epub 2019 Dec 16.
- 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.
Alessandro Haupenthal, Doctorate study director
Santa Catarina Federal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exclusively ice pack, Ice pack added 10% of water and Ice pack added 100% of water in people with Humans and Young Adults, run by Alessandro Haupenthal at 1 site in Brazil.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The most effective cryotherapy modality (time frame: 3 days). 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 NCT03414346, which also lists 10 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 26 Feb 2019.