Cold ExposureICEHANDNCT07254182
Hand Cooling With Ice Packs in Healthy Young Men
A study testing Ice Pack (Localized Cryotherapy) in people with Cold Exposure and Body Temperature Regulation, run by Poznan University of Physical Education at 1 site in Poland.
Trial summary
This randomized, parallel-group study looked at how a standard 15-minute ice pack applied to the back of the hand affects skin temperature and how cold and comfortable the hand feels, compared with a room-temperature water pack. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cold Exposure, Body Temperature Regulation, Thermal Comfort Perception
- What is being tested?
- Ice Pack (Localized Cryotherapy)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 sitePoland
- Study dates
- 12 Apr 2018to 11 Jul 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 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers (university student population).
- Good general health with no history of neck or upper-quadrant pain.
- Able to provide written informed consent.
- Willing to comply with pre-visit restrictions on the study day (abstain from tobacco, coffee, alcohol; no hand ointments for 24 h; wash/degrease hands ≥1 h before testing; refrain from vigorous exercise/physical treatments for 24 h).
Who cannot join
- Diabetes
- Thyroid or other endocrine dysfunction
- Significant spinal pain
- Generalised neurological or rheumatological disorders
- Regular use of pain medications or psychotropic medications
Trial locations and contacts
1 site in 1 country.
Poland1 site
Poznan University of Physical Education, Department of Physical Therapy and Sports Recovery
Poznan, 61-871
About this study
Official title: Effects of Ice-Pack Application on Hand Skin Temperature and Subjective Thermal Sensation and Comfort in Healthy Young Men: A Randomized, Parallel-Group Controlled Trial
This randomized, parallel-group study looked at how a standard 15-minute ice pack applied to the back of the hand affects skin temperature and how cold and comfortable the hand feels, compared with a room-temperature water pack. Healthy young men were randomly assigned to one of the two groups during a single laboratory visit. Skin temperature was measured before, during, and after the application, and participants rated their thermal sensation (how cold/warm they felt) and overall comfort.
The main outcome was the change in hand skin temperature right after the 15-minute application. Additional outcomes included comfort and cold-feeling ratings and how quickly skin temperature returned toward baseline during recovery. This was a minimal-risk study; expected short-term effects included temporary cold, numbness, redness, or mild discomfort. No medicines or invasive procedures were used.
- Being tested
- Ice Pack (Localized Cryotherapy), Thermoneutral Water Pack (Control)
- Keywords
- Skin Temperature, Infrared Thermography (IRT), Thermal Sensation, Local Cooling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ice Pack (Localized Cryotherapy)Other
Single 15-minute application of a reusable plastic Mueller ice bag (Ø 22.86 cm, 946 mL). The bag was filled with 400 g pre-portioned cylindrical ice and placed on the dorsal side of the dominant hand, ~1 cm proximal to the wrist-joint line, fully covering the fingers. Participants were supine with the treated hand slightly elevated; ambient temperature and humidity were controlled (≈22.5 ± 1.0 °C; 55.3 ± 6.5% RH). Subjective thermal sensation/comfort (and pain) were recorded at minutes 7 and 15 during application. Arm: Experimental - Ice Pack
Thermoneutral Water Pack (Control)Other
Identical 15-minute application using the same Mueller bag, filled with thermoneutral water (within ±0.5 °C of limb skin temperature), mass-matched to 400 g. Placement, posture, room conditions, and timing of subjective assessments (minutes 7 and 15) mirrored the experimental arm: bag on the dorsal side of the dominant hand, ~1 cm proximal to the wrist-joint line, fully covering the fingers; participants supine with the hand slightly elevated. Arm: Active Comparator - Thermoneutral Water Pack.
| Study group | Role | What they receive |
|---|---|---|
| Ice Pack (Localized Cryotherapy) | Experimental | Single 15-minute application of a reusable plastic ice pack (Mueller; Ø 22.86 cm, 946 mL). The pack was filled with 400 g of pre-portioned cylindrical ice and placed on the dorsal side of the dominant hand, ~1 cm proximal to the wrist-joint line, fully covering the fingers. Participants were supine with the hand slightly elevated; ambient conditions were controlled at ≈22.5 ± 1.0 °C and 55.3 ± 6.5% relative humidity (RH).Contact was maintained throughout the application; thermal sensation/comfort and pain were recorded during the 7th and 15th minutes. Receives: Other: Ice Pack (Localized Cryotherapy) |
| Thermoneutral Water Pack (Control) | Active comparator | Identical 15-minute application using the same Mueller pack filled with thermoneutral water (within ±0.5 °C of limb skin temperature), mass-matched to 400 g. Placement, posture, and ambient conditions mirrored the experimental arm: pack on the dorsal side of the dominant hand, ~1 cm proximal to the wrist-joint line, fully covering the fingers; participants supine, hand slightly elevated; sensation/comfort and pain recorded at minutes 7 and 15. Receives: Other: Thermoneutral Water Pack (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum dorsal-hand skin temperature during rewarming (IV-X), by infrared thermography
Region-of-interest (ROI) mean skin temperature (Tsk; °C) on the dorsal hand measured with infrared thermography (IRT; FLIR SC640). The primary estimand is the between-group mean difference (Ice - Thermoneutral) in the nadir (minimum) across rewarming time points IV-X, with 95% confidence intervals (CI). Lower values indicate greater cooling.
Measured: From immediately after pack removal (0 minutes; time point IV) to 30 minutes after pack removal (time point X).
Secondary outcomes (6)
IRT-RT temperature offset at matched time points I-X
Difference between infrared-thermography-derived skin temperature (TskIRT) and resistance temperature detector-derived skin temperature (TskRT), in degrees Celsius (°C), at each matched time point (I-X). IRT values represent ROI averages; resistance temperature (RT) values are point skin temperature readings from a RTD placed between the 3rd and 4th metacarpal bones. Positive values indicate that TskIRT is greater than TskRT. Between-group comparisons across time.
Measured: Baseline (after acclimatisation) and at 0, 5, 10, 15, 20, 25, and 30 minutes after ice-pack removal.
Change in Mechanical Detection Threshold (MDT) from baseline to immediately post (I → IV)
MDT (g) via Semmes-Weinstein monofilaments using an up-down procedure; analysed as IV - I. Higher values indicate reduced tactile sensitivity.
Measured: Baseline (after acclimatisation; time point I) and 0 minutes after ice-pack removal (time point IV).
Change in Vibration Detection Threshold (VDT) from baseline to immediately post (I → IV)
VDT using a 64-Hz Rydel-Seiffer tuning fork (0-8/8 scale); analysed as IV - I. Higher values indicate reduced vibration sensitivity.
Measured: Baseline (after acclimatisation; time point I) and 0 minutes after ice-pack removal (time point IV).
Thermal Sensation (TSS) during cooling and immediately post
9-point TSS (-4 very cold … +4 very hot) at I-IV; peak during cooling prespecified as the maximum at II or III. Between-group comparison of peak and trajectory.
Measured: Baseline (after acclimatisation; time point I), 7 minutes after ice-pack application (time point II), 15 minutes after ice-pack application (time point III), and 0 minutes after ice-pack removal (time point IV).
Thermal Comfort (CS) during cooling and immediately post
5-point comfort scale (1 comfortable … 5 extremely uncomfortable) at I-IV; peak during cooling prespecified as the maximum at II or III.
Measured: Baseline (after acclimatisation; time point I), 7 minutes after ice-pack application (time point II), 15 minutes after ice-pack application (time point III), and 0 minutes after ice-pack removal (time point IV).
Pain Intensity (Visual Analogue Scale; VAS) during cooling and immediately after ice-pack removal
0-100 mm visual analogue scale; peak during cooling prespecified as the maximum at II or III.
Measured: Baseline (after acclimatisation; time point I), 7 minutes after ice-pack application (time point II), 15 minutes after ice-pack application (time point III), and 0 minutes after ice-pack removal (time point IV).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start12 Apr 2018
- Primary completion11 Jul 2018
- Study completion11 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cold ExposureStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Straburzyńska-Lupa, MD, PhD, Study chair, Department of Physical Therapy and Sports Recovery, Faculty of Health Sciences, Poznan University of Physical Education, 61-871 Poznań, Poland;Pawel P Korman, PhD, Principal investigator, Department of Physical Therapy and Sports Recovery, Faculty of Health Sciences, Poznan University of Physical Education, 61-871 Poznań, Poland;
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254182
- Sponsor's protocol ID
- AWF-Poznan-HandIce-RCT-001
- Acronym
- ICEHAND
- Status last verified
- Oct 2025
- First submitted
- 14 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be available upon reasonable request for non-commercial research. Available IPD will include dorsal-hand skin temperature (IRT ROI means and RTD readings across time points I-X), thermal sensation, thermal comfort, pain VAS, MDT and VDT results, plus a data dictionary. Requests should be sent to \[kontakt e-mail\]. Proposals will be reviewed by the Principal Investigator; access requires a data use agreement and confirmation of ethics approval/waiver. Supporting materials (study protocol and SAP) and de-identified summary datasets are archived at Zenodo (DOI: 10.5281/zenodo.17255092).
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ice-Pack Application on Hand Skin Temperature and Subjective Thermal Sensation and Comfort in Healthy Young Men: A Randomized, Parallel-Group Controlled Trial
- ClinicalTrials.gov ID
- NCT07254182
- Acronym / sponsor ID
- ICEHAND / AWF-Poznan-HandIce-RCT-001
- Keywords
- Skin Temperature, Infrared Thermography (IRT), Thermal Sensation, Local Cooling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Study start
- 12 Apr 2018 (actual)
- Primary completion
- 11 Jul 2018 (actual)
- Study completion
- 11 Jul 2018 (actual)
- First posted
- 28 Nov 2025 (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.
This randomized, parallel-group study looked at how a standard 15-minute ice pack applied to the back of the hand affects skin temperature and how cold and comfortable the hand feels, compared with a room-temperature water pack. Healthy young men were randomly assigned to one of the two groups during a single laboratory visit. Skin temperature was measured before, during, and after the application, and participants rated their thermal sensation (how cold/warm they felt) and overall comfort.
The main outcome was the change in hand skin temperature right after the 15-minute application. Additional outcomes included comfort and cold-feeling ratings and how quickly skin temperature returned toward baseline during recovery. This was a minimal-risk study; expected short-term effects included temporary cold, numbness, redness, or mild discomfort. No medicines or invasive procedures were used.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ice Pack (Localized Cryotherapy) | Experimental | Other: Ice Pack (Localized Cryotherapy)Single 15-minute application of a reusable plastic ice pack (Mueller; Ø 22.86 cm, 946 mL). The pack was filled with 400 g of pre-portioned cylindrical ice and placed on the dorsal side of the dominant hand, ~1 cm proximal to the wrist-joint line, fully covering the fingers. Participants were supine with the hand slightly elevated; ambient conditions were controlled at ≈22.5 ± 1.0 °C and 55.3 ± 6.5% relative humidity (RH).Contact was maintained throughout the application; thermal sensation/comfort and pain were recorded during the 7th and 15th minutes. |
| Thermoneutral Water Pack (Control) | Active comparator | Other: Thermoneutral Water Pack (Control)Identical 15-minute application using the same Mueller pack filled with thermoneutral water (within ±0.5 °C of limb skin temperature), mass-matched to 400 g. Placement, posture, and ambient conditions mirrored the experimental arm: pack on the dorsal side of the dominant hand, ~1 cm proximal to the wrist-joint line, fully covering the fingers; participants supine, hand slightly elevated; sensation/comfort and pain recorded at minutes 7 and 15. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male volunteers (university student population).
- Good general health with no history of neck or upper-quadrant pain.
- Able to provide written informed consent.
- Willing to comply with pre-visit restrictions on the study day (abstain from tobacco, coffee, alcohol; no hand ointments for 24 h; wash/degrease hands ≥1 h before testing; refrain from vigorous exercise/physical treatments for 24 h).
Key exclusion criteria (5 listed)
- Diabetes
- Thyroid or other endocrine dysfunction
- Significant spinal pain
- Generalised neurological or rheumatological disorders
- Regular use of pain medications or psychotropic medications
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 |
|---|---|---|
| Ice Pack (Localized Cryotherapy)Single 15-minute application of a reusable plastic Mueller ice bag (Ø 22.86 cm, 946 mL). The bag was filled with 400 g pre-portioned cylindrical ice and placed on the dorsal side of the dominant hand, ~1 cm proximal to the wrist-joint line, fully covering the fingers. Participants were supine with the treated hand slightly elevated; ambient temperature and humidity were controlled (≈22.5 ± 1.0 °C; 55.3 ± 6.5% RH). Subjective thermal sensation/comfort (and pain) were recorded at minutes 7 and 15 during application. Arm: Experimental - Ice Pack | Other | Ice Pack (Localized Cryotherapy) |
| Thermoneutral Water Pack (Control)Identical 15-minute application using the same Mueller bag, filled with thermoneutral water (within ±0.5 °C of limb skin temperature), mass-matched to 400 g. Placement, posture, room conditions, and timing of subjective assessments (minutes 7 and 15) mirrored the experimental arm: bag on the dorsal side of the dominant hand, ~1 cm proximal to the wrist-joint line, fully covering the fingers; participants supine with the hand slightly elevated. Arm: Active Comparator - Thermoneutral Water Pack. | Other | Thermoneutral Water Pack (Control) |
Primary outcome
Minimum dorsal-hand skin temperature during rewarming (IV-X), by infrared thermography
Time frame: From immediately after pack removal (0 minutes; time point IV) to 30 minutes after pack removal (time point X).
Region-of-interest (ROI) mean skin temperature (Tsk; °C) on the dorsal hand measured with infrared thermography (IRT; FLIR SC640). The primary estimand is the between-group mean difference (Ice - Thermoneutral) in the nadir (minimum) across rewarming time points IV-X, with 95% confidence intervals (CI). Lower values indicate greater cooling.
6 secondary outcomes
IRT-RT temperature offset at matched time points I-X
Time frame: Baseline (after acclimatisation) and at 0, 5, 10, 15, 20, 25, and 30 minutes after ice-pack removal.
Change in Mechanical Detection Threshold (MDT) from baseline to immediately post (I → IV)
Time frame: Baseline (after acclimatisation; time point I) and 0 minutes after ice-pack removal (time point IV).
Change in Vibration Detection Threshold (VDT) from baseline to immediately post (I → IV)
Time frame: Baseline (after acclimatisation; time point I) and 0 minutes after ice-pack removal (time point IV).
Thermal Sensation (TSS) during cooling and immediately post
Time frame: Baseline (after acclimatisation; time point I), 7 minutes after ice-pack application (time point II), 15 minutes after ice-pack application (time point III), and 0 minutes after ice-pack removal (time point IV).
Thermal Comfort (CS) during cooling and immediately post
Time frame: Baseline (after acclimatisation; time point I), 7 minutes after ice-pack application (time point II), 15 minutes after ice-pack application (time point III), and 0 minutes after ice-pack removal (time point IV).
Pain Intensity (Visual Analogue Scale; VAS) during cooling and immediately after ice-pack removal
Time frame: Baseline (after acclimatisation; time point I), 7 minutes after ice-pack application (time point II), 15 minutes after ice-pack application (time point III), and 0 minutes after ice-pack removal (time point IV).
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 28 Nov 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be available upon reasonable request for non-commercial research. Available IPD will include dorsal-hand skin temperature (IRT ROI means and RTD readings across time points I-X), thermal sensation, thermal comfort, pain VAS, MDT and VDT results, plus a data dictionary. Requests should be sent to [kontakt e-mail]. Proposals will be reviewed by the Principal Investigator; access requires a data use agreement and confirmation of ethics approval/waiver. Supporting materials (study protocol and SAP) and de-identified summary datasets are archived at Zenodo (DOI: 10.5281/zenodo.17255092).
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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.
Anna Straburzyńska-Lupa, MD, PhD study chair
Department of Physical Therapy and Sports Recovery, Faculty of Health Sciences, Poznan University of Physical Education, 61-871 Poznań, Poland;
Pawel P Korman, PhD principal investigator
Department of Physical Therapy and Sports Recovery, Faculty of Health Sciences, Poznan University of Physical Education, 61-871 Poznań, Poland;
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ice Pack (Localized Cryotherapy) in people with Cold Exposure and Body Temperature Regulation, run by Poznan University of Physical Education at 1 site in Poland.
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 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: finished, as of the sponsor's last update on 28 Nov 2025. 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 Poland. 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?
Minimum dorsal-hand skin temperature during rewarming (IV-X), by infrared thermography (time frame: From immediately after pack removal (0 minutes; time point IV) to 30 minutes after pack removal (time point X).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Nov 2025.