Hand Cooling With Ice Packs in Healthy Young Men

NCT07254182 | Completed

• 1 other identifier: AWF-Poznan-HandIce-RCT-001
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cold Exposure; Body Temperature Regulation; Thermal Comfort Perception

Keywords

Skin Temperature; Infrared Thermography (IRT); Thermal Sensation; Local Cooling

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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)

  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)

  Baseline (after acclimatisation; time point I) and 0 minutes after ice-pack removal (time point IV).

• Thermal Sensation (TSS) during cooling and immediately post

  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

  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).

Study Arms (2)

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.

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.

Other: Thermoneutral Water Pack (Control)

Interventions

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

Ice Pack (Localized Cryotherapy)

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.

Thermoneutral Water Pack (Control)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• Diabetes
• Thyroid or other endocrine dysfunction
• Significant spinal pain
• Generalised neurological or rheumatological disorders
• Regular use of pain medications or psychotropic medications

Sponsors & Collaborators

• Poznan University of Physical Education: lead

Study Sites (1)

Poznan University of Physical Education, Department of Physical Therapy and Sports Recovery

Poznan, 61-871, Poland

Location

Study Officials

• Anna Straburzyńska-Lupa, MD, PhD

  Department of Physical Therapy and Sports Recovery, Faculty of Health Sciences, Poznan University of Physical Education, 61-871 Poznań, Poland;

  STUDY CHAIR

• Pawel P Korman, PhD

  Department of Physical Therapy and Sports Recovery, Faculty of Health Sciences, Poznan University of Physical Education, 61-871 Poznań, Poland;

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding of outcomes assessors only. Thermographic image analysis and statistical analyses were performed by personnel not involved in data collection and blinded to group assignment; data were labeled by study ID without treatment identifiers. Participants and intervention administrators were unblinded due to perceptible cooling
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 28, 2025
• Study Start: April 12, 2018
• Primary Completion: July 11, 2018
• Study Completion: July 11, 2018
• Last Updated: November 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: From the date of article publication (or trial results posting) for 5 years.
• Access Criteria: De-identified IPD (IRT skin temperature, RTD, thermal sensation/comfort, pain VAS, MDT, VDT, age \[years\], sex \[male\]) plus codebook available to qualified academic/non-profit researchers for non-commercial use. Request via email to \[PI; pkorman@awf.poznan.pl\] with a brief proposal and ethics approval; reviewed by the PI, response within 30 days. Access requires a Data Use Agreement (no re-ID, secure storage, no third-party sharing, use only as approved, cite the primary article/Zenodo, destroy/return within 5 years). Data provided as CSV via secure link after DUA; available from publication/results posting for up to 5 years; no fee.

Locations

PL (1)