Hand Cooling With Ice Packs in Healthy Young Men

NCT ID: NCT07254182

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-12
• Study Completion Date: 2018-07-11

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ice Pack (Localized Cryotherapy)

Intervention Type: 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)

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.

Group Type: ACTIVE_COMPARATOR

Thermoneutral Water Pack (Control)

Intervention Type: 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.

Interventions

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

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Poznan University of Physical Education

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anna Straburzyńska-Lupa, MD, PhD

Role: 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

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Poznan, , Poland

Countries

Poland

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Study Documents

Document Type: Individual Participant Data Set

View Document

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

AWF-Poznan-HandIce-RCT-001

Identifier Type: -

Identifier Source: org_study_id