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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Minimum dorsal-hand skin temperature during rewarming (IV-X), by infrared thermography
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •Thyroid or other endocrine dysfunction
- •Significant spinal pain
- •Generalised neurological or rheumatological disorders
- •Regular use of pain medications or psychotropic medications
研究组 & 干预措施
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.
干预措施: Ice Pack (Localized Cryotherapy) (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.
干预措施: Thermoneutral Water Pack (Control) (Other)
结局指标
主要结局
Minimum dorsal-hand skin temperature during rewarming (IV-X), by infrared thermography
时间窗: 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.
次要结局
- 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).)
- Pain Intensity (Visual Analogue Scale; VAS) during cooling and immediately after ice-pack removal(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).)