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一项随机、对照、患者自身对照、单盲的试点研究,旨在评估成人烧伤幸存者接受12周透皮疗法的疗效。

Randomized, controlled, within-patient, single-blinded pilot study to evaluate the efficacy of 12-weeks of endermotherapy with adult burn survivors.

作者信息

Nedelec Bernadette, Edger-Lacoursière Zoë, Gauthier Nathalie, Marois-Pagé Elisabeth, Jean Stéphanie

机构信息

School of Physical and Occupational Therapy, McGill University, Montreal, Quebec, Canada; Hôpital de réadaptation Villa Medica, Montreal, Quebec, Canada; Centre de recherche, Centre hospitalier de l'Université de Montréal (CRCHUM), Montreal, Quebec, Canada.

School of Physical and Occupational Therapy, McGill University, Montreal, Quebec, Canada; Hôpital de réadaptation Villa Medica, Montreal, Quebec, Canada.

出版信息

Burns. 2024 Dec;50(9):107269. doi: 10.1016/j.burns.2024.09.008. Epub 2024 Sep 22.

DOI:10.1016/j.burns.2024.09.008
PMID:39343632
Abstract

BACKGROUND

Vacuum massage, or endermotherapy, is applied to scar tissue with the primary therapeutic goal of promoting structural or physiological changes. These changes are intended to enhance pliability, enabling the skin to possess the strength and elasticity required for normal mobility. The advantage of vacuum massage compared to therapist-generated manual massage is that it provides a standardized dosage using rollers and suction valves to mobilize the tissue. However, research documenting and supporting its impact on post-burn hypertrophic scar is lacking. Thus, this study was designed to objectively characterize the changes in scar elasticity, erythema, melanin, thickness, and transepidermal water loss immediately after a vacuum massage session and after a 12-week course of treatment compared to intra-individual matched control scars.

METHODS

We conducted a prospective, randomized, controlled, within-patient, single-blinded clinical trial, initially designed as a fully-powered study but limited to a pilot study due to COVID-19 restrictions. Nineteen burn survivors consented to participate and 16 completed the study. Two homogeneous, intra-individual scars were randomized to usual care control or vacuum massage therapy plus usual care. Vacuum massage interventions were provided by a certified massage therapist three times per week for 12 weeks. Scar characteristics were evaluated every four weeks immediately before and after mechanical massage treatment. The evaluations included measurements of elasticity (Cutometer), erythema and melanin (Mexameter), transepidermal water loss (TEWL) (Tewameter), and thickness (high-frequency ultrasound). Linear mixed-model analyses were performed to test for immediate and long-term treatment effects.

RESULTS

The ANOVA analyses revealed a non-significant time:treatment interaction for elasticity, erythema, melanin, thickness, or TEWL. There was a significant increase in elasticity and erythema and a decrease in TEWL in both the control and treatment sites over time with consistent standard care. However, there was no statistically significant immediate or long-term treatment effect for any of the skin characteristics. Nonetheless, the mean participant satisfaction was 4/5 (SD = 1.5) and the mean participant perception of effectiveness was 8/10 (SD = 1.9).

CONCLUSIONS

This pilot study did not find a treatment benefit of vacuum massage therapy for elasticity, erythema, melanin, thickness or TEWL, but it did find an improvement with time in elasticity, erythema and TEWL. Despite the lack of objective improvement of the treated scar site, participants were satisfied with the results and believed vacuum massage was very effective. Further high-quality research is required to better inform clinicians patient education and treatment decisions for this costly, burdensome treatment approach that has high participant satisfaction.

摘要

背景

真空按摩,即皮下组织按摩疗法,应用于瘢痕组织,其主要治疗目标是促进结构或生理变化。这些变化旨在增强柔韧性,使皮肤具备正常活动所需的强度和弹性。与治疗师进行的手动按摩相比,真空按摩的优势在于它使用滚轮和吸气阀来移动组织,从而提供标准化剂量。然而,缺乏记录和支持其对烧伤后增生性瘢痕影响的研究。因此,本研究旨在客观描述与个体内匹配的对照瘢痕相比,在一次真空按摩疗程后以及经过12周治疗疗程后,瘢痕弹性、红斑、黑色素、厚度和经表皮水分流失的变化。

方法

我们进行了一项前瞻性、随机、对照、患者内单盲临床试验,最初设计为一项充分有力的研究,但由于新冠疫情限制而限于一项试点研究。19名烧伤幸存者同意参与,16名完成了研究。将两个同质的个体内瘢痕随机分为常规护理对照组或真空按摩疗法加常规护理组。由一名认证按摩治疗师每周进行3次真空按摩干预,持续12周。在机械按摩治疗前后每四周评估瘢痕特征。评估包括弹性(皮肤弹性测定仪)、红斑和黑色素(皮肤颜色测定仪)、经表皮水分流失(TEWL)(皮肤水分流失测定仪)和厚度(高频超声)的测量。进行线性混合模型分析以测试即时和长期治疗效果。

结果

方差分析显示,在弹性、红斑、黑色素、厚度或TEWL方面,时间与治疗的交互作用不显著。随着持续的标准护理,对照组和治疗组的弹性和红斑均显著增加,TEWL均降低。然而,对于任何皮肤特征,均未发现有统计学意义的即时或长期治疗效果。尽管如此,参与者的平均满意度为4/5(标准差 = 1.5),参与者对有效性的平均感知为八分(标准差 = 1.9)。

结论

这项试点研究未发现真空按摩疗法对弹性、红斑、黑色素、厚度或TEWL有治疗益处,但确实发现随着时间推移,弹性、红斑和TEWL有所改善。尽管治疗的瘢痕部位缺乏客观改善,但参与者对结果感到满意,并认为真空按摩非常有效。需要进一步的高质量研究,以便为临床医生在这种成本高昂、负担沉重但参与者满意度高的治疗方法的患者教育和治疗决策方面提供更好的信息。

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