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足部反射疗法对帕金森病慢性疼痛的影响:一项随机对照试验。

Effect of foot reflexology on chronic pain in Parkinson's disease: A randomized controlled trial.

作者信息

Joineau Karel, Harroch Estelle, Boussac Mathilde, Fabbri Margherita, Leung Clémence, Ory-Magne Fabienne, Rousseau Vanessa, Peran Patrice, Brefel-Courbon Christine, Descamps Emeline

机构信息

Toulouse NeuroImaging Center (ToNIC - UMR1214 INSERM/Toulouse University III), Toulouse, France.

Department of Clinical Pharmacology and Neurology, University Hospital of Toulouse, Toulouse, France.

出版信息

PLoS One. 2025 Jul 28;20(7):e0327865. doi: 10.1371/journal.pone.0327865. eCollection 2025.

Abstract

OBJECTIVES

Effectiveness of Foot Reflexology (FR) on the pain intensity in Parkinson's disease (PD) compared with Sham Massage (SM).

DESIGN

Monocentric, longitudinal, prospective, double-blind, randomized controlled trial. Randomization with a random number generator in the R software. Fixed-sized block randomization of 3 implemented into Clinsight.

PARTICIPANTS

Idiopathic PD patients with chronic pain (Visual Analogue Scale (VAS)≥4) were recruited from the Toulouse University Hospital between the 14th of April 2021 and the 25th of May 2025.

INTERVENTION

Four one-hour long FR or SM sessions three weeks apart with the same specialized FR researcher.

MAIN OUTCOME MEASURE

Pain intensity change measured by the mean VAS before and after full completed interventions. The difference was compared between group using a Wilcoxon Mann Witney test. Exploratory outcome: brain functional connectivity.

RESULTS

30 PD patients were randomized and analyzed. Interventions were delivered as planned for all patients. Clinical variables did not significantly differed between FR and SM groups. Mean VAS decreased by -12.3 mm ± 15.2 in FR group (n = 15) and -17.9 mm ± 29.4 in SM group (n = 15). Analyses did not reveal any significant difference between the FR and SM groups (p-value = 0.88). There are different patterns in connectivity changes in the medial pain system between responders (at least 30% pain reduction) and non-responders to both therapies. There were no adverse events.

CONCLUSION

FR is not more effective than SM in relieving chronic pain in PD. The differences in connectivity patterns within the medial pain pathway may underlie the response to tactile stimulation (FR and SM).

TRIAL REGISTRATION

ClinicalTrials.gov NCT04705207.

摘要

目的

与假按摩(SM)相比,足部反射疗法(FR)对帕金森病(PD)疼痛强度的影响。

设计

单中心、纵向、前瞻性、双盲、随机对照试验。使用R软件中的随机数生成器进行随机分组。在Clinsight中实施固定大小为3的区组随机化。

参与者

2021年4月14日至2025年5月25日期间从图卢兹大学医院招募患有慢性疼痛(视觉模拟评分(VAS)≥4)的特发性PD患者。

干预措施

由同一位专业的FR研究人员进行,每三周进行一次,每次时长一小时,共进行四次FR或SM治疗。

主要观察指标

在完整干预前后,通过平均VAS测量疼痛强度变化。使用Wilcoxon Mann Witney检验比较两组之间的差异。探索性结果:脑功能连接性。

结果

30例PD患者被随机分组并进行分析。所有患者均按计划接受干预。FR组和SM组的临床变量无显著差异。FR组(n = 15)的平均VAS下降了-12.3 mm±15.2,SM组(n = 15)下降了-17.9 mm±29.4。分析未发现FR组和SM组之间有任何显著差异(p值 = 0.88)。在对两种疗法有反应者(疼痛减轻至少30%)和无反应者之间,内侧疼痛系统的连接性变化模式不同。未发生不良事件。

结论

在缓解PD慢性疼痛方面,FR并不比SM更有效。内侧疼痛通路内连接模式的差异可能是对触觉刺激(FR和SM)产生反应的基础。

试验注册

ClinicalTrials.gov NCT04705207。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/da88/12303304/e416afa07ed1/pone.0327865.g001.jpg

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