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Amylo-Shiatsu-Acute-Chronic: Effects of Shiatsu on Symptoms and Quality of Life of Amyloidosis Patients

RecruitingNAAges 18 Years - anyAllAssistance Publique - Hôpitaux de Paris
NCT06197165 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The objective of this study is to assess the beneficial effects of three targeted Shiatsu sessions compared to "comfort" Shiatsu on symptoms in patients with severe cardiac amyloidosis. Specifically, the study aims to evaluate the short-term impact of a targeted Shiatsu session on neuro-cardiovascular physiological parameters and symptoms in patients with cardiac amyloidosis, in comparison to comfort Shiatsu and no Shiatsu. Additionally, the study will investigate the effects of three targeted Shiatsu sessions versus "comfort" Shiatsu and no Shiatsu on various symptoms (fatigue, sleep disturbances, pain, anxiety, depression, dyspnea, digestive disorders, nausea) and quality of life in cardiac amyloidosis patients with severe symptoms. Patient satisfaction with Shiatsu will also be evaluated, alongside an assessment of the tolerance to Shiatsu.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 18 years ; * Patient with : * Transthyretin of genetic origin (TTR) ; * Transthyretin of non-mutated origin (WT) ; * Light Chain (AL); * Membership of a social security scheme, beneficiary or beneficiary's beneficiary (excluding AME); * Written patient consent. * Score greater than or equal to 3 on the EESE-R questionnaire (Edmonton Symptom Evaluation Scale-Revised), for at least 1 symptom among: dyspnea, digestive disorders, nausea, pain, anxiety, depression (Shiatsu and non-Shiatsu groups); * Score global à l'EESE-R supérieur ou égal à 10 (groupes Shiatsu et sans shiatsu). Exclusion Criteria: * Patients with orthostatic hypotension; * Patients with bullous amyloidosis (fragile skin); * Patients who have already received Shiatsu treatment; * Patient with insufficient autonomy to maintain sitting position; * Patient with insufficient autonomy to move from home to hospital; * Participating in another interventional study, or within the exclusion period of a previous study, if applicable; * Known pregnancy or breast-feeding; * Patient under known guardianship at the time of inclusion; * Patient under AME.
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What it tests

  • Targeted Shiatsu
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Where

1 site
Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
Créteil, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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