Amylo-Shiatsu-Acute-Chronic: Effects of Shiatsu on Symptoms and Quality of Life of Amyloidosis Patients
RecruitingNot applicableNCT06197165
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Amylo-Shiatsu-Acute-Chronic: Effects of Shiatsu on Symptoms and Quality of Life of Amyloidosis Patients
- Conditions
- Cardiac Amyloidosis
- Interventions
- Other: Targeted Shiatsu
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Start date
- 2024-03-12
- Primary completion
- 2026-04-12
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- France
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06197165