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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Dec 26, 2023

Keywords

ClinConnect Summary

This clinical trial, titled "Amylo-Shiatsu-Acute-Chronic," is exploring how Shiatsu massage can help patients with severe cardiac amyloidosis, a condition where abnormal proteins build up in the heart and affect its function. The study will compare the effects of three targeted Shiatsu sessions, which focus on specific symptoms, to "comfort" Shiatsu, which is more relaxing but not specifically targeted. Researchers want to see if these sessions can improve symptoms like fatigue, pain, anxiety, and sleep issues, as well as enhance patients' overall quality of life.

To participate in this trial, you must be at least 18 years old and have a specific type of amyloidosis, such as transthyretin or light chain amyloidosis. Eligible participants should experience significant symptoms that can be measured using a questionnaire. If you join, you can expect to receive Shiatsu treatments over a short period, and your comfort and satisfaction with the sessions will be monitored. It's important to note that certain individuals, such as those with fragile skin or who have previously received Shiatsu, won't be able to participate. This study aims to provide valuable insights into how Shiatsu may benefit those struggling with this challenging condition.

Gender

ALL

Eligibility criteria

• 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.