Amylo-Shiatsu-Acute-Chronic: Effects of Shiatsu on Symptoms and Quality of Life of Amyloidosis Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 108
- Locations
- 1
- Primary Endpoint
- EESE-R (ESAS) TOTAL SYMPTOM SCORE AT 48 HOURS AFTER THIRD SHIATSU SESSION
Study Overview
Brief Summary
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.
Detailed Description
IAmyloidosis leads to a wide range of disorders, including vascular, cardiac, neuropathic, digestive, renal, and others. These impairments significantly affect patients' quality of life, autonomy, and are often accompanied by stress and anxiety. Literature reviews indicate that complementary approaches have a positive impact on alleviating the symptoms of disabling chronic illnesses, with Shiatsu showing efficacy in several international studies. As part of an initiative to improve patient care and better address their chronic, persistent symptoms, we propose incorporating Shiatsu targeted specifically at amyloidosis symptoms as a complementary therapy. How can Shiatsu help patients with amyloidosis? What impact does it have on their quality of life and various symptoms?
Hypothesis/Objective:
This study aims to demonstrate the beneficial impact of three targeted Shiatsu sessions compared to "comfort" Shiatsu on symptoms in cardiac amyloidosis patients with severe symptoms. Additionally, it will assess the short-term effects of a targeted Shiatsu session on neuro-cardiovascular physiological parameters and symptoms in cardiac amyloidosis patients, comparing the effects of targeted Shiatsu, comfort Shiatsu, and no Shiatsu. The study will evaluate the impact of these interventions on symptoms such as fatigue, sleep disturbances, pain, anxiety, depression, dyspnea, digestive disorders, and nausea, as well as the overall quality of life. It will also assess patient satisfaction with Shiatsu and evaluate the therapy's tolerance.
Method:
This is a randomized, controlled, superiority, single-center, double-blind study comparing the effects of "targeted" Shiatsu sessions on amyloidosis symptoms with those of "comfort" (non-targeted) Shiatsu sessions.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Shiatsu
Comfort Shiatsu: 39
Targeted Shiatsu: 39
Intervention: Targeted Shiatsu (Other)
without Shiatsu
patients with cardiac amyloidosis with severe symptoms
Intervention: Targeted Shiatsu (Other)
Outcomes
Primary Outcomes
EESE-R (ESAS) TOTAL SYMPTOM SCORE AT 48 HOURS AFTER THIRD SHIATSU SESSION
Time Frame: 31 days ± 1 day
Description of efficacy endpoints for primary endpoint: Reduction in total ESAS symptom score at 48 hours after third shiatsu session. Questionnaire at J0 (before first session) - J2 (48 H after first session)- J16 48H (after third session) - J31 48H (15 days after third session).
Secondary Outcomes
- MEASUREMENT PHYSIO, SUDOSCAN, E-PATCH(48 hours)