Actively Recruiting
Amylo-Shiatsu-Acute-Chronic: Effects of Shiatsu on Symptoms and Quality of Life of Amyloidosis Patients
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-01-15
108
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of targeted Shiatsu therapy on symptoms and quality of life in patients with severe cardiac amyloidosis. It compares three targeted Shiatsu sessions with "comfort" Shiatsu and no Shiatsu, focusing on short-term impacts on neuro-cardiovascular physiological parameters and symptoms such as fatigue, sleep issues, pain, anxiety, depression, breathing difficulties, digestive problems, and nausea. The study also assesses patient satisfaction and tolerance to Shiatsu treatment. The trial is a randomized, controlled, double-blind study conducted at a single center, involving 108 patients with different types of amyloidosis (TTR, WT, AL). Participants are assigned to receive either targeted Shiatsu, comfort Shiatsu, or no Shiatsu. The study schedule includes an initial visit with questionnaires and physiological measurements, followed by Shiatsu sessions on days 7 and 14 for the Shiatsu groups, with multiple follow-up visits and telephone contacts to monitor symptoms and quality of life. Participants will complete various symptom and quality of life questionnaires and undergo physiological tests such as skin conductance (SUDOSCAN) and heart rate variability monitoring (e-patch). Follow-up assessments occur at several timepoints up to one month after the third Shiatsu session. The primary outcome is the reduction in symptom scores 48 hours after the third Shiatsu session. Secondary outcomes include improvements in physiological measures and specific symptom scales. Safety and patient satisfaction are also evaluated throughout the study.
CONDITIONS
Brief Title
Amylo-Shiatsu-Acute-Chronic: Effects of Shiatsu on Symptoms and Quality of Life of Amyloidosis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with transthyretin (genetic or non-mutated) or light chain (AL) amyloidosis
- Member or beneficiary of a social security scheme (excluding AME)
- Provided written consent to participate
- Score of 3 or higher on the EESE-R questionnaire for at least one symptom: dyspnea, digestive disorders, nausea, pain, anxiety, or depression
- Overall EESE-R score of 10 or higher
You will not qualify if you...
- Orthostatic hypotension
- Bullous amyloidosis with fragile skin
- Previous Shiatsu treatment
- Insufficient autonomy to maintain sitting position
- Insufficient autonomy to travel from home to hospital
- Participation in another interventional study, or within exclusion period of a prior study
- Known pregnancy or breastfeeding
- Under legal guardianship at time of inclusion
- Beneficiary of AME (medical aid for foreigners)
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 weeks
Participants receive three Shiatsu sessions targeted or comfort Shiatsu to evaluate effects on amyloidosis symptoms and quality of life.
3 Shiatsu sessions with assessments around each session
Duration - Up to 31 days after first Shiatsu session
Participants complete questionnaires and undergo physiological measurements to assess symptom changes and therapy tolerance after the Shiatsu sessions.
Multiple visits and telephone follow-ups over 31 days
Trial Site Locations
Total: 1 location
1
Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
Créteil, France, 94010
Actively Recruiting
Research Team
J
JULIE POMPOUGNAC, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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