Cardiac AmyloidosisAMYLO-SHIATSUNCT06197165
Amylo-Shiatsu-Acute-Chronic: Effects of Shiatsu on Symptoms and Quality of Life of Amyloidosis Patients
A study testing Targeted Shiatsu in people with Cardiac Amyloidosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Amyloidosis
- What is being tested?
- Targeted Shiatsu
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteFrance
- Study dates
- 12 Mar 2024to 12 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
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- 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).
Who cannot join
- 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;
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- Known pregnancy or breast-feeding;
- Patient under known guardianship at the time of inclusion;
- Patient under AME.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
Créteil, 94010
About this study
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.
Read the 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.
Population:
The study will involve patients diagnosed with amyloidosis (TTR, WT, AL) who are hospitalized or followed at the Centre de Référence Amyloses-Cardiaques (Cardiogen branch) at the CHU Henri Mondor in Créteil, France. A total of 108 patients will participate: 78 in the Shiatsu group (26 AL, 26 TTR, 26 WT), 39 in the Comfort Shiatsu group, 39 in the Targeted Shiatsu group, and 30 in the No Shiatsu group. The expected inclusion rate per center per month is 4.5, with a study duration of 2 years.
Primary Endpoint:
Reduction in total ESAS symptom score 48 hours after the third Shiatsu session.
Secondary Endpoints:
A 20% improvement in heart rate variability measured with the e-patch. A 20% improvement in skin conductance and variability measured with the SUDOSCAN.
Overall score on the EQ-5D scale. Overall score on the MINNESOTA scale. A 2-point improvement in the symptom-specific questionnaire corresponding to the symptom targeted by Shiatsu (e.g., dyspnea, digestive disorders, pain).
Improvement in at least one global score on the BFI, HADS, or LSEQ scales.
Inclusion Visit (D0):
Patients will be offered participation during their routine care consultation. Once consent is obtained, the patient will complete several questionnaires (MINNESOTA, EESE-R, EQ-5D, QCD, BFI, LSEQ, HADS). Measurements with the SUDOSCAN will be taken, and the e-patch will be applied for 48 hours. For Shiatsu participants, randomization will be conducted by an open-label CRA independent of the study, and the results will be sent to the Shiatsu specialists (targeted or comfort). The patient will then receive a Shiatsu session accordingly.
Research Follow-Up Visits:
Visit 1 (D1): A second SUDOSCAN measurement will be taken 24 hours post-Shiatsu session or inclusion for the no-Shiatsu group. Follow-up measurements will be taken at 24 and 48 hours.
Visit 2 (D2): A third SUDOSCAN measurement will be taken 48 hours post-Shiatsu or inclusion. Patients will complete the EESE-R and modified TAQ questionnaires.
Visit 3 (D7±1 day): The Shiatsu group will receive a second Shiatsu session and complete the modified TAQ questionnaire 48 hours later (D9±1 day).
Visit 4 (D14±1 day): The Shiatsu group will receive a third Shiatsu session and complete the modified TAQ questionnaire 48 hours after the session (D16±1 day).
Telephone Visits:
Contact 1 (D16±1 day): Telephone follow-up 48 hours after the third Shiatsu session, during which patients will complete various questionnaires (MINNESOTA, EESE-R, EQ-5D, QCD, BFI, LSEQ, HADS, modified TAQ).
Contact 2 (D31±1 day): A second telephone follow-up to complete the same set of questionnaires.
Conclusion:
The expected benefits for patients include an improvement in quality of life and symptoms (e.g., appetite, nausea, digestive disorders, sleep, fatigue, anxiety, depression, pain) as well as balancing of the autonomic nervous system (ANS), which is often weakened by disease progression and hospitalization.
- Conditions
- Cardiac Amyloidosis
- Being tested
- Targeted Shiatsu
- Keywords
- Cardiac amyloidosis - Targeted Shiatsu - pain
- Medical subject headings
- Amyloid Neuropathies, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted ShiatsuOther
demonstrate the beneficial impact targeted Shiatsu compared with a "comfort" Shiatsu
| Study group | Role | What they receive |
|---|---|---|
| Shiatsu | Experimental | Comfort Shiatsu: 39
Targeted Shiatsu: 39 Receives: Other: Targeted Shiatsu |
| without Shiatsu | Active comparator | patients with cardiac amyloidosis with severe symptoms Receives: Other: Targeted Shiatsu |
What is being measured
The primary outcome is the main question the study is designed to answer.
EESE-R (ESAS) TOTAL SYMPTOM SCORE AT 48 HOURS AFTER THIRD SHIATSU SESSION
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).
Measured: 31 days ± 1 day
Secondary outcomes (1)
MEASUREMENT PHYSIO, SUDOSCAN, E-PATCH
Description of secondary endpoint: 20% improvement in heart rate variability measured with the e-patch. Continuous measurement [0-48H] after first Shiatsu session
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start12 Mar 2024
- Primary completion12 Apr 2026 (estimated)
- Study completion12 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac AmyloidosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197165
- Sponsor's protocol ID
- APHP230424
- Acronym
- AMYLO-SHIATSU
- Status last verified
- Jan 2026
- First submitted
- 26 Dec 2023
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amylo-Shiatsu-Acute-Chronic: Effects of Shiatsu on Symptoms and Quality of Life of Amyloidosis Patients
- ClinicalTrials.gov ID
- NCT06197165
- Acronym / sponsor ID
- AMYLO-SHIATSU / APHP230424
- Conditions
- Cardiac Amyloidosis
- Keywords
- Cardiac amyloidosis - Targeted Shiatsu - pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 12 Apr 2026 (estimated)
- Study completion
- 12 Apr 2026 (estimated)
- First posted
- 9 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Population:
The study will involve patients diagnosed with amyloidosis (TTR, WT, AL) who are hospitalized or followed at the Centre de Référence Amyloses-Cardiaques (Cardiogen branch) at the CHU Henri Mondor in Créteil, France. A total of 108 patients will participate: 78 in the Shiatsu group (26 AL, 26 TTR, 26 WT), 39 in the Comfort Shiatsu group, 39 in the Targeted Shiatsu group, and 30 in the No Shiatsu group. The expected inclusion rate per center per month is 4.5, with a study duration of 2 years.
Primary Endpoint:
Reduction in total ESAS symptom score 48 hours after the third Shiatsu session.
Secondary Endpoints:
A 20% improvement in heart rate variability measured with the e-patch. A 20% improvement in skin conductance and variability measured with the SUDOSCAN.
Overall score on the EQ-5D scale. Overall score on the MINNESOTA scale. A 2-point improvement in the symptom-specific questionnaire corresponding to the symptom targeted by Shiatsu (e.g., dyspnea, digestive disorders, pain).
Improvement in at least one global score on the BFI, HADS, or LSEQ scales.
Inclusion Visit (D0):
Patients will be offered participation during their routine care consultation. Once consent is obtained, the patient will complete several questionnaires (MINNESOTA, EESE-R, EQ-5D, QCD, BFI, LSEQ, HADS). Measurements with the SUDOSCAN will be taken, and the e-patch will be applied for 48 hours. For Shiatsu participants, randomization will be conducted by an open-label CRA independent of the study, and the results will be sent to the Shiatsu specialists (targeted or comfort). The patient will then receive a Shiatsu session accordingly.
Research Follow-Up Visits:
Visit 1 (D1): A second SUDOSCAN measurement will be taken 24 hours post-Shiatsu session or inclusion for the no-Shiatsu group. Follow-up measurements will be taken at 24 and 48 hours.
Visit 2 (D2): A third SUDOSCAN measurement will be taken 48 hours post-Shiatsu or inclusion. Patients will complete the EESE-R and modified TAQ questionnaires.
Visit 3 (D7±1 day): The Shiatsu group will receive a second Shiatsu session and complete the modified TAQ questionnaire 48 hours later (D9±1 day).
Visit 4 (D14±1 day): The Shiatsu group will receive a third Shiatsu session and complete the modified TAQ questionnaire 48 hours after the session (D16±1 day).
Telephone Visits:
Contact 1 (D16±1 day): Telephone follow-up 48 hours after the third Shiatsu session, during which patients will complete various questionnaires (MINNESOTA, EESE-R, EQ-5D, QCD, BFI, LSEQ, HADS, modified TAQ).
Contact 2 (D31±1 day): A second telephone follow-up to complete the same set of questionnaires.
Conclusion:
The expected benefits for patients include an improvement in quality of life and symptoms (e.g., appetite, nausea, digestive disorders, sleep, fatigue, anxiety, depression, pain) as well as balancing of the autonomic nervous system (ANS), which is often weakened by disease progression and hospitalization.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shiatsu | Experimental | Other: Targeted ShiatsuComfort Shiatsu: 39 Targeted Shiatsu: 39 |
| without Shiatsu | Active comparator | Other: Targeted Shiatsupatients with cardiac amyloidosis with severe symptoms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years ;
- Patient with :
- 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);
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted Shiatsudemonstrate the beneficial impact targeted Shiatsu compared with a "comfort" Shiatsu | Other | Shiatsu, without Shiatsu |
Primary outcome
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).
1 secondary outcome
MEASUREMENT PHYSIO, SUDOSCAN, E-PATCH
Time frame: 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No. DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted Shiatsu in people with Cardiac Amyloidosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JULIE POMPOUGNAC, Dr (00 33 6 35 37 61 63, julie.pompougnac@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EESE-R (ESAS) TOTAL SYMPTOM SCORE AT 48 HOURS AFTER THIRD SHIATSU SESSION (time frame: 31 days ± 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.