Study Evaluating the Effectiveness of Shiatsu on Fatigue in Patients With Axial Spondyloarthritis
NCT ID: NCT05433168
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
72 participants
INTERVENTIONAL
2022-09-20
2024-12-10
Brief Summary
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In France, the main professional reference for shiatsu is the Syndicat des Professionnels de Shiatsu, which proposes the following definition to define shiatsu:
Shiatsu (finger pressure in Japanese) is an energetic manual discipline addressing the individual as a whole. Shiatsu is part of personal assistance. He receives himself, dressed in soft clothes. Shiatsu is a discipline of well-being and prevention for better health. Its objective is to correct both the energy flow (ki, blood, lymph, etc.) and the body structure (muscles, tendons, etc.) by applying rhythmic pressure to the whole body, most often with the inches. It is for everyone and at all ages. Its principle of action is to restore the free flow of Ki (qi, Energy) in the body.
Shiatsu is a set of pressures performed mainly with the thumbs and the palms of the hands on different areas of the body, often taking up the points of the acupuncture meridians. Shiatsu pressures can be (Ishizuka 1993; Kagotani 1984; Okamoto 2016):
* mobile in a given place and lasting 3 to 5 seconds: a phase of increasing pressure followed by a short holding time then release,
* static: same phases but with a hold time of up to approximately 1 minute or even longer.
To date, there is no treatment specifically targeting fatigue in axSpA. Indeed, the underlying mechanisms of fatigue in SpA remain poorly understood, and could for example involve pro-inflammatory cytokines and the inflammatory process, and/or psychological distress. The effectiveness of non-pharmacological interventions and in particular the care provided by shiatsu practitioners have not been the subject of studies evaluating, according to the criteria of evidence-based medicine, the benefit of this practice, particularly in the context of treatment of spondyloarthritis.
Detailed Description
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The primary endpoint will be the percentage of patients responding to the FACIT Fatigue score. A response to fatigue will be defined as an improvement, i.e. an increase of ≥ 4 points in the FACIT-F score corresponding to the minimum clinically important difference.
Monocentric randomized controlled cross-over trial with allocation of patients according to a ratio (1:1) The study will be offered prospectively and systematically to patients with spondyloarthritis meeting the inclusion criteria during a follow-up consultation or in a day hospital or traditional hospitalization in the rheumatology department.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
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SHIATSU GROUP
The patients will benefit from shiatsu treatments by a professional according to the shiatsu protocol developed by the Syndicate's evaluation commission Shiatsu Professionals (SPS).
SHIATSU
The patients will benefit from shiatsu treatments by a professional according to the shiatsu protocol developed by the Syndicate's evaluation commission Shiatsu Professionals (SPS).
DUMMY SHIATSU
Exercising a fake shiatsu is a real problem as opinions differ. The consensus of the different schools and styles of the technique is that shiatsu pressure is weight transfer. We are therefore going to remove this aspect from the SFASPA shiatsu protocol. The professional will run the same sequence of points, without any weight transfer, being only in contact with the receiver
DUMMY SHIATSU GROUP
Exercising a fake shiatsu is a real problem as opinions differ. The consensus of the different schools and styles of the technique is that shiatsu pressure is weight transfer. We are therefore going to remove this aspect from the SFASPA shiatsu protocol. The professional will run the same sequence of points, without any weight transfer, being only in contact with the receiver.
SHIATSU
The patients will benefit from shiatsu treatments by a professional according to the shiatsu protocol developed by the Syndicate's evaluation commission Shiatsu Professionals (SPS).
DUMMY SHIATSU
Exercising a fake shiatsu is a real problem as opinions differ. The consensus of the different schools and styles of the technique is that shiatsu pressure is weight transfer. We are therefore going to remove this aspect from the SFASPA shiatsu protocol. The professional will run the same sequence of points, without any weight transfer, being only in contact with the receiver
Interventions
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SHIATSU
The patients will benefit from shiatsu treatments by a professional according to the shiatsu protocol developed by the Syndicate's evaluation commission Shiatsu Professionals (SPS).
DUMMY SHIATSU
Exercising a fake shiatsu is a real problem as opinions differ. The consensus of the different schools and styles of the technique is that shiatsu pressure is weight transfer. We are therefore going to remove this aspect from the SFASPA shiatsu protocol. The professional will run the same sequence of points, without any weight transfer, being only in contact with the receiver
Eligibility Criteria
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Inclusion Criteria
* Men and women aged 18 to 70
* Patients with digital or visual analog rating scale ≥ 3 on the 1st question of the BASDAI
Exclusion Criteria
* Previous shiatsu treatment
* Inability to attend appointments for the duration of the study
* Pregnant or breastfeeding woman
* Refusal to participate in the study or to sign the consent
* Patients not affiliated or not beneficiaries of a social security scheme
* Person under guardianship or curatorship
* Patient with an uncontrolled epileptic or psychotic condition which, in the opinion of the investigator, would interfere with the smooth running of the study
18 Years
70 Years
ALL
No
Sponsors
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Centre Hospitalier Régional d'Orléans
OTHER
Responsible Party
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Principal Investigators
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Eric LESPESSAILLES, PH
Role: PRINCIPAL_INVESTIGATOR
CHR d'Orléans
Locations
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CHU Orléans
Orléans, , France
Countries
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References
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Bernardinelli N, Valery A, Barrault D, Dorland JM, Palut P, Toumi H, Lespessailles E. Effectiveness of Shiatsu on Fatigue in Patients with Axial Spondyloarthritis: Protocol for a Randomized Cross-Over Pilot Study. Rheumatol Ther. 2023 Aug;10(4):1107-1117. doi: 10.1007/s40744-023-00558-w. Epub 2023 May 12.
Other Identifiers
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CHRO-2021-14
Identifier Type: -
Identifier Source: org_study_id