NCT05433168Completed
Study Evaluating the Effectiveness of Shiatsu on Fatigue in Patients With Axial Spondyloarthritis
Randomized Cross-over Pilot Study Evaluating the Effectiveness of Shiatsu on Fatigue in Patients With Axial Spondyloarthritis
Source: ClinicalTrials.gov · Last updated 30 Dec 2025
Brief summary (registry, in English)
Spondyloarthritis is a potentially serious disease with reduced life expectancy. Even if the clinical presentation is eminently variable from one patient to another, the most frequently encountered manifestations such as inflammatory spinal pain, peripheral arthritis or even extra-articular involvement of the disease all represent disabling symptoms, origin of pain, temporary or in some cases permanent functional incapacity, but also general repercussions on daily life (asthenia, reactive depressive syndrome, etc.) which require a multidisciplinary approach, involving several medical, paramedical and other stakeholders, The objective of treatment is to improve quality of life, to control symptoms and inflammation, to prevent structural damage, particularly in peripheral damage, to preserve or restore functional capacities, autonomy and social participation of patients with spondyloarthritis. 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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 72 (actual)
- First submitted
- 21 Jun 2022
- Start date
- 20 Sept 2022
- Primary completion date
- 10 Dec 2024
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Diseases
- Ankylosing spondylitis
- NCT number
- NCT05433168
What you commit to
- Study type: Interventional
- Participants enrolled: 72
- From 20 Sept 2022 to the primary completion date, 10 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous shiatsu treatment
Other illness
- Patient with an uncontrolled epileptic or psychotic condition which, in the opinion of the investigator, would interfere with the smooth running of the study
Other
- Patient with a pathology that contraindicates the practice of shiatsu (evolving infectious skin pathology that would make shiatsu treatment difficult)
- 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
Who the study is looking for
- The patients with spondyloarthritis meeting the ASAS criteria and followed in the rheumatology department of the Orléans Regional Hospital Center.
- Men and women aged 18 to 70
- Patients with digital or visual analog rating scale ≥ 3 on the 1st question of the BASDAI
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Orléans Coordinator of this site? Confirm its status | Orléans | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.