Clinical trial NCT05433168: Study Evaluating the Effectiveness of Shiatsu on Fatigue in Patients With Axial Spondyloarthritis
Official title: Randomized Cross-over Pilot Study Evaluating the Effectiveness of Shiatsu on Fatigue in Patients With Axial Spondyloarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spondyloarthritis
Keywords: SHIATSU
axial spondyloarthritis
FATIGUE
CROSS OVER STUDY
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Monocentric randomized controlled cross-over trial with allocation of patients according to a ratio (1:1)
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: To investigate the variations in the fatigue score (FACIF-F) after a shiatsu intervention (3 sessions) versus a sham shiatsu intervention (3 sessions) (control group).

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patient with a pathology that contraindicates the practice of shiatsu (evolving infectious skin pathology that would make shiatsu treatment difficult)
* 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

Primary outcomes:
measure: Percentage of patients responding to the FACIT Fatigue score
timeFrame: Day 0
measure: Percentage of patients responding to the FACIT Fatigue score
timeFrame: Day 14
measure: Percentage of patients responding to the FACIT Fatigue score
timeFrame: Day 28
measure: Percentage of patients responding to the FACIT Fatigue score
timeFrame: Day 35
Secondary outcomes:
measure: Global Pain Evaluation (EVN)
timeFrame: Day 0
measure: Global Pain Evaluation (EVN)
timeFrame: Day 3
measure: Global Pain Evaluation (EVN)
timeFrame: Day 14
measure: Global Pain Evaluation (EVN)
timeFrame: Day 18
measure: Global Pain Evaluation (EVN)
timeFrame: Day 28
measure: Global Pain Evaluation (EVN)
timeFrame: Day 35
measure: Global Pain Evaluation (EVN)
timeFrame: Day 56
measure: BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
timeFrame: Day 0
measure: BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
timeFrame: Day 3
measure: BASDAI Bath Ankylosing Spondylitis Disease Activity Index
timeFrame: Day 14
measure: BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
timeFrame: Day 18
measure: BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
timeFrame: Day 28
measure: BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
timeFrame: Day 35
measure: BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
timeFrame: Day 56
measure: BASFI questionnaire (Bath ankylosing spondylitis functional index)
timeFrame: Day 0
measure: BASFI questionnaire (Bath ankylosing spondylitis functional index)
timeFrame: Day 14
measure: BASFI questionnaire (Bath ankylosing spondylitis functional index)
timeFrame: Day 28
measure: BASFI questionnaire (Bath ankylosing spondylitis functional index)
timeFrame: Day 35
measure: Short Form-36 (SF-36)
timeFrame: Day 0
measure: Short Form-36
timeFrame: Day 14
measure: Short Form-36
timeFrame: Day 28
measure: Short Form-36
timeFrame: Day 35
measure: AsQoL Questionnaire (Ankylosing Spondylitis Quality of Life Questionnaire)
timeFrame: Day 0
measure: AsQoL Questionnaire (Ankylosing Spondylitis Quality of Life Questionnaire)
timeFrame: Day 14
measure: AsQoL Questionnaire (Ankylosing Spondylitis Quality of Life Questionnaire)
timeFrame: Day 28
measure: AsQoL Questionnaire (Ankylosing Spondylitis Quality of Life Questionnaire)
timeFrame: Day 35
measure: BASMI measurement index
timeFrame: Day 0
measure: BASMI measurement index
timeFrame: Day 35
measure: SpA Patient Health Index (ASAS Health Index)
timeFrame: Day 0
measure: SpA Patient Health Index (ASAS Health Index)
timeFrame: Day 14
measure: SpA Patient Health Index (ASAS Health Index)
timeFrame: Day 28
measure: SpA Patient Health Index (ASAS Health Index)
timeFrame: Day 35
measure: Work Productivity Index (WPAI) (Work Productivity and activity Impairment questionnaire)
timeFrame: Day 0
measure: Work Productivity Index (WPAI) (Work Productivity and activity Impairment questionnaire)
timeFrame: Day 14
measure: Work Productivity Index (WPAI) (Work Productivity and activity Impairment questionnaire)
timeFrame: Day 28
measure: Work Productivity Index (WPAI) (Work Productivity and activity Impairment questionnaire)
timeFrame: Day 35
measure: Anxiety and Depression (HAD) scale
timeFrame: Day 0
measure: Anxiety and Depression (HAD) scale
timeFrame: Day 14
measure: Anxiety and Depression (HAD) scale
timeFrame: Day 28
measure: Anxiety and Depression (HAD) scale
timeFrame: Day 35
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Day 0
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Day 14
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Day 28
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Day 35
Other outcomes:
Locations:
city: Orleans
country: France
facility: CHR d'ORLEANS
Study officials:
affiliation: CHR d'Orléans
name: Eric LESPESSAILLES, PH
role: PRINCIPAL_INVESTIGATOR
References: