Study Evaluating the Effectiveness of Shiatsu on Fatigue in Patients With Axial Spondyloarthritis

NCT05433168 | Completed

• 1 other identifier: CHRO-2021-14
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Spondyloarthritis

Keywords

SHIATSU; axial spondyloarthritis; FATIGUE; CROSS OVER STUDY

Outcome Measures

Primary Outcomes (4)

• 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. It is a short, easy to administer, 13-item tool that measures a person's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four-point Likert scale (4 = not at all tired to 0 = very tired)

  Day 0

• 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. It is a short, easy to administer, 13-item tool that measures a person's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four-point Likert scale (4 = not at all tired to 0 = very tired)

  Day 14

• 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. It is a short, easy to administer, 13-item tool that measures a person's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four-point Likert scale (4 = not at all tired to 0 = very tired)

  Day 28

• 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. It is a short, easy to administer, 13-item tool that measures a person's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four-point Likert scale (4 = not at all tired to 0 = very tired)

  Day 35

Secondary Outcomes (44)

• Global Pain Evaluation (EVN)

  Day 0

• Global Pain Evaluation (EVN)

  Day 3

• Global Pain Evaluation (EVN)

  Day 14

• Global Pain Evaluation (EVN)

  Day 18

• Global Pain Evaluation (EVN)

  Day 28

Study Arms (2)

SHIATSU GROUP

EXPERIMENTAL

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).

Procedure: SHIATSU; Procedure: DUMMY SHIATSU

DUMMY SHIATSU GROUP

EXPERIMENTAL

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.

Procedure: SHIATSU; Procedure: DUMMY SHIATSU

Interventions

SHIATSU PROCEDURE

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 GROUP; SHIATSU GROUP

DUMMY SHIATSU PROCEDURE

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; SHIATSU GROUP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

CHU Orléans

Orléans, 45067, France

Location

Related Publications (1)

• 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.

  PMID: 37173568 DERIVED

MeSH Terms

Conditions

Spondylarthritis; Axial Spondyloarthritis; Fatigue

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Spondylarthropathies; Ankylosis; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Eric LESPESSAILLES, PH

  CHR d'Orléans

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Monocentric randomized controlled cross-over trial with allocation of patients according to a ratio (1:1)

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: June 27, 2022
• Study Start: September 20, 2022
• Primary Completion: December 10, 2024
• Study Completion: December 10, 2024
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)