SpondyloarthritisSFASPANCT05433168
Study Evaluating the Effectiveness of Shiatsu on Fatigue in Patients With Axial Spondyloarthritis
A study testing SHIATSU and DUMMY SHIATSU in people with Spondyloarthritis, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spondyloarthritis
- What is being tested?
- SHIATSU and DUMMY SHIATSU
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 20 Sep 2022to 10 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Cross-over Pilot Study Evaluating the Effectiveness of Shiatsu on Fatigue in Patients With Axial Spondyloarthritis
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:
Read more
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.
Read the 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.
- Conditions
- Spondyloarthritis
- Being tested
- SHIATSU, DUMMY SHIATSU
- Keywords
- SHIATSU, axial spondyloarthritis, FATIGUE, CROSS OVER STUDY
- Medical subject headings
- Spondylarthritis, Axial Spondyloarthritis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHIATSUProcedure or surgery
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 SHIATSUProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Procedure: SHIATSU; Procedure: DUMMY SHIATSU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Day 35
Secondary outcomes (44)
Global Pain Evaluation (EVN)
The EVA pain scale is a graduated ruler ranging from 0 to 10. 0 = no pain 10 = maximum imaginable pain Pain will be assessed by the patient at each visit. Show the differences in disease progression between the 2 treatment arms
Measured: Day 0
Global Pain Evaluation (EVN)
The EVA pain scale is a graduated ruler ranging from 0 to 10. 0 = no pain 10 = maximum imaginable pain Pain will be assessed by the patient at each visit. Show the differences in disease progression between the 2 treatment arms
Measured: Day 3
Global Pain Evaluation (EVN)
The EVA pain scale is a graduated ruler ranging from 0 to 10. 0 = no pain 10 = maximum imaginable pain Pain will be assessed by the patient at each visit. Show the differences in disease progression between the 2 treatment arms
Measured: Day 14
Global Pain Evaluation (EVN)
The EVA pain scale is a graduated ruler ranging from 0 to 10. 0 = no pain 10 = maximum imaginable pain Pain will be assessed by the patient at each visit. Show the differences in disease progression between the 2 treatment arms
Measured: Day 18
Global Pain Evaluation (EVN)
The EVA pain scale is a graduated ruler ranging from 0 to 10. 0 = no pain 10 = maximum imaginable pain Pain will be assessed by the patient at each visit. Show the differences in disease progression between the 2 treatment arms
Measured: Day 28
Global Pain Evaluation (EVN)
The EVA pain scale is a graduated ruler ranging from 0 to 10. 0 = no pain 10 = maximum imaginable pain Pain will be assessed by the patient at each visit. Show the differences in disease progression between the 2 treatment arms
Measured: Day 35
Global Pain Evaluation (EVN)
The EVA pain scale is a graduated ruler ranging from 0 to 10. 0 = no pain 10 = maximum imaginable pain Pain will be assessed by the patient at each visit. Show the differences in disease progression between the 2 treatment arms
Measured: Day 56
BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
This is a questionnaire to calculate the activity index of ankylosing spondylitis.
The intensity of 5 symptoms during the past week will be estimated, giving a score from 0 to 10, knowing that 0 means the absence of the symptom and 10 its presence in the highest degree 0 = no pain 10 = maximum imaginable pain Pain will be assessed by the patient at each visit.
Measured: Day 0
BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
This is a questionnaire to calculate the activity index of ankylosing spondylitis.
The intensity of 5 symptoms during the past week will be estimated, giving a score from 0 to 10, knowing that 0 means the absence of the symptom and 10 its presence in the highest degree 0 = no pain 10 = maximum imaginable pain Pain will be assessed by the patient at each visit.
Measured: Day 3
BASDAI Bath Ankylosing Spondylitis Disease Activity Index
This is a questionnaire to calculate the activity index of ankylosing spondylitis.
The intensity of 5 symptoms during the past week will be estimated, giving a score from 0 to 10, knowing that 0 means the absence of the symptom and 10 its presence in the highest degree 0 = no pain 10 = maximum imaginable pain Pain will be assessed by the patient at each visit.
Measured: Day 14
BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
This is a questionnaire to calculate the activity index of ankylosing spondylitis.
The intensity of 5 symptoms during the past week will be estimated, giving a score from 0 to 10, knowing that 0 means the absence of the symptom and 10 its presence in the highest degree 0 = no pain 10 = maximum imaginable pain Pain will be assessed by the patient at each visit.
Measured: Day 18
BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
This is a questionnaire to calculate the activity index of ankylosing spondylitis.
The intensity of 5 symptoms during the past week will be estimated, giving a score from 0 to 10, knowing that 0 means the absence of the symptom and 10 its presence in the highest degree 0 = no pain 10 = maximum imaginable pain Pain will be assessed by the patient at each visit.
Measured: Day 28
BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
This is a questionnaire to calculate the activity index of ankylosing spondylitis.
The intensity of 5 symptoms during the past week will be estimated, giving a score from 0 to 10, knowing that 0 means the absence of the symptom and 10 its presence in the highest degree 0 = no pain 10 = maximum imaginable pain Pain will be assessed by the patient at each visit.
Measured: Day 35
BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
This is a questionnaire to calculate the activity index of ankylosing spondylitis.
The intensity of 5 symptoms during the past week will be estimated, giving a score from 0 to 10, knowing that 0 means the absence of the symptom and 10 its presence in the highest degree 0 = no pain 10 = maximum imaginable pain Pain will be assessed by the patient at each visit. Show the differences in disease progression between the 2 treatment arms
Measured: Day 56
BASFI questionnaire (Bath ankylosing spondylitis functional index)
It was developed specifically to assess joint mobility in SpA. The BASFI reflects the functional impact, that is to say the inability to perform actions of daily life. For each of the ten activities, you must rate from 0 to 10 the ease or difficulty of performing them during the past month. 0 means completely easy, 10 means impossible. This score is an aid in monitoring ankylosing spondylitis.
Show the differences in disease progression between the 2 treatment arms
Measured: Day 0
BASFI questionnaire (Bath ankylosing spondylitis functional index)
It was developed specifically to assess joint mobility in SpA. The BASFI reflects the functional impact, that is to say the inability to perform actions of daily life. For each of the ten activities, you must rate from 0 to 10 the ease or difficulty of performing them during the past month. 0 means completely easy, 10 means impossible. This score is an aid in monitoring ankylosing spondylitis.
Show the differences in disease progression between the 2 treatment arms
Measured: Day 14
BASFI questionnaire (Bath ankylosing spondylitis functional index)
It was developed specifically to assess joint mobility in SpA. The BASFI reflects the functional impact, that is to say the inability to perform actions of daily life. For each of the ten activities, you must rate from 0 to 10 the ease or difficulty of performing them during the past month. 0 means completely easy, 10 means impossible. This score is an aid in monitoring ankylosing spondylitis.
Show the differences in disease progression between the 2 treatment arms
Measured: Day 28
BASFI questionnaire (Bath ankylosing spondylitis functional index)
It was developed specifically to assess joint mobility in SpA. The BASFI reflects the functional impact, that is to say the inability to perform actions of daily life. For each of the ten activities, you must rate from 0 to 10 the ease or difficulty of performing them during the past month. 0 means completely easy, 10 means impossible. This score is an aid in monitoring ankylosing spondylitis.
Show the differences in disease progression between the 2 treatment arms
Measured: Day 35
Short Form-36 (SF-36)
It is a self-assessment quality of life scale comprising 11 questions
Show the differences in disease progression between the 2 treatment arms for Change in quality of life assessed according to the following indexes:
Measured: Day 0
Short Form-36
It is a self-assessment quality of life scale comprising 11 questions
Show the differences in disease progression between the 2 treatment arms for Change in quality of life assessed according to the following indexes:
Measured: Day 14
Short Form-36
It is a self-assessment quality of life scale comprising 11 questions.
Show the differences in disease progression between the 2 treatment arms for Change in quality of life assessed according to the following indexes:
Measured: Day 28
Short Form-36
It is a self-assessment quality of life scale comprising 11 questions.
Show the differences in disease progression between the 2 treatment arms for Change in quality of life assessed according to the following indexes:
Measured: Day 35
AsQoL Questionnaire (Ankylosing Spondylitis Quality of Life Questionnaire)
Score validated in French in 2010(Pham et al. 2010), it is composed of 18 double-choice (yes/no) items. All the points obtained are added together and divided by the maximum possible total Show the differences in disease progression between the 2 treatment arms for Change in quality of life assessed according to the following indexes: AS Quality of Life (ASQOL)
Measured: Day 0
AsQoL Questionnaire (Ankylosing Spondylitis Quality of Life Questionnaire)
Score validated in French in 2010(Pham et al. 2010), it is composed of 18 double-choice (yes/no) items. All the points obtained are added together and divided by the maximum possible total Show the differences in disease progression between the 2 treatment arms for Change in quality of life assessed according to the following indexes: AS Quality of Life (ASQOL)
Measured: Day 14
AsQoL Questionnaire (Ankylosing Spondylitis Quality of Life Questionnaire)
Score validated in French in 2010(Pham et al. 2010), it is composed of 18 double-choice (yes/no) items. All the points obtained are added together and divided by the maximum possible total Show the differences in disease progression between the 2 treatment arms for Change in quality of life assessed according to the following indexes: AS Quality of Life (ASQOL)
Measured: Day 28
AsQoL Questionnaire (Ankylosing Spondylitis Quality of Life Questionnaire)
Score validated in French in 2010(Pham et al. 2010), it is composed of 18 double-choice (yes/no) items. All the points obtained are added together and divided by the maximum possible total Show the differences in disease progression between the 2 treatment arms for Change in quality of life assessed according to the following indexes: AS Quality of Life (ASQOL)
Measured: Day 35
BASMI measurement index
It allows to evaluate the mobility of the spine. It is composed of 5 items including: cervical rotation, tragus wall distance, lateral flexion of the spine, lumbar flexion and inter malleolar distance. The score for each item is added together to result in a rating out of 10.
Measured: Day 0
BASMI measurement index
It allows to evaluate the mobility of the spine. It is composed of 5 items including: cervical rotation, tragus wall distance, lateral flexion of the spine, lumbar flexion and inter malleolar distance. The score for each item is added together to result in a rating out of 10.
Measured: Day 35
SpA Patient Health Index (ASAS Health Index)
This self-assessment questionnaire measures functioning and health across 17 aspects of health and 9 environmental factors (EFs) in patients with SpA. The ASAS HI contains items covering the following categories: pain, emotional functions, sleep, sexual functions, mobility, autonomy and community life
Measured: Day 0
SpA Patient Health Index (ASAS Health Index)
This self-assessment questionnaire measures functioning and health across 17 aspects of health and 9 environmental factors (EFs) in patients with SpA. The ASAS HI contains items covering the following categories: pain, emotional functions, sleep, sexual functions, mobility, autonomy and community life
Measured: Day 14
SpA Patient Health Index (ASAS Health Index)
This self-assessment questionnaire measures functioning and health across 17 aspects of health and 9 environmental factors (EFs) in patients with SpA. The ASAS HI contains items covering the following categories: pain, emotional functions, sleep, sexual functions, mobility, autonomy and community life
Measured: Day 28
SpA Patient Health Index (ASAS Health Index)
This self-assessment questionnaire measures functioning and health across 17 aspects of health and 9 environmental factors (EFs) in patients with SpA. The ASAS HI contains items covering the following categories: pain, emotional functions, sleep, sexual functions, mobility, autonomy and community life
Measured: Day 35
Work Productivity Index (WPAI) (Work Productivity and activity Impairment questionnaire)
This is a self-administered questionnaire where the assessment is based on the patient's absenteeism, his presence and his difficulties in carrying out his work or his outside activities. The higher the score, the more the patient has difficulty
Measured: Day 0
Work Productivity Index (WPAI) (Work Productivity and activity Impairment questionnaire)
This is a self-administered questionnaire where the assessment is based on the patient's absenteeism, his presence and his difficulties in carrying out his work or his outside activities. The higher the score, the more the patient has difficulty
Measured: Day 14
Work Productivity Index (WPAI) (Work Productivity and activity Impairment questionnaire)
This is a self-administered questionnaire where the assessment is based on the patient's absenteeism, his presence and his difficulties in carrying out his work or his outside activities. The higher the score, the more the patient has difficulty
Measured: Day 28
Work Productivity Index (WPAI) (Work Productivity and activity Impairment questionnaire)
This is a self-administered questionnaire where the assessment is based on the patient's absenteeism, his presence and his difficulties in carrying out his work or his outside activities. The higher the score, the more the patient has difficulty
Measured: Day 35
Anxiety and Depression (HAD) scale
The HAD scale is an instrument used to screen for anxiety and depressive disorders. It comprises 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), thus allowing two scores to be obtained (maximum score for each score = 21)
Measured: Day 0
Anxiety and Depression (HAD) scale
The HAD scale is an instrument used to screen for anxiety and depressive disorders. It comprises 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), thus allowing two scores to be obtained (maximum score for each score = 21)
Measured: Day 14
Anxiety and Depression (HAD) scale
The HAD scale is an instrument used to screen for anxiety and depressive disorders. It comprises 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), thus allowing two scores to be obtained (maximum score for each score = 21)
Measured: Day 28
Anxiety and Depression (HAD) scale
The HAD scale is an instrument used to screen for anxiety and depressive disorders. It comprises 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), thus allowing two scores to be obtained (maximum score for each score = 21)
Measured: Day 35
Pittsburgh Sleep Quality Index (PSQI)
This index is used to assess the sleep quality of subjects over the past month. The 17 scoring items in this study were combined into six components: sleep quality, time to fall asleep, sleep time, sleep efficiency, sleep disorder, and daytime dysfunction.
Each component used a Likert4 score (scored from 0 to 3), and the scores were added to obtain a total of 0-21 points. The higher the PSQI index, the worse the quality of sleep. A PSQI >7 is considered indicative of a sleep disorder.
Measured: Day 0
Pittsburgh Sleep Quality Index (PSQI)
This index is used to assess the sleep quality of subjects over the past month. The 17 scoring items in this study were combined into six components: sleep quality, time to fall asleep, sleep time, sleep efficiency, sleep disorder, and daytime dysfunction.
Each component used a Likert4 score (scored from 0 to 3), and the scores were added to obtain a total of 0-21 points. The higher the PSQI index, the worse the quality of sleep. A PSQI >7 is considered indicative of a sleep disorder.
Measured: Day 14
Pittsburgh Sleep Quality Index (PSQI)
This index is used to assess the sleep quality of subjects over the past month. The 17 scoring items in this study were combined into six components: sleep quality, time to fall asleep, sleep time, sleep efficiency, sleep disorder, and daytime dysfunction.
Each component used a Likert4 score (scored from 0 to 3), and the scores were added to obtain a total of 0-21 points. The higher the PSQI index, the worse the quality of sleep. A PSQI >7 is considered indicative of a sleep disorder.
Measured: Day 28
Pittsburgh Sleep Quality Index (PSQI)
This index is used to assess the sleep quality of subjects over the past month. The 17 scoring items in this study were combined into six components: sleep quality, time to fall asleep, sleep time, sleep efficiency, sleep disorder, and daytime dysfunction.
Each component used a Likert4 score (scored from 0 to 3), and the scores were added to obtain a total of 0-21 points. The higher the PSQI index, the worse the quality of sleep. A PSQI >7 is considered indicative of a sleep disorder.
Measured: Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start20 Sep 2022
- Primary completion10 Dec 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SpondyloarthritisStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Monocentric randomized controlled cross-over trial with allocation of patients according to a ratio (1:1)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric LESPESSAILLES, PH, Principal investigator, CHR d'Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433168
- Sponsor's protocol ID
- CHRO-2021-14
- Acronym
- SFASPA
- Status last verified
- Dec 2025
- First submitted
- 21 Jun 2022
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37173568
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Cross-over Pilot Study Evaluating the Effectiveness of Shiatsu on Fatigue in Patients With Axial Spondyloarthritis
- ClinicalTrials.gov ID
- NCT05433168
- Acronym / sponsor ID
- SFASPA / CHRO-2021-14
- Conditions
- Spondyloarthritis
- Keywords
- SHIATSU, axial spondyloarthritis, FATIGUE, CROSS OVER STUDY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 27 Jun 2022 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Monocentric randomized controlled cross-over trial with allocation of patients according to a ratio (1:1)
| Arm | Type | Receives |
|---|---|---|
| SHIATSU GROUP | Experimental | Procedure: SHIATSU, Procedure: DUMMY SHIATSUThe 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 | Experimental | Procedure: SHIATSU, Procedure: DUMMY SHIATSUExercising 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| SHIATSUThe 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 or surgery | DUMMY SHIATSU GROUP, SHIATSU GROUP |
| DUMMY SHIATSUExercising 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 or surgery | DUMMY SHIATSU GROUP, SHIATSU GROUP |
Primary outcome
Percentage of patients responding to the FACIT Fatigue score
Time frame: Day 0
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)
Percentage of patients responding to the FACIT Fatigue score
Time frame: Day 14
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)
Percentage of patients responding to the FACIT Fatigue score
Time frame: Day 28
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)
Percentage of patients responding to the FACIT Fatigue score
Time frame: Day 35
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)
44 secondary outcomes
Global Pain Evaluation (EVN)
Time frame: Day 0
Global Pain Evaluation (EVN)
Time frame: Day 3
Global Pain Evaluation (EVN)
Time frame: Day 14
Global Pain Evaluation (EVN)
Time frame: Day 18
Global Pain Evaluation (EVN)
Time frame: Day 28
Global Pain Evaluation (EVN)
Time frame: Day 35
Global Pain Evaluation (EVN)
Time frame: Day 56
BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
Time frame: Day 0
BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
Time frame: Day 3
BASDAI Bath Ankylosing Spondylitis Disease Activity Index
Time frame: Day 14
BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
Time frame: Day 18
BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
Time frame: Day 28
BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
Time frame: Day 35
BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
Time frame: Day 56
BASFI questionnaire (Bath ankylosing spondylitis functional index)
Time frame: Day 0
BASFI questionnaire (Bath ankylosing spondylitis functional index)
Time frame: Day 14
BASFI questionnaire (Bath ankylosing spondylitis functional index)
Time frame: Day 28
BASFI questionnaire (Bath ankylosing spondylitis functional index)
Time frame: Day 35
Short Form-36 (SF-36)
Time frame: Day 0
Short Form-36
Time frame: Day 14
Short Form-36
Time frame: Day 28
Short Form-36
Time frame: Day 35
AsQoL Questionnaire (Ankylosing Spondylitis Quality of Life Questionnaire)
Time frame: Day 0
AsQoL Questionnaire (Ankylosing Spondylitis Quality of Life Questionnaire)
Time frame: Day 14
AsQoL Questionnaire (Ankylosing Spondylitis Quality of Life Questionnaire)
Time frame: Day 28
AsQoL Questionnaire (Ankylosing Spondylitis Quality of Life Questionnaire)
Time frame: Day 35
BASMI measurement index
Time frame: Day 0
BASMI measurement index
Time frame: Day 35
SpA Patient Health Index (ASAS Health Index)
Time frame: Day 0
SpA Patient Health Index (ASAS Health Index)
Time frame: Day 14
SpA Patient Health Index (ASAS Health Index)
Time frame: Day 28
SpA Patient Health Index (ASAS Health Index)
Time frame: Day 35
Work Productivity Index (WPAI) (Work Productivity and activity Impairment questionnaire)
Time frame: Day 0
Work Productivity Index (WPAI) (Work Productivity and activity Impairment questionnaire)
Time frame: Day 14
Work Productivity Index (WPAI) (Work Productivity and activity Impairment questionnaire)
Time frame: Day 28
Work Productivity Index (WPAI) (Work Productivity and activity Impairment questionnaire)
Time frame: Day 35
Anxiety and Depression (HAD) scale
Time frame: Day 0
Anxiety and Depression (HAD) scale
Time frame: Day 14
Anxiety and Depression (HAD) scale
Time frame: Day 28
Anxiety and Depression (HAD) scale
Time frame: Day 35
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Derived from this study: PubMed 37173568Bernardinelli 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Eric LESPESSAILLES, PH principal investigator
CHR d'Orléans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SHIATSU and DUMMY SHIATSU in people with Spondyloarthritis, run by Centre Hospitalier Régional d'Orléans 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 30 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients responding to the FACIT Fatigue score (time frame: Day 0). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05433168, which also lists 1 linked publication.
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 30 Dec 2025.