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

Primary Purpose

Spondyloarthritis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
SHIATSU
DUMMY SHIATSU
Sponsored by
Centre Hospitalier Régional d'Orléans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spondyloarthritis focused on measuring SHIATSU, axial spondyloarthritis, FATIGUE, CROSS OVER STUDY

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHR d'ORLEANSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

SHIATSU GROUP

DUMMY SHIATSU GROUP

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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)
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)
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)
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)

Secondary Outcome Measures

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
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
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
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
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
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
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
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.
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.
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.
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.
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.
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.
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
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
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
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
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
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:
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:
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:
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:
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)
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)
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)
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)
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.
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.
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
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
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
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
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
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
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
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
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)
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)
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)
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)
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.
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.
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.
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.

Full Information

First Posted
June 21, 2022
Last Updated
December 27, 2022
Sponsor
Centre Hospitalier Régional d'Orléans
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1. Study Identification

Unique Protocol Identification Number
NCT05433168
Brief Title
Study Evaluating the Effectiveness of Shiatsu on Fatigue in Patients With Axial Spondyloarthritis
Acronym
SFASPA
Official Title
Randomized Cross-over Pilot Study Evaluating the Effectiveness of Shiatsu on Fatigue in Patients With Axial Spondyloarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2022 (Actual)
Primary Completion Date
March 20, 2024 (Anticipated)
Study Completion Date
October 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional d'Orléans

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondyloarthritis
Keywords
SHIATSU, axial spondyloarthritis, FATIGUE, CROSS OVER STUDY

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Monocentric randomized controlled cross-over trial with allocation of patients according to a ratio (1:1)
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SHIATSU GROUP
Arm Type
Experimental
Arm Description
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).
Arm Title
DUMMY SHIATSU GROUP
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
SHIATSU
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
DUMMY SHIATSU
Intervention Description
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
Primary Outcome Measure Information:
Title
Percentage of patients responding to the FACIT Fatigue score
Description
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)
Time Frame
Day 0
Title
Percentage of patients responding to the FACIT Fatigue score
Description
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)
Time Frame
Day 14
Title
Percentage of patients responding to the FACIT Fatigue score
Description
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)
Time Frame
Day 28
Title
Percentage of patients responding to the FACIT Fatigue score
Description
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)
Time Frame
Day 35
Secondary Outcome Measure Information:
Title
Global Pain Evaluation (EVN)
Description
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
Time Frame
Day 0
Title
Global Pain Evaluation (EVN)
Description
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
Time Frame
Day 3
Title
Global Pain Evaluation (EVN)
Description
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
Time Frame
Day 14
Title
Global Pain Evaluation (EVN)
Description
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
Time Frame
Day 18
Title
Global Pain Evaluation (EVN)
Description
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
Time Frame
Day 28
Title
Global Pain Evaluation (EVN)
Description
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
Time Frame
Day 35
Title
Global Pain Evaluation (EVN)
Description
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
Time Frame
Day 56
Title
BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
Description
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.
Time Frame
Day 0
Title
BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
Description
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.
Time Frame
Day 3
Title
BASDAI Bath Ankylosing Spondylitis Disease Activity Index
Description
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.
Time Frame
Day 14
Title
BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
Description
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.
Time Frame
Day 18
Title
BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
Description
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.
Time Frame
Day 28
Title
BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
Description
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.
Time Frame
Day 35
Title
BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
Description
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
Time Frame
Day 56
Title
BASFI questionnaire (Bath ankylosing spondylitis functional index)
Description
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
Time Frame
Day 0
Title
BASFI questionnaire (Bath ankylosing spondylitis functional index)
Description
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
Time Frame
Day 14
Title
BASFI questionnaire (Bath ankylosing spondylitis functional index)
Description
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
Time Frame
Day 28
Title
BASFI questionnaire (Bath ankylosing spondylitis functional index)
Description
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
Time Frame
Day 35
Title
Short Form-36 (SF-36)
Description
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:
Time Frame
Day 0
Title
Short Form-36
Description
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:
Time Frame
Day 14
Title
Short Form-36
Description
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:
Time Frame
Day 28
Title
Short Form-36
Description
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:
Time Frame
Day 35
Title
AsQoL Questionnaire (Ankylosing Spondylitis Quality of Life Questionnaire)
Description
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)
Time Frame
Day 0
Title
AsQoL Questionnaire (Ankylosing Spondylitis Quality of Life Questionnaire)
Description
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)
Time Frame
Day 14
Title
AsQoL Questionnaire (Ankylosing Spondylitis Quality of Life Questionnaire)
Description
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)
Time Frame
Day 28
Title
AsQoL Questionnaire (Ankylosing Spondylitis Quality of Life Questionnaire)
Description
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)
Time Frame
Day 35
Title
BASMI measurement index
Description
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.
Time Frame
Day 0
Title
BASMI measurement index
Description
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.
Time Frame
Day 35
Title
SpA Patient Health Index (ASAS Health Index)
Description
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
Time Frame
Day 0
Title
SpA Patient Health Index (ASAS Health Index)
Description
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
Time Frame
Day 14
Title
SpA Patient Health Index (ASAS Health Index)
Description
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
Time Frame
Day 28
Title
SpA Patient Health Index (ASAS Health Index)
Description
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
Time Frame
Day 35
Title
Work Productivity Index (WPAI) (Work Productivity and activity Impairment questionnaire)
Description
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
Time Frame
Day 0
Title
Work Productivity Index (WPAI) (Work Productivity and activity Impairment questionnaire)
Description
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
Time Frame
Day 14
Title
Work Productivity Index (WPAI) (Work Productivity and activity Impairment questionnaire)
Description
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
Time Frame
Day 28
Title
Work Productivity Index (WPAI) (Work Productivity and activity Impairment questionnaire)
Description
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
Time Frame
Day 35
Title
Anxiety and Depression (HAD) scale
Description
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)
Time Frame
Day 0
Title
Anxiety and Depression (HAD) scale
Description
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)
Time Frame
Day 14
Title
Anxiety and Depression (HAD) scale
Description
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)
Time Frame
Day 28
Title
Anxiety and Depression (HAD) scale
Description
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)
Time Frame
Day 35
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
Day 0
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
Day 14
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
Day 28
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
Day 35

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nathalie BERNARDINELLI
Phone
33.6.11.50.12.52
Email
aupointdequilibre@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric LESPESSAILLES, PH
Organizational Affiliation
CHR d'Orléans
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHR d'ORLEANS
City
Orleans
ZIP/Postal Code
45067
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric LESPESSAILLES, Ph
Email
eric.lespessailles@chr-orleans.fr
First Name & Middle Initial & Last Name & Degree
Eric LESPESSAILLES, Ph

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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