PMID- 37173568
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231113
IS  - 2198-6576 (Print)
IS  - 2198-6584 (Electronic)
IS  - 2198-6576 (Linking)
VI  - 10
IP  - 4
DP  - 2023 Aug
TI  - Effectiveness of Shiatsu on Fatigue in Patients with Axial Spondyloarthritis: 
      Protocol for a Randomized Cross-Over Pilot Study.
PG  - 1107-1117
LID - 10.1007/s40744-023-00558-w [doi]
AB  - INTRODUCTION: Spondyloarthritis (SpA) is a serious chronic inflammatory 
      rheumatism implying different painful and crippling symptoms that require a 
      multidisciplinary approach for the patient. Fatigue is one of the less well 
      treated symptoms, even if its repercussion on everyday life is noticeable. 
      Shiatsu is a Japanese preventive and well-being therapy that aims to promote 
      better health. However, the effectiveness of shiatsu in SpA-associated fatigue 
      has never been studied yet in a randomized study. METHODS AND ANALYSIS: We 
      describe the design of SFASPA (Etude pilote randomisee en cross-over evaluant 
      l'efficacite du Shiatsu sur la FAtigue des patients atteints de SPondyloarthrite 
      Axiale), a single-center, randomized controlled cross-over trial with allocation 
      of patients according to a ratio (1:1) evaluating the effectiveness of shiatsu in 
      SpA-associated fatigue. The sponsor is the Regional Hospital of Orleans, France. 
      The two groups of 60 patients each will receive three "active" shiatsu and three 
      sham shiatsu treatments (120 patients, 720 shiatsu). The wash-out period between 
      the active and the sham shiatsu treatments is 4 months. PLANNED OUTCOMES: The 
      primary outcome is the percentage of patients responding to the FACIT-fatigue 
      score. A response to fatigue is defined as an improvement, i.e., an increase 
      of >/= 4 points in the FACIT-fatigue score, which corresponds to the "minimum 
      clinically important difference" (MCID). Differences in the evolution of activity 
      and impact of the SpA will be assessed on several secondary outcomes. An 
      important aim of this study is also to gather material for further trials with 
      higher proof of evidence. TRIAL REGISTRATION: NCT05433168, date of registration, 
      June 21st, 2022 (clinicaltrials.gov).
CI  - (c) 2023. The Author(s).
FAU - Bernardinelli, Nathalie
AU  - Bernardinelli N
AD  - Syndicat des Professionnels de Shiatsu, Shiatsu Specialist, Poissy, France.
FAU - Valery, Antoine
AU  - Valery A
AD  - Department of Medical Informatics and Statistics, Regional Hospital of Orleans, 
      Orleans, France.
FAU - Barrault, Denys
AU  - Barrault D
AD  - IPROS, University Hospital Center of Orleans, Orleans, France.
FAU - Dorland, Jean-Marc
AU  - Dorland JM
AD  - Shiatsu Specialist, Orleans, France.
FAU - Palut, Patricia
AU  - Palut P
AD  - IPROS, University Hospital Center of Orleans, Orleans, France.
FAU - Toumi, Hechmi
AU  - Toumi H
AD  - Department of Rheumatology, University Hospital Center of Orleans, Orleans, 
      France.
AD  - Translational Medicine Research Platform, PRIMMO, University Hospital Center of 
      Orleans, Orleans, France.
AD  - Regional Hospital of Orleans, 14 Avenue de L'Hopital, 45067, Orleans Cedex 2, 
      France.
FAU - Lespessailles, Eric
AU  - Lespessailles E
AUID- ORCID: 0000-0003-1009-8518
AD  - Department of Rheumatology, University Hospital Center of Orleans, Orleans, 
      France. eric.lespessailles@chr-orleans.fr.
AD  - Translational Medicine Research Platform, PRIMMO, University Hospital Center of 
      Orleans, Orleans, France. eric.lespessailles@chr-orleans.fr.
AD  - Regional Hospital of Orleans, 14 Avenue de L'Hopital, 45067, Orleans Cedex 2, 
      France. eric.lespessailles@chr-orleans.fr.
LA  - eng
SI  - ClinicalTrials.gov/NCT05433168
PT  - Journal Article
DEP - 20230512
PL  - England
TA  - Rheumatol Ther
JT  - Rheumatology and therapy
JID - 101674543
PMC - PMC10326191
OTO - NOTNLM
OT  - Cross-over
OT  - Fatigue
OT  - Randomized controlled trial
OT  - Shiatsu
OT  - Spondyloarthritis
COIS- Nathalie Bernardinelli, Antoine Valery, Denys Barrault, Jean-Marc Dorland, 
      Patricia Palut, Hechmi Toumi, Eric Lespessailles have nothing to disclose Denys 
      Barrault and Patricia Palut are now affiliated with IPROS, University Hospital 
      Center of Orleans, Orleans, France.
EDAT- 2023/05/13 15:13
MHDA- 2023/05/13 15:14
PMCR- 2023/05/12
CRDT- 2023/05/12 23:27
PHST- 2023/03/17 00:00 [received]
PHST- 2023/04/24 00:00 [accepted]
PHST- 2023/05/13 15:14 [medline]
PHST- 2023/05/13 15:13 [pubmed]
PHST- 2023/05/12 23:27 [entrez]
PHST- 2023/05/12 00:00 [pmc-release]
AID - 10.1007/s40744-023-00558-w [pii]
AID - 558 [pii]
AID - 10.1007/s40744-023-00558-w [doi]
PST - ppublish
SO  - Rheumatol Ther. 2023 Aug;10(4):1107-1117. doi: 10.1007/s40744-023-00558-w. Epub 
      2023 May 12.