Effectiveness of Shiatsu on Fatigue in Patients with Axial Spondyloarthritis: Protocol for a Randomized Cross-Over Pilot Study

Nathalie Bernardinelli, Antoine Valery, Denys Barrault, Jean-Marc Dorland, Patricia Palut, Hechmi Toumi, Eric Lespessailles, Nathalie Bernardinelli, Antoine Valery, Denys Barrault, Jean-Marc Dorland, Patricia Palut, Hechmi Toumi, Eric Lespessailles

Abstract

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 randomisée en cross-over évaluant l'efficacité 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).

Keywords: Cross-over; Fatigue; Randomized controlled trial; Shiatsu; Spondyloarthritis.

Conflict of interest statement

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.

© 2023. The Author(s).

Figures

Fig. 1
Fig. 1
Study design

References

    1. Prati C, Claudepierre P, Pham T, Wendling D. Mortality in spondylarthritis. Joint Bone Spine. 2011;78:466–470. doi: 10.1016/j.jbspin.2011.02.012.
    1. Bakland G, Gran JT, Nossent JC. Increased mortality in ankylosing spondylitis is related to disease activity. Ann Rheum Dis. 2011;70:1921–1925. doi: 10.1136/ard.2011.151191.
    1. Bakland G, Gran JT, Becker-Merok A, Nordvåg BY, Nossent JC. Work disability in patients with ankylosing spondylitis in Norway. J Rheumatol. 2011;38:479–484. doi: 10.3899/jrheum.100686.
    1. Wendling D, Claudepierre P, Prati C. Early diagnosis and management are crucial in spondyloarthritis. Joint Bone Spine. 2013;80:582–585. doi: 10.1016/j.jbspin.2013.03.003.
    1. Gossec L, Dougados M, D’Agostino M-A, Fautrel B. Fatigue in early axial spondyloarthritis. Results from the French DESIR cohort. Jt Bone Spine. 2016;83:427–431. doi: 10.1016/j.jbspin.2015.07.012.
    1. Pearson NA, Tutton E, Martindale J, Strickland G, Thompson J, Packham JC, et al. Qualitative interview study exploring the patient experience of living with axial spondyloarthritis and fatigue: difficult, demanding and draining. BMJ Open. 2022;12:e053958. doi: 10.1136/bmjopen-2021-053958.
    1. Deodhar AA, Mease PJ, Rahman P, Navarro-Compán V, Strand V, Hunter T, et al. Ixekizumab improves spinal pain, function, fatigue, stiffness, and sleep in radiographic axial Spondyloarthritis: COAST-V/W 52-week results. BMC Rheumatol. 2021;5:35. doi: 10.1186/s41927-021-00205-3.
    1. Deodhar A, Conaghan PG, Kvien TK, Strand V, Sherif B, Porter B, et al. Secukinumab provides rapid and persistent relief in pain and fatigue symptoms in patients with ankylosing spondylitis irrespective of baseline C-reactive protein levels or prior tumour necrosis factor inhibitor therapy: 2-year data from the MEASURE 2 study. Clin Exp Rheumatol. 2019;37:260–269.
    1. Deodhar A, Mease P, Rahman P, Navarro-Compán V, Marzo-Ortega H, Hunter T, et al. Ixekizumab improves patient-reported outcomes in non-radiographic axial spondyloarthritis: results from the coast-X trial. Rheumatol Ther. 2021;8:135–150. doi: 10.1007/s40744-020-00254-z.
    1. Strand V, Deodhar A, Alten R, Sullivan E, Blackburn S, Tian H, et al. Pain and fatigue in patients with ankylosing spondylitis treated with tumor necrosis factor inhibitors: multinational real-world findings. J Clin Rheumatol. 2021;27:e446–e455. doi: 10.1097/RHU.0000000000001544.
    1. Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586. doi: 10.1136/bmj.e7586.
    1. Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the functional assessment of cancer therapy (FACT) measurement system. J Pain Symptom Manage. 1997;13:63–74. doi: 10.1016/S0885-3924(96)00274-6.
    1. Garrett S, Jenkinson T, Kennedy LG, Whitelock H, Gaisford P, Calin A. A new approach to defining disease status in ankylosing spondylitis: the bath ankylosing spondylitis disease activity index. J Rheumatol. 1994;21:2286–2291.
    1. Pham T, van der Heijde DM, Pouchot J, Guillemin F. Development and validation of the French ASQoL questionnaire. Clin Exp Rheumatol. 2010;28:379–385.
    1. Kiltz U, van der Heijde D, Boonen A, Cieza A, Stucki G, Khan MA, et al. Development of a health index in patients with ankylosing spondylitis (ASAS HI): final result of a global initiative based on the ICF guided by ASAS. Ann Rheum Dis. 2015;74:830–835. doi: 10.1136/annrheumdis-2013-203967.
    1. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67:361–370. doi: 10.1111/j.1600-0447.1983.tb09716.x.
    1. Buysse DJ, Reynolds CF, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh sleep quality index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989;28:193–213. doi: 10.1016/0165-1781(89)90047-4.
    1. Jenkinson TR, Mallorie PA, Whitelock HC, Kennedy LG, Garrett SL, Calin A. Defining spinal mobility in ankylosing spondylitis (AS). The bath AS metrology index. J Rheumatol. 1994;21:1694–1698.
    1. Pilgaard T, Hagelund L, Stallknecht SE, Jensen HH, Esbensen BA. Severity of fatigue in people with rheumatoid arthritis, psoriatic arthritis and spondyloarthritis—Results of a cross-sectional study. PLoS ONE. 2019;14:e0218831. doi: 10.1371/journal.pone.0218831.
    1. epiR: Tools for the Analysis of Epidemiological Data: available 2022. [Assessed on Oct 05, 2022].
    1. Molassiotis A, Sylt P, Diggins H. The management of cancer-related fatigue after chemotherapy with acupuncture and acupressure: a randomised controlled trial. Complement Ther Med. 2007;15:228–237. doi: 10.1016/j.ctim.2006.09.009.
    1. Tsay S-L, Cho Y-C, Chen M-L. Acupressure and transcutaneous electrical acupoint stimulation in improving fatigue, sleep quality and depression in hemodialysis patients. Am J Chin Med. 2004;32:407–416. doi: 10.1142/S0192415X04002065.

Source: PubMed

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

3
Subskrybuj