Study of Medical Ultrasound for Rhizarthrosis (SUR): study protocol for a randomized controlled single-center pilot-trial

Markus Bock, Andreas Eisenschenk, Heiko Lorenzen, Martin Lautenbach, Markus Bock, Andreas Eisenschenk, Heiko Lorenzen, Martin Lautenbach

Abstract

Background: Rhizarthrosis (trapeziometacarpal osteoarthritis) is the second most common site of osteoarthritis in the hand affecting 10-30% of adults over the age of 50. Up to four times as many women as men have rhizarthrosis. Clinical symptoms include functional disability of the thumb, pain, joint swelling, and reduced strength. The first carpometacarpal joint is pivotal in the opposition of the thumb and allows a high degree in flexibility to humans. Current therapies focus mainly on surgical strategies, which should be considered in advanced, therapy-resistant stages to relieve pain and improve function. However, conservative treatment methods are urgently required in presurgical stages. The efficacy of conservative treatment options for rhizarthrosis, which are intended to preserve function, joint integrity and to relieve pain, has not been adequately studied. In the clinical study protocol presented here, we investigate the efficacy of multimodal hand therapy versus therapeutic ultrasound versus combination therapy with both hand therapy and therapeutic ultrasound.

Methods: This study is a single-center, randomized, controlled, parallel-group pilot trial. One hundred fifty patients with rhizarthrosis and current disease activity will be randomized to one of three conservative interventions over 6 months. Interventions are (1) multimodal hand therapy (2) therapeutic ultrasound, and (3) combination therapy with both hand therapy and ultrasound therapy. The primary outcome measure is the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire score after 6 months. Secondary endpoints are changes in pain, quality of life, disability progression, and changes of hand function. Safety will also be assessed.

Discussion: Clinical data suggest that multimodal hand therapy may improve functionality and reduce pain in rhizarthrosis. Clinical data regarding therapeutic ultrasound are not available. Clinical evidence is lacking. This study is the first clinical study investigating the effects of multimodal hand therapy in direct comparison to therapeutic ultrasound and to a combination therapy with both hand therapy and ultrasound therapy for rhizarthrosis.

Trial registration: ClinicalTrials.gov; NCT04115085; Registered on September 30, 2019.

Keywords: Degeneration; Hand therapy; Rhizarthrosis; Therapeutic ultrasound; Thumb basal joint arthritis; Thumb carpometacarpal joint arthritis; Trapeziometacarpal osteoarthritis.

Conflict of interest statement

The authors declare that they have no competing interests. The final trial data set will be available to the investigators.

Figures

Fig. 1
Fig. 1
SUR study flow chart. SUR Study of Medical Ultrasound for Rhizarthrosis

References

    1. Zhang Y, Niu J, Kelly-Hayes M, Chaisson CE, Aliabadi P, Felson DT. Prevalence of symptomatic hand osteoarthritis and its impact on functional status among the elderly: The Framingham Study. Am J Epidemiol. 2002;156:1021–1027.
    1. Dahaghin S, Bierma-Zeinstra SMA, Ginai AZ, Pols HAP, Hazes JMW, Koes BW. Prevalence and pattern of radiographic hand osteoarthritis and association with pain and disability (the Rotterdam study) Ann Rheum Dis. 2005;64:682–687.
    1. Stamm T, van der Giesen F, Thorstensson C, Steen E, Birrell F, Bauernfeind B, et al. Patient perspective of hand osteoarthritis in relation to concepts covered by instruments measuring functioning: a qualitative European multicentre study. Ann Rheum Dis. 2009;68:1453–1460.
    1. Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010;26:355–369.
    1. Kingsbury SR, Gross HJ, Isherwood G, Conaghan PG. Osteoarthritis in Europe: impact on health status, work productivity and use of pharmacotherapies in five European countries. Rheumatology (Oxford) 2014;53:937–947.
    1. Wallace IJ, Worthington S, Felson DT, Jurmain RD, Wren KT, Maijanen H, et al. Knee osteoarthritis has doubled in prevalence since the mid-20th century. Proc Natl Acad Sci U S A. 2017;114:9332–9336.
    1. Haugen IK, Magnusson K, Turkiewicz A, Englund M. The prevalence, incidence, and progression of hand osteoarthritis in relation to body mass index, smoking, and alcohol consumption. J Rheumatol. 2017;44:1402–1409.
    1. Vina E, Kwoh C. Epidemiology of osteoarthritis: literature update. Curr Opin Rheumatol. 2018;30:160–167.
    1. Weiss A-PC, Goodman AD. Thumb basal joint arthritis. J Am Acad Orthop Surg. 2018;26:562–571.
    1. Sonne-Holm S, Jacobsen S. Osteoarthritis of the first carpometacarpal joint: a study of radiology and clinical epidemiology. Results from the Copenhagen Osteoarthritis Study. Osteoarthr Cartil. 2006;14:496–500.
    1. Moriatis Wolf J, Turkiewicz A, Atroshi I, Englund M. Prevalence of doctor-diagnosed thumb carpometacarpal joint osteoarthritis: an analysis of Swedish health care. Arthritis Care Res. 2014;66:961–965.
    1. Armstrong AL, Hunter JB, Davis TR. The prevalence of degenerative arthritis of the base of the thumb in post-menopausal women. J Hand Surg (Br) 1994;19:340–341.
    1. Wilder FV, Barrett JP, Farina EJ. Joint-specific prevalence of osteoarthritis of the hand. Osteoarthr Cartil. 2006;14:953–957.
    1. Palazzo C, Nguyen C, Lefevre-Colau M-M, Rannou F, Poiraudeau S. Risk factors and burden of osteoarthritis. Ann Phys Rehab Med. 2016;59:134–138.
    1. Martel-Pelletier J, Barr AJ, Cicuttini FM, Conaghan PG, Cooper C, Goldring MB, et al. Osteoarthritis. Nat Rev Dis Primers. 2016;2:1–18.
    1. Vermeulen GM, Slijper H, Feitz R, Hovius SER, Moojen TM, Selles RW. Surgical management of primary thumb carpometacarpal osteoarthritis: a systematic review. J Hand Surg [Am] 2011;36:157–169.
    1. Wajon A, Vinycomb T, Carr E, Edmunds I, Ada L. Surgery for thumb (trapeziometacarpal joint) osteoarthritis. Cochrane Database Syst Rev. 2017;2017(4):CD004631.
    1. Ganhewa AD, Wu R, Chae MP, Tobin V, Miller GS, Smith JA, et al. Failure rates of base of thumb arthritis surgery: a systematic review. J Hand Surg [Am] 2019;44:728–741.e10.
    1. Gravås EMH, Tveter AT, Nossum R, Eide REM, Klokkeide Å, Matre KH, et al. Non-pharmacological treatment gap preceding surgical consultation in thumb carpometacarpal osteoarthritis - a cross-sectional study. BMC Musculoskelet Disord. 2019;20:180.
    1. Spaans AJ, van Minnen LP, Kon M, Schuurman AH, Ton Schreuders AR, Ton Vermeulen GM. Conservative treatment of thumb base osteoarthritis: a systematic review. J Hand Surg [Am] 2015;40:16–21.e6.
    1. Poole JU, Pellegrini VD. Arthritis of the thumb basal joint complex. J Hand Ther. 2000;13:91–107.
    1. Egan MY, Brousseau L. Splinting for osteoarthritis of the carpometacarpal joint: a review of the evidence. Am J Occup Ther. 2007;61:70–78.
    1. Mahendira D, Towheed TE. Systematic review of non-surgical therapies for osteoarthritis of the hand: an update. Osteoarthr Cartil. 2009;17:1263–1268.
    1. Lue S, Koppikar S, Shaikh K, Mahendira D, Towheed TE. Systematic review of non-surgical therapies for osteoarthritis of the hand: an update. Osteoarthr Cartil. 2017;25:1379–1389.
    1. Mejjad O, Maheu E. Therapeutic trials in hand osteoarthritis: a critical review. Osteoarthr Cartil. 2000;8(Suppl A):S57–S63.
    1. Kroon FPB, Carmona L, Schoones JW, Kloppenburg M. Efficacy and safety of non-pharmacological, pharmacological and surgical treatment for hand osteoarthritis: a systematic literature review informing the 2018 update of the EULAR recommendations for the management of hand osteoarthritis. RMD Open. 2018;4:e000734.
    1. Kloppenburg M, Kroon FP, Blanco FJ, Doherty M, Dziedzic KS, Greibrokk E, et al. 2018 update of the EULAR recommendations for the management of hand osteoarthritis. Ann Rheum Dis. 2019;78:16–24.
    1. Villafañe JH, Cleland JA, Fernández-de-Las-Peñas C. The effectiveness of a manual therapy and exercise protocol in patients with thumb carpometacarpal osteoarthritis: a randomized controlled trial. J Orthop Sports Phys Ther. 2013;43:204–213.
    1. Bertozzi L, Valdes K, Vanti C, Negrini S, Pillastrini P, Villafañe JH. Investigation of the effect of conservative interventions in thumb carpometacarpal osteoarthritis: systematic review and meta-analysis. Disabil Rehabil. 2015;37:2025–2043.
    1. Østerås N, Kjeken I, Smedslund G, Moe RH, Slatkowsky-Christensen B, Uhlig T, et al. Exercise for hand osteoarthritis. Cochrane Database Syst Rev. 2017;1:CD010388.
    1. ter Haar G. Therapeutic ultrasound. Eur J Ultrasound. 1999;9:3–9.
    1. Robertson VJ, Baker KG. A review of therapeutic ultrasound: effectiveness studies. Phys Ther. 2001;81:1339–1350.
    1. Draper DO, Klyve D, Ortiz R, Best TM. Effect of low-intensity long-duration ultrasound on the symptomatic relief of knee osteoarthritis: a randomized, placebo-controlled double-blind study. J Orthop Surg Res. 2018;13:257.
    1. Loyola-Sánchez A, Richardson J, MacIntyre NJ. Efficacy of ultrasound therapy for the management of knee osteoarthritis: a systematic review with meta-analysis. Osteoarthr Cartil. 2010;18:1117–1126.
    1. Zeng C, Li H, Yang T, Deng Z-H, Yang Y, Zhang Y, et al. Effectiveness of continuous and pulsed ultrasound for the management of knee osteoarthritis: a systematic review and network meta-analysis. Osteoarthr Cartil. 2014;22:1090–1099.
    1. Rothenberg JB, Jayaram P, Naqvi U, Gober J, Malanga GA. The role of low-intensity pulsed ultrasound on cartilage healing in knee osteoarthritis: a review. PM R. 2017;9:1268–1277.
    1. Kamatsuki Y, Aoyama E, Furumatsu T, Miyazawa S, Maehara A, Yamanaka N, et al. Possible reparative effect of low-intensity pulsed ultrasound (LIPUS) on injured meniscus. J Cell Commun Signal. 2019;13:193–207.
    1. Kennedy CD, Manske MC, Huang JI. Classifications in brief: The Eaton-Littler classification of thumb carpometacarpal joint arthrosis. Clin Orthop Relat Res. 2016;474:2729–2733.
    1. Kaltenborn FM. Manual mobilization of the joints: the Kaltenborn method of joint examination and treatment. Norli: Oslo; 2006.
    1. Villafañe JH, Fernandez de-Las-Peñas C, Silva GB, Negrini S. Contralateral sensory and motor effects of unilateral Kaltenborn mobilization in patients with thumb carpometacarpal osteoarthritis: a secondary analysis. J Phys Ther Sci. 2014;26:807–812.
    1. Angst F, Schwyzer H-K, Aeschlimann A, Simmen BR, Goldhahn J. Measures of adult shoulder function: Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH) and its short version (QuickDASH), Shoulder Pain and Disability Index (SPADI), American Shoulder and Elbow Surgeons (ASES) Society standardized shoulder assessment form, Constant (Murley) Score (CS), Simple Shoulder Test (SST), Oxford Shoulder Score (OSS), Shoulder Disability Questionnaire (SDQ), and Western Ontario Shoulder Instability Index (WOSI) Arthritis Care Res. 2011;63(Suppl 11):S174–S188.
    1. Bot SDM, Terwee CB, van der Windt DAWM, Bouter LM, Dekker J, de Vet HCW. Clinimetric evaluation of shoulder disability questionnaires: a systematic review of the literature. Ann Rheum Dis. 2004;63:335–341.
    1. Michon M, Maheu E, Berenbaum F. Assessing health-related quality of life in hand osteoarthritis: a literature review. Ann Rheum Dis. 2011;70:921–928.
    1. Jia L, Wang Y, Chen J, Chen W. Efficacy of focused low-intensity pulsed ultrasound therapy for the management of knee osteoarthritis: a randomized, double blind, placebo-controlled trial. Sci Rep. 2016;6:35453.
    1. van Buuren S. Flexible imputation of missing data. 2. Boca Raton: CRC Press, Taylor & Francis Group; 2018.
    1. Hunter DJ, Bierma-Zeinstra S. Osteoarthritis. Lancet. 2019;393:1745–1759.
    1. Villafañe JH, Valdes K, Pedersini P, Berjano P. Thumb carpometacarpal osteoarthritis: a musculoskeletal physiotherapy perspective. J Bodyw Mov Ther. 2019;23:908–912.
    1. Watson T. Ultrasound in contemporary physiotherapy practice. Ultrasonics. 2008;48:321–329.
    1. Lee HJ, Paik N-J, Lim J-Y, Kim KW, Gong HS. The impact of digit-related radiographic osteoarthritis of the hand on grip-strength and upper extremity disability. Clin Orthop Relat Res. 2012;470:2202–2208.
    1. Hagen KB, Smedslund G, Østerås N, Jamtvedt G. Quality of community-based osteoarthritis care: a systematic review and meta-analysis. Arthritis Care Res. 2016;68:1443–1452.

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