Platelet-rich plasma versus corticosteroid injection for treatment of trigger finger: study protocol for a prospective randomized triple-blind placebo-controlled trial

Samuli Aspinen, Panu H Nordback, Turkka Anttila, Susanna Stjernberg-Salmela, Jorma Ryhänen, Jussi Kosola, Samuli Aspinen, Panu H Nordback, Turkka Anttila, Susanna Stjernberg-Salmela, Jorma Ryhänen, Jussi Kosola

Abstract

Background: Trigger finger is a common hand disorder that limits finger range of motion and causes pain and snapping of the affected finger. Trigger finger is caused by an imbalance of the tendon sheath and the flexor tendon. The initial treatment is generally a local corticosteroid injection around the first annular (A1) pulley. However, it is not unusual that surgical release of the A1 pulley is required. Moreover, adverse events after local corticosteroid injection or operative treatment may occur. Platelet-rich plasma (PRP) has been shown to be safe and to reduce symptoms in different tendon pathologies, such as DeQuervain's disease. However, the effects of PRP on trigger finger have not been studied. The aim of this single-center triple-blind randomized controlled trial is to study whether PRP is non-inferior to corticosteroid injection in treating trigger finger. The secondary outcome is to assess the safety and efficacy of PRP in comparison to placebo.

Methods: The trial is designed as a randomized, controlled, patient-, investigator-, and outcome assessor-blinded, single-center, three-armed 1:1:1 non-inferiority trial. The patients with clinical symptoms of trigger finger will be randomly assigned to treatment with PRP, corticosteroid, or normal saline injection. The primary outcome is Patient-Rated Wrist Evaluation and symptom resolution. Secondary outcomes include Quick-Disabilities of the Arm, Shoulder and Hand; pain; grip strength; finger active range of motion; and complications. Appropriate statistical methods will be applied.

Discussion: We present a novel RCT study design on the use of PRP for the treatment of trigger finger compared to corticosteroid and normal saline injection. The results of the trial will indicate if PRP is appropriate for the treatment of trigger finger.

Trial registration: ClinicalTrials.gov NCT04167098 . Registered on November 18, 2019.

Keywords: Clinical trial; Platelet-rich plasma; Stenosing tenosynovitis; Trigger finger; Trigger thumb.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
CONSORT diagram of the trial
Fig. 2
Fig. 2
The schedule of enrolment, interventions, assessments, and data collection. PRP, platelet-rich plasma; PRWE, Patient-Rated Wrist Evaluation; Q-DASH, Quick-Disabilities of the Arm, Shoulder and Hand; ROM, finger active range of motion; VAS, Visual Analogue Scale. * = primary endpoint of the study
Fig. 3
Fig. 3
Kapandji thumb opposition score (0 = no opposition, 10 = maximal opposition)

References

    1. Peters-Veluthamaningal C, van der Windt DA, Winters JC, Meyboom-de Jong B. Corticosteroid injection for trigger finger in adults. Cochrane Database Syst Rev. 2009;(1):CD005617.
    1. Gorsche R, Wiley JP, Renger R, Brant R, Gemer TY, Sasyniuk TM. Prevalence and incidence of stenosing flexor tenosynovitis (trigger finger) in a meat-packing plant. J Occup Environ Med. 1998;40:556–560. doi: 10.1097/00043764-199806000-00008.
    1. Moore JS. Flexor tendon entrapment of the digits (trigger finger and trigger thumb) J Occup Environ Med. 2000;42:526–545. doi: 10.1097/00043764-200005000-00012.
    1. Fiorini HJ, Tamaoki MJ, Lenza M, Gomes Dos Santos JB, Faloppa F, Belloti JC. Surgery for trigger finger. Cochrane Database Syst Rev. 201820;2(2):CD009860.
    1. Stahl S, Kanter Y, Karnielli E. Outcome of trigger finger treatment in diabetes. J Diabetes Complicat. 1997;11:287–290. doi: 10.1016/S1056-8727(96)00076-1.
    1. Makkouk AH, Oetgen ME, Swigart CR, Dodds SD. Trigger finger: etiology, evaluation, and treatment. Curr Rev Musculoskelet Med. 2007;1:92–96. doi: 10.1007/s12178-007-9012-1.
    1. Blood TD, Morrell NT, Weiss AP. Tenosynovitis of the hand and wrist: a critical analysis review. JBJS Rev. 2016;29:4.
    1. Matthews A, Smith K, Read L, Nicholas J, Schmidt E. Trigger finger: an overview of the treatment options. JAAPA. 2019;32:17–21. doi: 10.1097/01.JAA.0000550281.42592.97.
    1. Lambert MA, Morton RJ, Sloan JP. Controlled study of the use of local steroid injection in the treatment of trigger finger and thumb. J Hand Surg Br. 1992;17:69–70. doi: 10.1016/0266-7681(92)90014-S.
    1. Murphy D, Failla JM, Koniuch MP. Steroid versus placebo injection for trigger finger. J Hand Surg Am. 1995;20:628–631. doi: 10.1016/S0363-5023(05)80280-1.
    1. Peters-Veluthamaningal C, Winters JC, Groenier KH, Jong BM-D. Corticosteroid injections effective for trigger finger in adults in general practice: a double-blinded randomised placebo controlled trial. Ann Rheumatic Dis. 2007;67:1262–1266. doi: 10.1136/ard.2007.073106.
    1. Huisstede BM, Gladdines S, Manon S, Randsdorp MS, Koes BW. Effectiveness of conservative, surgical, and postsurgical interventions for trigger finger, Dupuytren disease, and De Quervain disease: a systematic review. Arch Phys Med Rehabil. 2018;99:1635–1649. doi: 10.1016/j.apmr.2017.07.014.
    1. Ma S, Wang C, Li J, Zhang Z, Yu Y, Lv F. Efficacy of corticosteroid injection for treatment of trigger finger: a meta-analysis of randomized controlled trials. J Investig Surg. 2019;32:433–441. doi: 10.1080/08941939.2018.1424970.
    1. Amirfeyz R, McNinch R, Watts A, Rodrigues J, Davis TRC, Glassey N, Bullock J. Evidence-based management of adult trigger digits. J Hand Surg Eur Vol. 2017;42:473–480. doi: 10.1177/1753193416682917.
    1. Fitzpatrick J, Bulsara M, Zheng MH. The effectiveness of platelet-rich plasma in the treatment of tendinopathy: a meta-analysis of randomized controlled clinical trials. Am J Sports Med. 2016;45:226–233. doi: 10.1177/0363546516643716.
    1. Barile A, La Marra A, Arrigoni F, Mariani S, Zugaro L, Splendiani A, et al. Anaesthetics, steroids and platelet-rich plasma (PRP) in ultrasound-guided musculoskeletal procedures. BJR. 2016;89:20150355. doi: 10.1259/bjr.20150355.
    1. Peerbooms JC, Sluimer J, Bruijn DJ, Gosens T. Positive effect of an autologous platelet concentrate in lateral epicondylitis in a double-blind randomized controlled trial. Am J Sports Med. 2010;38:255–262. doi: 10.1177/0363546509355445.
    1. Singh P, Madanipour S, Bhamra JS, Gill I. A systematic review and meta-analysis of platelet-rich plasma versus corticosteroid injections for plantar fasciopathy. Int Orthopaedics (SICOT) 2017;41:1169–1181. doi: 10.1007/s00264-017-3470-x.
    1. Fitzpatrick J, Bulsara MK, O’Donnell J, Zheng MH. Leucocyte-rich platelet-rich plasma treatment of gluteus medius and minimus tendinopathy: a double-blind randomized controlled trial with 2-year follow-up. Am J Sports Med. 2019;47:1130–1137. doi: 10.1177/0363546519826969.
    1. Le ADK, Enweze L, DeBaun MR, Dragoo JL. Current clinical recommendations for use of platelet-rich plasma. Curr Rev Musculoskelet Med. 2018;11:624–634. doi: 10.1007/s12178-018-9527-7.
    1. Redler A, Proietti L, Mazza D, Koverech G, Vadala A, De Carli A, Ferretti A. Rupture of the patellar tendon after platelet-rich plasma treatment: a case report. Clin J Sport Med. 2020;30:e20–e22.
    1. Ballard TNS, Kozlow JH. Trigger finger in adults. CMAJ. 2015;188:61. doi: 10.1503/cmaj.150225.
    1. Brinks A, Koes BW, Volkers AC, Verhaar JA, Bierma-Zeinstra SM. Adverse effects of extra-articular corticosteroid injections: a systematic review. BMC Musculoskelet Disord. 2010;11:206.
    1. Bruijnzeel H, Neuhaus V, Fostvedt S, Jupiter JB, Mudgal CS, Ring DC. Adverse events of open A1 pulley release for idiopathic trigger finger. J Hand Surg. 2012;37:1650–1656. doi: 10.1016/j.jhsa.2012.05.014.
    1. MacDermid JC, Turgeon T, Richards RS, Beadle M, Roth JH. Patient rating of wrist pain and disability: a reliable and valid measurement tool. J Orthop Trauma. 1998;12:577–86.
    1. Sandelin H, Jalanko T, Huhtala H, Lassila H, Haapala J, Helkamaa T. Translation and validation of the Finnish version of the patient-rated wrist evaluation questionnaire (PRWE) in patients with acute distal radius fracture. Scand J Surg. 2016;105:204–210. doi: 10.1177/1457496915613649.
    1. Beaton DE, Wright JG, Katz JN. Development of the QuickDASH. J Bone Joint Surg. 2005;87:1038–1046.
    1. Hacklin E, Timlin S, Madanat R, Strandberg N, Aro H. DASH-kyselykaavakkeen suomentaminen ja kulttuuriadaptaatio. Suomen Ortopedia ja Traumatologia. 2009;32:252–254.
    1. Haefeli M, Elfering M. Pain assessment. Eur Spine J. 2006;15:S17–S24. doi: 10.1007/s00586-005-1044-x.
    1. Massy-Westropp N, Ahern M, Krishnan J. A visual analogue scale for assessment of the impact of rheumatoid arthritis in the hand: validity and repeatability. J Hand Ther. 2005;18:30–33. doi: 10.1197/j.jht.2004.10.003.
    1. Kapandji A. Clinical test of apposition and counter-apposition of the thumb. Ann Chir Main. 1986;5:67–73. doi: 10.1016/S0753-9053(86)80053-9.
    1. Walenkamp MM, de Muinck Keizer RJ, Goslings JC, Vos LM, Rosenwasser MP, Schep NW. The minimum clinically important difference of the patient-rated wrist evaluation score for patients with distal radius fractures. Clin Orthop Relat Res. 2015;473:3235–3241. doi: 10.1007/s11999-015-4376-9.
    1. Sorensen AA, Howard D, Tan WH, Ketchersid J, Calfee RP. Minimal clinically important differences of 3 patient-rated outcomes instruments. J Hand Surg Am. 2013;38:641–649. doi: 10.1016/j.jhsa.2012.12.032.
    1. Järvinen TLN, Sihvonen R, Bhandari M, Sprague S, Malmivaara A, Paavola M, et al. Blinded interpretation of study results can feasibly and effectively diminish interpretation bias. J Clin Epidemiol. 2014;67:769–772. doi: 10.1016/j.jclinepi.2013.11.011.
    1. Azur MJ, Stuart EA, Frangakis C, Leaf PJ. Multiple imputation by chained equations: what is it and how does it work? Int J Methods Psychiatr Res. 2011;20:40–49. doi: 10.1002/mpr.329.
    1. Jones I, Togashi R, Thomas Vangsness C., Jr The economics and regulation of PRP in the evolving field of orthopedic biologics. Curr Rev Musculoskelet Med. 2018;11:558–565. doi: 10.1007/s12178-018-9514-z.
    1. Man D, Plosker H, Winland-Brown JE. The use of autologous platelet-rich plasma (platelet gel) and autologous platelet-poor plasma (fibrin glue) in cosmetic surgery. Plast Reconstr Surg. 2001;107:238–239. doi: 10.1097/00006534-200101000-00038.
    1. Kia C, Baldino J, Bell R, Ramji A, Uyeki C, Mazzocca A. Platelet-rich plasma: review of current literature on its use for tendon and ligament pathology. Curr Rev Musculoskelet Med. 2018;11:566–572. doi: 10.1007/s12178-018-9515-y.
    1. Chen X, Jones IA, Park C, Vangsness CT., Jr The efficacy of platelet-rich plasma on tendon and ligament healing: a systematic review and meta-analysis with bias assessment. Am J Sports Med. 2017;46:2020–2032. doi: 10.1177/0363546517743746.
    1. Malahias MA, Roumeliotis L, Nikolaou VS, Chronopoulos E, Sourlas I, Babis GC. Platelet-rich plasma versus corticosteroid intra-articular injections for the treatment of trapeziometacarpal arthritis: a prospective randomized controlled clinical trial. Cartilage. 2018;20:1947603518805230.
    1. Ramesh R, Jeyaraman M, Prajwal GS. The prospective study on efficacy and functional outcome of autologous platelet rich plasma injection in musculoskeletal disorders. EC Orthopaedics. 2018;9(12):849–63.
    1. Shahid M, Kundra R. Platelet-rich plasma (PRP) for knee disorders. EFORT Open Rev. 2017;2:28–34. doi: 10.1302/2058-5241.2.160004.

Source: PubMed

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