Effectiveness of standardized ultrasound guided percutaneous treatment of lateral epicondylitis with application of autologous blood, dextrose or perforation only on pain: a study protocol for a multi-center, blinded, randomized controlled trial with a 1 year follow up

Abstract

Background In the treatment of Lateral Epicondylitis (LE) no single intervention concerning injection therapies has been proven to be the most effective with regard to pain reduction. In this trial 3 injection therapies (perforation with application of autologous blood, perforation with application of dextrose and perforation only) will be compared in a standardized and ultrasound guided way. The objective is to assess the effectiveness of these 3 injection therapies on pain, quality of life and functional recovery. By conducting this study, we hope to make a statement on the effectiveness of injection therapy in the treatment of LE. Hereby, unnecessary treatments can be avoided, a more universal method of treatment can be established and the quality of the treatment can be improved. Methods/design A multicenter, randomized controlled trial with a superiority design and 12 months follow-up will be conducted in four Dutch hospitals. One hundred sixty five patients will be recruited in the age of 18 to 65 years, with chronic symptomatic lateral epicondylitis lasting longer than 6 weeks, which have concordant pain during physical examination. Patients will be randomized by block randomization to one of the three treatment arms. The treatment will be blinded for patients and outcome assessors. The following three injection therapies are compared: perforation with application of autologous blood, perforation with application of dextrose and perforation only. Injections will be performed ultrasound guided in a standardized and automated way. The primary endpoint is: pain (change in ‘Visual Analogue Scale’). Secondary endpoints are quality of life and functional recovery. These measurements are collected at baseline, 8 weeks, 5 months and 1 year after treatment. Discussion When completed, this trial will provide evidence on the effectiveness of injection therapy in the treatment of lateral epicondylitis on pain, quality of life and functional recovery. In current literature proper comparison of the effectiveness of injectables for LE is questionable, due to the lack of standardization of the treatment. This study will overcome bias due to manually performed injection therapy. Trial registration This study is registered in the Trial Register ( www.trialregister.nl ) of the Dutch Cochrane centre. Trial ID; NTR4569. http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4569

Early Results of a Novel Treatment Technique with Autologous Blood for Chronic Lateral Epicondylitis

“…Presumably also due to the lack of a standardized injectable technique executed in a reproducible and controlled way. It seems like current choice and manner of treatment for lateral epicondylitis is mainly based on personal preferences of the treating physician [17,18]. Chronic lateral epicondylitis can lead to evident functional disability, which consequently, leads to high costs due to productivity loss and health care use [11].…”

“…In most cases, the injections are performed manually and blindly, with often no ultrasound guidance. Also, the amount and depth of the perforation is often not defined [17,18]. Therefore, comparison of results remains questionable.…”

“…In 2017, a new automatic injection device (ITEC device) which involves autologous blood has emerged as a promising treatment option in patients with chronic lateral epicondylitis. This device subsequently provides for a standardized injection technique which rules out manual differences [18]. The primary aim of this study is to evaluate the short-term effectiveness of ITEC within 3 months of treatment.…”

Efficacy of ultrasound therapy for the treatment of lateral elbow tendinopathy (the UCICLET Trial): study protocol for a three-arm, prospective, multicentre, randomised controlled trial

“…This change will come about through proposed evidence-based treatment guidelines. There have been some ongoing clinical trials on LET treatment in recent years, [47][48][49] and our prospective randomised controlled trial (RCT) proposes to complement and add to this relevant and much needed scientific effort.…”

Advancing frontiers in rheumatic and musculoskeletal imaging

“…The articles published in this Article Collection clearly show the efforts of researchers to find innovative applications of musculoskeletal imaging in clinical practice and to face the crucial challenges that remain in the interpretation and quality control of images. Indeed, highly performing diagnostic technologies are currently available to early diagnose and accurately monitor several musculoskeletal disorders [ 1 – 3 ], but also to guide personalized interventional therapeutic procedures tailored to the individual patients in the emerging process of precision medicine [ 4 – 7 ]. Among these new modalities, some are particularly promising and thereby subject to several lines of research in RMDs, including SPECT-CT and dual-energy CT [ 8 , 9 ], novel MRI sequences [ 10 – 12 ], high and ultra-high frequency ultrasound with effective tools like shear wave elastography [ 13 – 16 ].…”