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Abstract
Background There is no consensus regarding the treatment of Achilles insertional tendinopathies. Eccentric training remains the main choice in the conservative treatment of this illness; however, the good results in the management of non-insertional Achilles tendinopathy were not replicated in the insertional condition. Low energy shock wave therapy has been described as an alternative to these patients, but has yet to be empirically tested.
Hypothesis Shock wave therapy, adjunctive to the eccentric strengthening protocol, will improve measures of pain and function.
Design Double blind, placebo-controlled, parallel groups, randomised clinical trial.
Materials and methods 93 patients with a diagnosis of chronic insertional tendinopathy, referred from primary or secondary healthcare services, will be assessed and enrolled in this study. They will be divided into two groups (randomised by sequentially numbered identical envelopes, which will be administered serially to participants), one containing the combination of low energy shock wave and eccentric exercises, as treatment and the other comprehending the exercises and the placebo treatment (an apparatus placed in the therapeutic head). The assessments will occur in 2, 4, 6, 12 and 24 weeks. Patients will be evaluated primarily by the Victorian Institute of Sport Assessment-Achilles questionnaire and secondarily by the visual analogue scale, Algometry, the American Orthopedic Foot and Ankle Society scale, the Foot and Ankle Outcome Score and the 12-item Short Form Health Survey. We will use comparison of two proportions via relative frequency analysis, the Pearson Correlation the χ2 test and the analysis of variance for statistical analyses.
Discussion This study intends to demonstrate if the association of the eccentric exercise programme with the shock wave therapy can produce good results regarding the treatment of the Achilles insertional tendinopathy. In an attempt to prevent the high costs and complications associated with the surgical intervention, we will try to prove this combination as a viable therapeutic option in the conservative management of this prevalent condition. The strengths of the study are the design and the novelty of the combination of methods. The main limitation is the short follow-up course.
Ethics and dissemination The study is registered in the Clinical Trials database (protocol number: 8094833648737701) and was approved by the University Ethics Committee (number: 1373481).
Trial registration number 8094833648737701 (NCT02757664); Pre-results.
- achilles
- tendinopathy
- insertional
- shock wave
- eccentric
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Footnotes
Contributors NSBM was the main researcher. FF and JCB participated in co-orientation and study design. SJMI participated in co-orientation, writing and study design. FTM took part in co-orientation, writing and data collecting. PRDidS and BSdS took part in shock-wave application and implementation. OLC participated in literature revision and writing. GP participated in Visa-A translation to Portuguese and implementation. BTA was the medical student enrolled in the project, took part in implementation and data collecting. MJST took part in main orientation, literature revision, writing, study design and paper submissions. All authors contributed to refinement of the study protocol and approved the final manuscript.
Funding Study being conducted in São Paulo Federal University (UNIFESP), São Paulo—SP, Brazil.
Competing interests None declared.
Ethics approval Sao Paulo Federal University Ethics Committee (protocol number: 1373481).
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Results, technical appendix, statistical code and data set will be openly available through a DOI. Non-digital data supporting this study will be stored by the corresponding author at the Sao Paulo Federal University. Details of how to request access to these data will be provided in the final document.