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Shock wave therapy associated with eccentric strengthening versus isolated eccentric strengthening for Achilles insertional tendinopathy treatment: a double-blinded randomised clinical trial protocol.

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 ?2 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.

SUBMITTER: Mansur NS

PROVIDER: S-EPMC5278235 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature

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Shock wave therapy associated with eccentric strengthening versus isolated eccentric strengthening for Achilles insertional tendinopathy treatment: a double-blinded randomised clinical trial protocol.

Mansur Nacime Salomão Barbachan NS Faloppa Flávio F Belloti João Carlos JC Ingham Sheila J McNeill SJ Matsunaga Fabio Teruo FT Santos Paulo Roberto Dias Dos PR Santos Bruno Schiefer Dos BS Carrazzone Oreste Lemos OL Peixoto Gabriel G Aoyama Bruno Takeshi BT Tamaoki Marcel Jun Sugawara MJ

BMJ open 20170127 1

<h4>Background</h4>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.<h4>Hypothesis</h4>Shock wave therapy, adjuncti ...[more]

PMID: 28132005

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Project description:BackgroundExtracorporeal shock wave therapy (ESWT) is a widely considered treatment option for Achilles tendinopathy. Line-focused ESWT is a novel technique treating a larger tendon area than point-focused ESWT. Monitoring capacities of clinical symptoms with ultrasound under ESWT treatment are unknown.HypothesisPoint- and line-focused ESWT have a superior outcome than placebo ESWT. ESWT leads to morphological tendon changes detectable with ultrasound.Study designSingle-blinded placebo-controlled randomized contolled trial.Level of evidenceLevel 1.MethodsThe study was conducted in 3 cohorts, namely ESWT point (n = 21), ESWT line (n = 24), and ESWT placebo (n = 21). Victorian Institute of Sports Assessment-Achilles (VISA-A) score was measured before the intervention (T0), after 6 weeks (T1), and after 24 weeks (T2). All cohorts performed daily physiotherapy for 24 weeks and received 4 sessions of point-focused, line-focused, or placebo ESWT in the first 6 weeks. Ultrasound was performed with B-mode, power Doppler, shear wave elastography (SWE) at T0 and T2 and with ultrasound tissue characterization (UTC) at T0, T1, and T2. Data were analyzed with a mixed analysis of variance and t test.ResultsThere was a significant VISA-A improvement over time for all groups (P < 0.001). ESWT point had the strongest VISA-A score improvement +23 (ESWT line: +18; ESWT placebo: +15), but there was no significant interaction between time and any of the groups: F(4, 116) = 1.393; P = 0.24. UTC, power Doppler, and B-mode could not show significant alterations over time. SWE revealed a significant increase of elastic properties for ESWT point in the insertion (t = -3.113, P = 0.03) and midportion (t = -2.627, P = 0.02) over time.ConclusionThere is a significant VISA-A score improvement for all study groups without a statistically significant benefit for ESWT point or ESWT line compared with ESWT placebo. Tendon adaptation could only be detected with SWE for ESWT point.Clinical relevanceThe present study could not detect any statistically relevant effect of ESWT compared to placebo. SWE is able to demonstrate tendon adaptation.

Project description:ObjectivesUltrasound often corroborates clinical diagnosis of Achilles tendinopathy (AT). Traditional measures assess macromorphological features or use qualitative grading scales, primarily focused within the free tendon. Shear wave imaging can non-invasively quantify tendon elasticity, yet it is unknown if proximal structures are affected by tendon pathology. The purpose of the study was to determine the characteristics of both traditional sonographic measures and regional shear wave speed (SWS) between limbs in patients with AT.MethodsTwenty patients with chronic AT were recruited. Traditional sonographic measures of tendon structure were measured. Regional SWS was collected in a resting ankle position along the entire length of the tendon bilaterally. SWS measures were extracted and interpolated across evenly distributed points corresponding to the free tendon (FT), soleus aponeurosis (SA), and gastrocnemius aponeurosis (GA). Comparisons were made between limbs in both traditional sonographic measures and regional SWS.ResultsSymptomatic tendons were thicker (10.2 (1.9) vs. 6.8 (1.8) mm; p < 0.001) and had more hyperemia (p = 0.001) and hypoechogenicity (p = 0.002) than the contralateral tendon. Regional SWS in the FT was lower in the symptomatic limb compared to the contralateral limb (11.53 [10.99, 12.07] vs. 10.97 [10.43, 11.51]; p = 0.03). No differences between limbs were found for the SA (p = 0.13) or GA (p = 0.99).ConclusionsLower SWS was only observed in the FT in AT patients, indicating that alterations in tendon elasticity associated with AT were localized to the FT and did not involve the proximal passive tendon structures.Key points• Baseline characteristics of a pilot sample of 20 subjects suffering from chronic Achilles tendinopathy showed differences in conventional sonographic measures of tendon thickness, qualitatively assessed hypoechogenicity, hyperemia, and quantitative measures of shear wave speed. • Regional shear wave speeds were lower in the free tendon but not in the proximal regions of the soleus or gastrocnemius aponeuroses in Achilles tendinopathy patients. • Using shear wave imaging to estimate tendon stiffness may prove beneficial for clinical validation studies to address important topics such as return to activity and the effectiveness of rehabilitation protocols.

Project description:BackgroundInsertional Achilles tendinopathy (IAT) is a common cause of chronic posterior heel pain. Surgical intervention reproducibly improves patients' pain and functional status. We hypothesized that patients older than 60 years would have similar improvements in pain and function and low rates of complications after surgery for IAT when compared to a younger cohort.MethodsRetrospective review of adult case series in patients undergoing surgical management of IAT. Patients were stratified into those 60 years and younger and those older than 60 years. Patients with prior or concomitant surgical procedures and revisions were excluded. Visual analog scale (VAS), Short Form-36 Physical Component Summary and Mental Component Summary (SF-36 PCS/MCS) scores, wound infection, and recurrence, defined as a redevelopment of heel pain in the operative extremity within 6 months, were assessed with a minimum follow-up of 12 months. Statistical analysis was performed using linear regression mixed models and χ2 analysis. Thirty-seven patients were enrolled, with 38 operative heels. The younger cohort had an average age of 49.1 (range, 26-60) years. The older group had an average age of 66.8 (range, 61-76) years.ResultsVAS and SF-36 PCS scores for the entire cohort significantly improved at 6 and 12 months postoperatively (P < .001). Postoperative SF-36 MCS scores for the cohort significantly improved only at 12 months (P < .001). No significant differences between the young and elderly were seen with regard to improvements in VAS and SF-36 PCS/MCS at 6 or 12 months postoperatively. Multiple linear regression models showed no significant difference between age groups and VAS score, SF-36 PCS/MCS, or change in pain scores after controlling for comorbidities. No significant difference in overall complication rates was seen between the 2 groups (4.9% vs 29.4%, P = .104). There was 1 recurrence of heel pain in the younger group and 4 recurrences of pain in the older group (23.5%) at 6 months, of which 2 resolved at 1 year. There was 1 case of a superficial wound infection requiring antibiotics in the older cohort (5.9%). No patients required surgical revision.ConclusionSurgical management of IAT in an older population produced similar improvements in clinical results when compared to a younger cohort, with no significant increase in postoperative complications.Level of evidenceLevel III, retrospective comparative series.

Dataset Information

Shock wave therapy associated with eccentric strengthening versus isolated eccentric strengthening for Achilles insertional tendinopathy treatment: a double-blinded randomised clinical trial protocol.

Publications

Shock wave therapy associated with eccentric strengthening versus isolated eccentric strengthening for Achilles insertional tendinopathy treatment: a double-blinded randomised clinical trial protocol.

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