Dataset Information

Does additional extracorporeal shock wave therapy improve the effect of isolated percutaneous radiofrequency coblation in patients with insertional Achilles tendinopathy? Study protocol for a randomized controlled clinical trial.

ABSTRACT:

Background

No conclusive evidence recommends a prior treatment for insertional Achilles tendinopathy (IAT). It is theorized that both percutaneous radiofrequency coblation and extracorporeal shockwave therapy (ESWT) relieve pain within the insertion. However, no clinical evidence shows that either treatment promotes the regeneration of the tendon or if the combination of these 2 interventions offers better function and less pain than one therapy.

Methods

The study is a randomized, controlled trial with patients allocated in a 1:1 ratio to one of two parallel groups. Patients with insertional Achilles tendinopathy who are not satisfied with the effect of conservative treatment will be screened. A minimum of 38 patients will be enrolled after deciding to participate in the trial on an informed basis. Then the intervention group and the control group perform radial ESWT and sham-ESWT respectively at 6 months after percutaneous radiofrequency coblation. The primary outcome will be the Victorian Institute of Sports Assessment Achilles (VISA-A) Score. Secondary outcome measures will be Foot and Ankle Outcome Score (FAOS) scale, visual analog scale (VAS), Tegner Score, and MRI ultra-short echo time (UTE) T2* value. The assessments will occur in 6 months, 1 year, and 2 years, post-operatively. The differences between the 2 groups will be conducted as intention-to-treat basis.

Discussion

We aim to investigate if radiofrequency coblation associated with ESWT can provide more encouraging imaging findings as well as functional and clinical outcomes regarding the treatment of the IAT comparing to the single radiofrequency coblation treatment.

Trial registration

ChiCTR1800017898; pre-results. Registered on 20 August 2018.

SUBMITTER: Song YJ

PROVIDER: S-EPMC9641927 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

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Publications

Does additional extracorporeal shock wave therapy improve the effect of isolated percutaneous radiofrequency coblation in patients with insertional Achilles tendinopathy? Study protocol for a randomized controlled clinical trial.

Song Yu-Jie YJ Xuan Wen-Kai WK Hua Ying-Hui YH

Trials 20221107 1

<h4>Background</h4>No conclusive evidence recommends a prior treatment for insertional Achilles tendinopathy (IAT). It is theorized that both percutaneous radiofrequency coblation and extracorporeal shockwave therapy (ESWT) relieve pain within the insertion. However, no clinical evidence shows that either treatment promotes the regeneration of the tendon or if the combination of these 2 interventions offers better function and less pain than one therapy.<h4>Methods</h4>The study is a randomized, ...[more]

PMID: 36345020

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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:BackgroundThere 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.HypothesisShock wave therapy, adjunctive to the eccentric strengthening protocol, will improve measures of pain and function.DesignDouble blind, placebo-controlled, parallel groups, randomised clinical trial.Materials and methods93 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.DiscussionThis 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 disseminationThe study is registered in the Clinical Trials database (protocol number: 8094833648737701) and was approved by the University Ethics Committee (number: 1373481).Trial registration number8094833648737701 (NCT02757664); Pre-results.

Project description:BackgroundExtracorporeal shockwave therapy (ESWT) is used commonly to treat pain and function in Achilles tendinopathy (AT). The aim of this study was to synthesize the evidence from (non-) randomized controlled trials, to determine the clinical effectiveness of ESWT for mid-portion Achilles tendinopathy (mid-AT) and insertional Achilles tendinopathy (ins-AT) separately.MethodsWe searched PubMed/Medline, Embase (Ovid), and Cochrane Central, up to January 2021. Unpublished studies and gray literature were searched in trial registers (ACTRN, ChiCTR, ChiCtr, CTRI, DRKS, EUCTR, IRCT, ISRCTN, JPRN UMIN, ClinicalTrials.gov, NTR, TCTR) and databases (OpenGrey.eu, NARCIS.nl, DART-Europe.org, OATD.org). Randomized controlled trials (RCTs) and non-randomized controlled clinical trials (CCTs) were eligible when investigating the clinical effectiveness of ESWT for chronic mid-AT or chronic ins-AT. We excluded studies that focused on treating individuals with systemic conditions, and studies investigating mixed cohorts of mid-AT and ins-AT, when it was not possible to perform a subgroup analysis for both clinical entities separately. Two reviewers independently performed the study selection, quality assessment, data extraction, and grading of the evidence levels. Discrepancies were resolved through discussion or by consulting a third reviewer when necessary.ResultsWe included three RCTs on mid-AT and four RCTs on ins-AT. For mid-AT, moderate quality of evidence was found for the overall effectiveness of ESWT compared to standard care, with a pooled mean difference (MD) on the VISA-A of 9.08 points (95% CI 6.35-11.81). Subgroup analysis on the effects of ESWT additional to standard care for mid-AT resulted in a pooled MD on the VISA-A of 10.28 points (95% CI 7.43-13.12). For ins-AT, we found very low quality of evidence, indicating that, overall, ESWT has no additional value over standard care, with a standardized mean difference (SMD) of - 0.02 (95% CI - 0.27 to 0.23). Subgroup analysis to determine the effect of ESWT additional to standard care for ins-AT showed a negative effect (SMD - 0.29; 95% CI - 0.56 to - 0.01) compared to standard care alone.ConclusionsThere is moderate evidence supporting the effectiveness of ESWT additional to a tendon loading program in mid-AT. Evidence supporting the effectiveness of ESWT for ins-AT is lacking.Trial registrationPROSPERO Database; No. CRD42021236107.

Project description:BackgroundPercutaneous Zadek osteotomy (ZO) has emerged as a surgical treatment of insertional Achilles tendinopathy (IAT) over the last decade. Existing literature is limited regarding the comparison of this approach with the more established, open ZO technique. This systematic review aims to evaluate and compare the current data on open vs percutaneous ZO approaches to help set evidence-based guidelines.MethodsA systematic literature search was performed using the keywords (Zadek osteotomy) OR (Keck and Kelly osteotomy) OR (dorsal closing wedge calcaneal osteotomy) OR (Haglund Deformity) OR (Haglund Syndrome) OR (Insertional Achilles Tendinopathy) and MeSH terms Osteotomy, Calcaneus, Syndrome, Insertional, Achilles tendon, and Tendinopathy. Our search included the following databases: PubMed, Embase, and the Cochrane Library. The PRISMA protocol and the Cochrane Handbook guidelines were followed. All studies included were published from 2009 to 2024 and included the use of open or percutaneous approaches of ZO for the treatment of IAT with at least a 12-month follow-up. The MINORS score criteria were used to evaluate the strength and quality of studies.ResultsA total of 17 studies were reviewed, including 611 subjects and 625 ZO procedures. Of these procedures, 81 (11%) subjects had a percutaneous and 544 (89%) subjects had an open ZO. The mean follow-up time was 16.1 months for patients treated with percutaneous ZO and 36.1 months for patients treated with open ZO. Both open and percutaneous studies included in this review showed postoperative improvements in AOFAS, FFI, VISA-A, and VAS scores in patients with IAT. The reported complication rate was 5.8% among patients treated with percutaneous ZO and 10.2% among patients treated with open ZO.ConclusionPercutaneous ZO is an emerging approach with substantially fewer documented cases compared with the open ZO. Both percutaneous and open ZO appear to be relatively effective treatments for insertional Achilles tendinopathy with Haglund's deformity. The lower complication rates reported for percutaneous ZO is encouraging. Further investigation with more subjects undergoing percutaneous ZO is clearly needed.

Dataset Information

Does additional extracorporeal shock wave therapy improve the effect of isolated percutaneous radiofrequency coblation in patients with insertional Achilles tendinopathy? Study protocol for a randomized controlled clinical trial.

Background

Methods

Discussion

Trial registration

Publications

Does additional extracorporeal shock wave therapy improve the effect of isolated percutaneous radiofrequency coblation in patients with insertional Achilles tendinopathy? Study protocol for a randomized controlled clinical trial.

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