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      Is Open Access

      Percutaneous Bioelectric Current Stimulation in the Treatment of Chronic Achilles Tendinopathy: Protocol for a Double-Blind, Placebo-Controlled Randomized Multicenter Trial

      research-article
      Author(s): , Dr med 1 , , , Prof Dr med 2 , , Dr med 3 , , Prof Dr med 4 , , Prof Dr med 5
      Editor(s):
      Other contributor(s): (Reviewer), (Reviewer)
      Publication date (Electronic):
      Journal: JMIR Research Protocols
      Publisher: JMIR Publications
      Keywords: Achilles tendinopathy, pain, PBCS, conservative treatment

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          Abstract

          Background

          The consensus for the optimal treatment strategy for chronic Achilles tendinopathy (AT) is still debated and treatment options are limited. This results in a significant medical need for more effective treatment options.

          Objective

          The aim of this study is to investigate the therapeutic effects of percutaneous bioelectric current stimulation (PBCS) on AT.

          Methods

          A multicenter, randomized, double-blind, placebo-controlled clinical trial will be conducted. A total of 72 participants with chronic (ie, >3 months) midpoint AT will be randomized and receive four PBCS sessions—either verum or placebo—over 3 weeks. Both groups will complete daily Achilles tendon loading exercises in addition to the intervention. Evaluation sessions will be completed at baseline and during the intervention (weeks 0-3). Self-reported outcome measures will be completed at follow-up at weeks 4, 12, 26, and 52. The primary outcomes are the Victorian Institute of Sports Assessment–Achilles questionnaire scores and statistical evaluation of intraindividual differences between baseline and 12-week evaluations after initial treatment of verum therapy compared to control. Secondary outcomes will assess Pain Disability Index scores; average pain, using the 11-point Numeric Rating Scale; return to sports; and use of emergency medication.

          Results

          The study began in May 2021. As of October 2022, we randomized 66 out of 72 participants. We anticipate completing recruitment by the end of 2022 and completing primary data analysis by March 2023.

          Conclusions

          The study will evaluate the effects of PBCS on pain, physical function, and clinical outcomes.

          Trial Registration

          German Clinical Trials Register DRKS00017293; https://tinyurl.com/mvz7s98k

          International Registered Report Identifier (IRRID)

          DERR1-10.2196/40894

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          Most cited references27

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          Acupuncture for Chronic Pain: Update of an Individual Patient Data Meta-Analysis

          Andrew Vickers, Emily A. Vertosick, George Lewith … (2017)
          Despite wide use in clinical practice, acupuncture remains a controversial treatment for chronic pain. Our objective was to update an individual patient data meta-analysis to determine the effect size of acupuncture for 4 chronic pain conditions. We searched MEDLINE and the Cochrane Central Registry of Controlled Trials randomized trials published up until December 31, 2015. We included randomized trials of acupuncture needling versus either sham acupuncture or no acupuncture control for nonspecific musculoskeletal pain, osteoarthritis, chronic headache, or shoulder pain. Trials were only included if allocation concealment was unambiguously determined to be adequate. Raw data were obtained from study authors and entered into an individual patient data meta-analysis. The main outcome measures were pain and function. An additional 13 trials were identified, with data received for a total of 20,827 patients from 39 trials. Acupuncture was superior to sham as well as no acupuncture control for each pain condition (all P < .001) with differences between groups close to .5 SDs compared with no acupuncture control and close to .2 SDs compared with sham. We also found clear evidence that the effects of acupuncture persist over time with only a small decrease, approximately 15%, in treatment effect at 1 year. In secondary analyses, we found no obvious association between trial outcome and characteristics of acupuncture treatment, but effect sizes of acupuncture were associated with the type of control group, with smaller effects sizes for sham controlled trials that used a penetrating needle for sham, and for trials that had high intensity of intervention in the control arm. We conclude that acupuncture is effective for the treatment of chronic pain, with treatment effects persisting over time. Although factors in addition to the specific effects of needling at correct acupuncture point locations are important contributors to the treatment effect, decreases in pain after acupuncture cannot be explained solely in terms of placebo effects. Variations in the effect size of acupuncture in different trials are driven predominantly by differences in treatments received by the control group rather than by differences in the characteristics of acupuncture treatment.
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            The VISA-A questionnaire: a valid and reliable index of the clinical severity of Achilles tendinopathy.

            J M Robinson, J L Cook, C Purdam … (2001)
            There is no disease specific, reliable, and valid clinical measure of Achilles tendinopathy. To develop and test a questionnaire based instrument that would serve as an index of severity of Achilles tendinopathy. Item generation, item reduction, item scaling, and pretesting were used to develop a questionnaire to assess the severity of Achilles tendinopathy. The final version consisted of eight questions that measured the domains of pain, function in daily living, and sporting activity. Results range from 0 to 100, where 100 represents the perfect score. Its validity and reliability were then tested in a population of non-surgical patients with Achilles tendinopathy (n = 45), presurgical patients with Achilles tendinopathy (n = 14), and two normal control populations (total n = 87). The VISA-A questionnaire had good test-retest (r = 0.93), intrarater (three tests, r = 0.90), and interrater (r = 0.90) reliability as well as good stability when compared one week apart (r = 0.81). The mean (95% confidence interval) VISA-A score in the non-surgical patients was 64 (59-69), in presurgical patients 44 (28-60), and in control subjects it exceeded 96 (94-99). Thus the VISA-A score was higher in non-surgical than presurgical patients (p = 0.02) and higher in control subjects than in both patient populations (p<0.001). The VISA-A questionnaire is reliable and displayed construct validity when means were compared in patients with a range of severity of Achilles tendinopathy and control subjects. The continuous numerical result of the VISA-A questionnaire has the potential to provide utility in both the clinical setting and research. The test is not designed to be diagnostic. Further studies are needed to determine whether the VISA-A score predicts prognosis.
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              What are the Main Running-Related Musculoskeletal Injuries?

              Alexandre Lopes, Luiz Carlos Hespanhol Junior, Simon Yeung … (2012)
              Background Musculoskeletal injuries occur frequently in runners and despite many studies about running injuries conducted over the past decades it is not clear in the literature what are the main running-related musculoskeletal injuries (RRMIs). Objective The aim of this study is to systematically review studies on the incidence and prevalence of the main specific RRMIs. Methods An electronic database search was conducted using EMBASE (1947 to October 2011), MEDLINE (1966 to October 2011), SPORTDiscus™ (1975 to October 2011), the Latin American and Caribbean Center on Health Sciences Information (LILACS) [1982 to October 2011] and the Scientific Electronic Library Online (SciELO) [1998 to October 2011] with no limits of date or language of publication. Articles that described the incidence or prevalence rates of RRMIs were considered eligible. Studies that reported only the type of injury, anatomical region or incomplete data that precluded interpretation of the incidence or prevalence rates of RRMIs were excluded. We extracted data regarding bibliometric characteristics, study design, description of the population of runners, RRMI definition, how the data of RRMIs were collected and the name of each RRMI with their rates of incidence or prevalence. Separate analysis for ultra-marathoners was performed. Among 2924 potentially eligible titles, eight studies (pooled n = 3500 runners) were considered eligible for the review. In general, the articles had moderate risk of bias and only one fulfilled less than half of the quality criteria established. Results A total of 28 RRMIs were found and the main general RRMIs were medial tibial stress syndrome (incidence ranging from 13.6% to 20.0%; prevalence of 9.5%), Achilles tendinopathy (incidence ranging from 9.1% to 10.9%; prevalence ranging from 6.2% to 9.5%) and plantar fasciitis (incidence ranging from 4.5% to 10.0%; prevalence ranging from 5.2% to 17.5%). The main ultra-marathon RRMIs were Achilles tendinopathy (prevalence ranging from 2.0% to 18.5%) and patellofemoral syndrome (prevalence ranging from 7.4% to 15.6%). Conclusion This systematic review provides evidence that medial tibia stress syndrome, Achilles tendinopathy and plantar fasciitis were the main general RRMIs, while Achilles tendinopathy and patellofemoral syndrome were the most common RRMIs for runners who participated in ultra-marathon races.
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                Author and article information

                Contributors
                Philipp Schröder:
                ORCID: https://orcid.org/0000-0001-5727-836X
                Columbus Health Products GmbHKasernenstr 1bDuesseldorf, 40213Germany49 0211866880ph.schroeder@mac.com
                Journal
                Journal ID (nlm-ta): JMIR Res Protoc
                Journal ID (iso-abbrev): JMIR Res Protoc
                Journal ID (publisher-id): ResProt
                Title: JMIR Research Protocols
                Publisher: JMIR Publications (Toronto, Canada )
                ISSN (Electronic): 1929-0748
                Publication date Collection: November 2022
                Publication date (Electronic): 11 November 2022
                Volume: 11
                Issue: 11
                Electronic Location Identifier: e40894
                Affiliations
                [1 ] Columbus Health Products GmbH Duesseldorf Germany
                [2 ] Department of Orthopedics Ruhr-University Bochum Düsseldorf Germany
                [3 ] Drabik Clinical Trial Support Münster Germany
                [4 ] Department of Anesthesiology Pain Clinic Hannover Medical School Hannover Germany
                [5 ] Meoclinic GmbH Berlin Germany
                Author notes
                Corresponding Author: Philipp Schröder ph.schroeder@ 123456mac.com
                Author information
                https://orcid.org/0000-0001-5727-836X
                https://orcid.org/0000-0003-4439-135X
                https://orcid.org/0000-0001-8413-7626
                https://orcid.org/0000-0002-3502-0023
                https://orcid.org/0000-0002-2002-2608
                Article
                Publisher ID: v11i11e40894
                DOI: 10.2196/40894
                PMC ID: 9700236
                PubMed ID: 36325808
                SO-VID: 43a67f1e-ae97-48c8-a262-b5dfd8873f40
                Copyright © ©Philipp Schröder, Albrecht Molsberger, Attyla Drabik, Matthias Karst, Harry Merk. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 11.11.2022.
                License:

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

                History
                Date received : 11 July 2022
                Date revision requested : 15 September 2022
                Date revision received : 21 October 2022
                Date accepted : 2 November 2022
                Categories
                Subject: Protocol
                Subject: Protocol

                Keywords: achilles tendinopathy,pain,pbcs,conservative treatment
                Data availability:
                Keywords: achilles tendinopathy, pain, pbcs, conservative treatment

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