Original Research Ultrasound Guidance Does Not Improve the Results of Shock Wave for Plantar Fasciitis or Calcific Achilles Tendinopathy: A Randomized Control Trial Masiiwa M. Njawaya, BMed, PGDipSportsMed,* Bassam Moses, MBBS, FRACGP,† David Martens, MBBS,‡ Jessica J. Orchard, LLB (Hons I), MPH,§ Tim Driscoll, MBBS, PhD,§ John Negrine, FRACS,{ and John W. Orchard, MD, PhD§ Abstract Objective: To establish whether the use of ultrasound to direct shock waves to the area of greater calcification in calcaneal enthesopathies was more effective than the common procedure of directing shock waves to the point where the patient has the most tenderness. Design: Two-armed nonblinded randomized control trial with allocation concealment. Setting: The Sports Clinic at Sydney University. Patients: Participants 18 years or older with symptomatic plantar fasciitis (PF) (with heel spur) or calcific Achilles tendinopathy (CAT). Seventy-four of 82 cases completed treatment protocol and 6-month follow-up. Interventions: Patients were randomized to receive either ultrasound-guided (UG) or patient-guided (PG) shock wave at weekly intervals over 3 to 5 weeks. Main Outcome Measures: Reduced pain on visual analog scale (VAS) and improved functional score on Maryland Foot Score (MFS) (for PF) or Victorian Institute of Sport Assessment-Achilles (VISA-A) (for CAT). Follow-up was at 6 weeks and 3 and 6 months. Results: Comparative 6-month improvements in MFS for the 47 PF cases were PG +20/100 and UG +14/100 (P 5 0.20). Comparative 6-month improvement in VISA-A score for the 27 CAT cases were PG +35/100 and UG +27/100 (P 5 0.37). Comparative (combined PF and CAT) 6-month improvement in VAS pain scores for all 38 PG cases were +38/100 with + 37/100 for all 36 UG shock wave cases. Conclusions: Although both treatment groups had good clinical outcomes in this study, results for the 2 study groups were almost identical. Clinical Relevance: This study shows that there is no major advantage in the addition of ultrasound for guiding shock waves when treating calcaneal enthesopathies (PF and CAT). Key Words: shock wave, plantar fasciitis, Achilles, calcaneal enthesopathy, tendinopathy, ultrasound guided (Clin J Sport Med 2017;0:1–7) INTRODUCTION Calcaneal (plantar and Achilles) spurs are prevalent in older people and more common in women than men younger Enthesopathy, “bone spurs,” and calcific tendinopathy are than 50 years.4 pathologies commonly associated with insertional heel Extracorporeal shock wave therapy (ESWT) (used in pain. Although the etiologies of the 2 major calcaneal medicine initially to treat kidney stones, with the assistance enthesopathies [plantar fasciitis (PF) and calcific Achilles of imaging guidance) is now a well-established treatment tendinopathy (CAT)] are thought to be different, there are modality in sports and musculoskeletal medicine. The most similarities in demographics, presentation, and chronicity. substantive evidence base exists for chronic PF, where a recent Calcification in tendinopathy refers to an abnormal de- meta-analysis of 11 high-quality randomized controlled trials position of calcium hydroxyapatite surrounded by in- showed efficacy of shock wave in reducing pain versus placebo flammation in the tendon.1 Itcanbeassociatedwith or physical therapy.5 It is not established whether shock wave substantial pain and impaired function in the affected area, is successful because of dissolution of calcification, mechano- although bone spurs in the heel can also be present in therapy to stimulate tendon healing, or neurophysiological asymptomatic cases. Plantar fascia heel spurs develop as pain reduction.1,6 Although there are multiple types and a consequence of degenerative changes that occur in the brands of musculoskeletal shock wave, recent systematic plantar fascia enthesis and calcification in the fascia.2,3 review has found that clinical results do not seem to vary by – Submitted for publication August 11, 2016; accepted January 10, 2017. shock wave type.7 9 Systemic reviews conclude that shock From the *Sydney East Sports Medicine and Orthopaedics, Sydney, New South Wales, wave in general is effective (for calcaneal enthesopathy), Australia; †The Sports Clinic, The University of Sydney, Sydney, Australia; ‡Sydney § affordable, and has a very low rate of complications or side Medical School, The University of Sydney, Sydney, Australia; Sydney School of Public 6,10 { effects. However, results and protocols of treatment have Health, The University of Sydney, Sydney, Australia; and Orthosports, Randwick, 6,11 Sydney, New South Wales, Australia. been variable. Dr. Njawaya and Dr. J. W. Orchard report non-financial support from Sonosite and In current clinical foot and ankle practice, shock wave DJO, during the conduct of the study. therapy is often aimed at the site of the patient’s pain. This is Corresponding Author: Masiiwa M. Njawaya, BMed, PGDipSportsMed, Sydney known as the patient-guided (PG) or biofeedback method. East Sports Medicine and Orthopaedics, Level 1, 101, and 102, 451 New South Studies have shown that pain in calcific tendinopathy does Head Road, Double Bay, Sydney, NSW 2028 ([email protected]). not necessarily correlate with area of calcification.12 Studies Copyright © 2017 Wolters Kluwer Health, Inc. All rights reserved. of calcification in the shoulder in particular have shown that http://dx.doi.org/10.1097/JSM.0000000000000430 navigation-guided shock wave to the site of calcification Volume 0· Number 0· Month 2017 www.cjsportmed.com 1 Copyright Ó 2017 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. M.M. Njawaya et al. (2017) Clin J Sport Med may be more effective in improving patient pain and blinding effectively ended. The shock wave treatment and function, as well as decreasing calcification seen on consultations were free of charge to the patient and radiological images.10,13,14 Navigation-guided shock wave performed by a practitioner at weekly intervals. Patients traditionally uses low-dose radiation x-ray (fluoroscopy) were required to complete a minimum of 3 and a maximum and sometimes ultrasound to identify and focus treatment of 5 treatments to have completed study requirements. This is on the area of calcification.15 in accordance with a recent systematic review showing This study attempted to establish whether the use of optimum extracorporeal shock wave therapy (ESWT) ultrasound to direct shock waves to the calcaneal enthesis or treatment protocol which requires a minimum of 3 treatment area of greater calcification is more or less effective than the sessions at 1-week intervals, with 2000 impulses per session.9 procedure of directing shock waves to the point where the There were 3 practitioners who delivered treatment over the patient has the most tenderness. We hypothesized that for duration of the study. All 3 were trained in the delivery of moderate depth occurrences of calcification (ie, PF with heel shock wave therapy and use of ultrasound. spur) that perhaps ultrasound-guided (UG) shock wave may Both the manufacturers of the shock wave and ultrasound be more effective, whereas for the most superficial occurrences units provided machines rent-free for the duration of the of calcification (ie, CAT), PG shock wave may be as effective. study. The ultrasound was a Sonosite M-Turbo (Sonosite, Inc., Bothell, Washington). The shock wave machine was METHODS a Chattanooga Intellect Radial Pressure Wave RPW (DJO Global LLC, Vista, California). Shock waves were delivered Subjects by a hand-held device placed on the patient’s skin. Coupling gel was used between the patient skin and the hand-held Between March 2012 and June 2013, eligible patients were device to allow transmission of the shock waves. The shock recruited. Emails and letters were sent to potential referrers wave machine was set to deliver 2000 radial pressure waves (community-based medical doctors or allied health care at a rate of 15 waves per second. Shock wave energy was practitioners) notifying them of the study and eligibility gradually increased from 1.4 to 1.8 bars using the machine’s criteria. To be eligible, patients needed to have (1) pain and automated built-in feature. The lower energy settings used impaired function in tissue under study (Achilles tendon or were as recommended by the manufacturer to ensure patient plantar fascia); (2) proven calcification or spur which was comfort. No local anesthetic was used, as participants in the visible on our study ultrasound machine; and (3) not had PG group needed to be able to point to the site of their pain a cortisone injection to the area in the previous 3 months. The for the study purposes. After treatments, patients could take use of cortisone injection was excluded as the short-term oral paracetamol (acetaminophen) or apply ice to the area if effects of cortisone can be quite powerful and might mask desired. treatment outcomes. Our study design was to evaluate the The initial study protocol planned inclusion of a third group effect of ultrasound on symptomatic heel spur irrespective of with calcific supraspinatus tendinopathy. However, we the duration of symptoms. As this was a randomized study, abandoned this arm of the study after very poor recruitment patients could continue with other treatment interventions for this condition (2 patients only) and have excluded these during the research. Patients were excluded if they were from the results. younger than 18 years, pregnant, or on anticoagulant therapy. Eligible participants read and signed a consent form before Outcome Measures being enrolled in the study. Duration of follow-up was a minimum of 6 months. Most patients completed their final Primary outcome measures were reduced pain and im- follow-up assessment at the 6-month period. However, we proved function. Pain was measured on the 100-mm visual allowed an extension for the 6-month follow-up assessment to analog scale (VAS).16 Pain and function with activities of be conducted until 12 months to reduce the dropout rate.