reswt in Heel Spur (Fasciitis Plantaris)

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1 Chapter 18.fm Page 193 Tuesday, November 21, :41 PM 18 reswt in Heel Spur (Fasciitis Plantaris) Gerald Hupt 1 Rupert Diesch, 2 Thomas Straub, 3 Emil Penninger, 3 Thomas Frölich, 4 Jakob Schöll, 5 Heinz Lohrer, 5 Dr. Theodor Senge 6 Introduction 17 The overall prevalence of fasciitis plantaris is about 15%. Lateral x-ray exams on caucasians revealed plantar and/or dorsal heel spurs in 15.7% whereby both legs were affected in 11%[32]. The incidence rises with age and is comparable for different continents such as Europe, Africa and America[2]. The primary symptom is pain, frequently associated with restrictions in range of motion (ROM)[3, 9, 14]. A multitude of conservative treatments have been described[30, 40, 41]. These include ultrasound [10, 37], lontopheresis [16] and low-energy laser [12] in addition to physical therapy, steroid injections and non-steroid antiphlogistics, however without evidence brought today of their efficacy. Operative therapy is recommended only following failure of conservative action[1]. 1 Urological clinic and policlinic - University of Cologne 2 Private practice, Friedrichshafen 3 Private practice, Dingolfing 4 Private practice, Stuttgart 5 Sportsmedicine Institute of Frankfurt 6 Urological clinic Uniersity of Bochum, Herne 193

2 Chapter 18.fm Page 194 Tuesday, November 21, :41 PM 194 EXTRACORPOREAL SHOCK WAVE THERAPY The introduction of extracorporeal shock waves for the treatment of urolithiasis has revolutionized renal calculi therapy. Additional applications focus on other calcull such as gallstones, pancreatic stones and salivary duct stones[28, 34, 35]. Since 1986 we have tested the effect of shock waves on the healing of wound and bone fractures in experimental models and were first to demonstrate the osteogenetic potential of shock waves[21-23]. This led to the therapy of pseudarthroses with shock waves. Finally, soft tissue diseases such as calcific tendonitis of the shoulder, epicondylitis lateralis and medialis and fasciitis plantaris have also been treated increasingly in recent years[7, 15, 31]. Apart from the conventional generation of shock waves, these can also be produced ballistically (Lithoclast) and were first used in urology (for endoscopic stone fragmentation). These processes are significantly more economical. Our own studies on soft tissue and bones of rabbits and monkeys showed that the results of treatment with ballistically produced radial shock waves coincided with those obtained following therapy with focused extracorporeal shock waves. Accordingly, one can state that the shock waves produced by either method are comparable in terms of their biological effect. This study examines the effect of radial shock waves on fasciitis plantaris. Materials and Methods All shock wave treatments were performed with the Swiss DolorClast (Figure 1), a modified device compared to the Swiss LithoClast, which is a unit for Figure 1. Therapy of the Fasciitis plantaris.

3 Chapter 18.fm Page 195 Tuesday, November 21, :41 PM reswt IN HEEL SPUR (FASCIITIS PLANTARIS) 195 Figure 2. Pain at night. the endoscopic treatment of calculi[27, 42]. The modifications were based on animal studies conducted on rabbits and rhesus monkeys[19]. In plantar heel pain, the tip of the applicator was positioned at the point where the greatest pain was reported via patient feedback (Figure 2). Shock waves were delivered via a customary medium (ultrasound gel). Patients One hundred and three consecutive patients with chronic fasciitis plantaris were examined as part of a multicentric, prospective, randomized and placebocontrolled study. Patients were enrolled if they reported a pain history of at least 6 months with at least 2 different failed attempts at a conservative treatment indicating the need for surgery. Exclusion criteria were defined as poor health condition (Karnofsky index < 70), a specific intervention within the last two weeks, pregnancy, disturbance in coagulation, tumors in the area to be treated and systemic diseases which could be interpreted as possible causes of pain in differential diagnostics (e.g. collagenosis, rheumatic diseases). Patients were randomized at a 1:1 ratio into a verum or sham group. While both groups obtained identical treatments, the test set-up was modified in the control group so that no shock waves would be transmitted. Up to 3 treatments were conducted without local anesthesia. Local anesthesia was administered only in exceptional cases when pain was no longer tolerable. Follow-up exams were conducted after 1, 4, 12 and 52 weeks.

4 Chapter 18.fm Page 196 Tuesday, November 21, :41 PM 196 EXTRACORPOREAL SHOCK WAVE THERAPY Total Verum group Control group Age (years) 50.4 ± ± ± 12.3 Female Male Right position Left position Pain duration (months) 24.0 ± ± ± 28.1 Table 1. Demographic data. If pain persisted after 4 weeks in patients from the control group, blinding was terminated and admission to the treatment group was authorized. Questionnaires were filled out by the treating orthopedist or surgeon and forwarded anonymously to the study center for statistical evaluation (SPSS). Results One hundred and three patients were admitted to the study. Fifty five patients were randomized into the verum group, 48 into the control group. Demographic data (Table 1) as well as symptoms and initial findings (Table 2) show homogeneity at baseline. Treatments were performed at an initial pressure of 4 bar with 2000 shock waves. Local anesthesia was required for 5 patients (9%) in the verum group and 3 patients (6%) in the control group. Local symptoms could be observed immediately following treatment (Table 3), but they disappeared after 1 week. Eighty-four patients were examined up to 52 weeks after the last reswt. Night pain, pain at rest and walking improved significantly in the treatment group compared to placebo (Figures 3-5). In fact, an increasing improvement throughout the entire follow-up period could be observed. In the control group no significant change between initial findings and follow-up could be found. Patients who dropped out of the control group 4 weeks after reswt due to persistent pain received an unblinded active treatment. They finally achieved results similar to the primary treatment group.

5 Chapter 18.fm Page 197 Tuesday, November 21, :41 PM reswt IN HEEL SPUR (FASCIITIS PLANTARIS) 197 Total Verum group Control group Night pain Restriction in daily life Restriction in sports Restriction in occupation Maximum walking time Restricted Not restricted Start-up pain Redness Overheating Swelling Scars Injection sites Skewfoot Splayfoot Flatfoot Pes equinocavus Table 2. Pathology and findings giving as percent (%). Total Verum group Control group Irritation Petechial bleedings Hematoma Swelling Pain Table 3. Postoperative adverse events (%).

6 Chapter 18.fm Page 198 Tuesday, November 21, :41 PM 198 EXTRACORPOREAL SHOCK WAVE THERAPY Figure 3. Rest pain. Limitations in walking time and daily activities in the verum group were persistent in 36% and 34% respectively. Limitations in sports and profession, were persistent in 52% and 50%, even though the extent of the limitation had decreased significantly. Comparative values for the control group are above 70%. The majority of patients would repeat the treatment after 1 week. This remained unchanged in the verum group. In the control group this value drops down after 4 weeks and once again after 12 weeks (Figure 5). This observation Figure 4. Walking pain.

7 Chapter 18.fm Page 199 Tuesday, November 21, :41 PM reswt IN HEEL SPUR (FASCIITIS PLANTARIS) 199 Figure 5. Acceptance of reapplication. correlates with the patients satisfaction. After 12 weeks, over 90% of patients report an improvement and more than 60% are even completely satisfied. In the control group, this is documented as 10% (Figure 6). No clinically relevant side effects were found, but minor petechial bleeding and swelling were reported. Discussion In the past 30 years, the effects of many physical factors on the healing processes of bone and soft tissue have been studied. With the consideration of Figure 6. Patient satisfaction.

8 Chapter 18.fm Page 200 Tuesday, November 21, :41 PM 200 EXTRACORPOREAL SHOCK WAVE THERAPY extracorporeal shock waves for the treatment of urolithiasis, a new physical medium was introduced to medicine[4, 5]. Shock waves are able to generate effects without any surgery. These shock wave were used in urolithiasis. As of 1985 gall stones and pancreatic and salivary duct calculi were treated with shock waves also[28, 34, 35]. Common to all these therapies is a fragmentation of the calculi by the shock waves. Shock waves were used for the first time in 1986 for the purpose of stimulating healing processes rather than fragmenting stones. Low energetic shock waves were known to stimulate wound healing but high energetic shock waves did not. These findings were observed in superficial skin wounds in pigs[20]. In addition, shock waves were shown to have an osteogenetic effect, which led to the use of shock waves in the treatment of pseudarthrosis[11, 15, 17, 18, 22, 24, 25, 36, 38, 39]. The positive effects on wound healing were no longer used until recent studies have shown again these effects. The wound healing effect is discussed further within the chapter written by Wolfgang Schaden and Richard Thiele. In the case of fasciitis plantaris, for a long time almost no multicentric, controlled studies have examined conservative or operative processes. In the meantime, several excellent prospective randomized placebo-controlled studies on the effect of focused ESWT have been published, some with partially contradictory results[43, 44, 45]. Therefore, an evaluation of the efficacy of focused ESWT is not conclusively possible but it is certain that a conservative therapy of ESWT is indicated prior to surgery. The recent reviews have shown the evidence of shock waves on chronic plantar heel pain. This study reports for the first time on the effect of radial ESWT (reswt) for the treatment of heel spur. The patients enrolled in this trial had at least two unsuccessful conservative therapies and the pain duration was longer than 6 months. This corresponds to a negative selection. The subjective success rates of conventional extracorporeal shock wave therapy are shown as 50 to 75% painfree or significant pain reduction[6, 8, 29, 33]. Radial shock wave therapy obtains comparable success rates. The well known placebo effect, which is device associated, was controlled by a sham reswt group. The essential difference and advantage compared to conventional focused shock wave therapy is: reswt is easy to administer, no imaging is required, no local anesthesics are required and the cost is significantly reduced. In case of failed reswt, surgical options remain possible.

9 Chapter 18.fm Page 201 Tuesday, November 21, :41 PM reswt IN HEEL SPUR (FASCIITIS PLANTARIS) 201 The side effects of radial therapy are similar to those of focused ESWT such as transitory pain, petechial bleeding or subcutaneous hematomata in up to 4% of the patients[26]. However, local skin symptoms are clearly more frequent in radial therapy which is easy to explain because of the high energy close to the tip of the applicator. After 1 week, no more side effects were found and no neurological disorders occurred. Local irritation therefore does not appear to reach clinical relevance. The use of shock waves in orthopedics remains controversial and continues to be documented by insufficient studies[13]. A multitude of shock wave studies have been published but only few prospective randomized controlled studies are available. Nevertheless, this therapy for fasciitis plantaris has been found to be effective and is not to be classified as lifestyle therapy. The high recommendation by patients and physicians supports the clinical evidence that ESWT is effective, much more than any surgical or injection technique. The radial shock wave therapy examined in our study appears to be clinically effective without side effects. Therefore it is reasonable to use the reswt for the treatment of chronic fasciitis. In addition, reswt provides for a very economical treatment when compared to conventional shock wave processes. Literature 1. Anderson, R.B., M.D. Foster: Operative treatment of subcalcaneal pain. Foote Ankle (US) 9(1989) Banadda, B.M., O. Gona, D.M. Ndlovu, R. Vaz: Calcaneal spurs in a black African population. Foot Ankle 13(1992) Baxter, D.E., C.M. Thigpen: Heel pain: operative results. Foot Ankle 5(1984) Chaussy, C., Extracorporeal shock wave lithotripsy. 1982, Basel: Karger. 5. Chaussy, C., F. Eisenberger, K. Wanner, F. Forssmann, W. Hepp, E. Schmiedt, W. Brendel: The use of shock waves for the destruction of renal calculi without direct contact. Urol. Res. 4(1976) Dahmen, G.P., R. Franke, V. Gonchars, K. Poppe, S. Lentrodt, S. Lichtenberger, S. Jost, J. Montigel, V.C. Nam, G. Dahmen: Die Behandlung knochennaher Weichteilschmerzen mit Extrakorporaler Stosswellentherapie (ESWT), Indikation, Technik und bisherige Ergebnisse. In: Chaussy, C., F. Eisenberger, D. JochamD. Wilbert (Hrsg.): Die Stosswelle - Forschung und Klinik, Attempto Verlag, Tübingen (1995)

10 Chapter 18.fm Page 202 Tuesday, November 21, :41 PM 202 EXTRACORPOREAL SHOCK WAVE THERAPY 7. Dahmen, G.P., L. Meiss, V.C. Nam, B. Skruodies: Extrakorporale Stosswellentherapie (ESWT) im knochennahen Weichteilbereich an der Schulter. Extracta Orthopaedica 11(1992) Diesch, R., G. Haupt: Extracorporeal shock waves in the treatment of pseudarthrosis, calcific tendinitis of the shoulder and calcaneal spur. In: Siebert, W.M. Buch (Hrsg.): Springer Verlag, Berlin Heidelberg New York (1997) DuVries, H.L.: Heel spur (calcaneal spur). A.M.A. Arch. Surg. 74(1957) Ebenbichler, G., K.L. Resch: Kritische Überprüfung des therapeutischen Ultraschalls. Wien. Med. Wochenschr. 144(1994) Ekkernkamp, A., A. Bosse, G. Haupt, A. Pommer: Der Einfluß der extrakorporalen Stosswellen auf die standardisierte Tibiafraktur am Schaf. In: Ittel, T., G. SieberthH. Matthiass (Hrsg.): Aktuelle Aspekte der Osteologie, Springer, Berlin Heidelberg New York (1992) Ernst, E., V. Fialka: Low-dose Lasertherapie: eine kritische Prüfung der klinischen Wirksamkeit. Schweiz. Med. Wochenschr. 123(1993) Fritze, J.: Extrakorporale Stosswellentherapie (ESWT) in orthopädischer Indikation: Eine ausgewählte Übersicht. Versicherungsmedizin 50(5) (1998) Furey, J.G.: Plantar fasciitis: the painful heel syndrome. J. Bone Joint Surg. 75- A(1975) Graff, J., Die Wirkung hochenergetischer Stosswellen auf Knochen und Weichteilgewebe. 1989, Bochum: Habilitationsschrift, Ruhr-Universität Bochum. 16. Grossi, E., G.C. Monza, S. Pollavini, L. Bona: NSAID ionisation inthe management of soft tissue rheumatism: role played by the drug, electrical stimulation and suggestion. Clin. Exp. Rheumatol. 4 (1986) Haist, J.: Die Osteorestauration via Stosswellenanwendung. Eine neue Möglichkeit zur Therapie der gestörten knöchernen Konsolidierung. In: Chaussy, C., F. Eisenberger, D. JochamD. Wilbert (Hrsg.): Die Stosswelle - Forschung und Klinik, Attempto Verlag, Tübingen (1995) Haist, J., D. Steeger, U. Witzsch, R.A. Bürger, U. Haist: The extracorporeal shockwave therapy in the treatment of disturbed bone union. 7th Int. Conference on Biomedical Engineering, Singapore (1992) Haupt, G., Behandlung von Harnsteinen, Knochen und Weichgewebe mit ballistischer Energie: Leistungsfähigkeit und Systemerweiterung einer neuen minimal-invasiven Therapietechnik. 1997: Ruhr-Universität Bochum. 20. Haupt, G., M. Chvapil: Effect of shock waves on the healing of partial-thickness wounds in piglets. J. Surg. Res. 49(1990) Haupt, G., A. Ekkernkamp, M. Chvapil, A. Haupt, B. Gerety: Der Einfluß extrakorporaler Stosswellen auf die Knochenbruchheilung. Hefte zur Unfallheilkunde 220(1991) Haupt, G., A. Haupt, A. Ekkernkamp, B. Gerety, M. Chvapil: Influence of shock waves on fracture healing. Urology 39(1992) Haupt, G., A. Haupt, B. Gerety, M. Chvapil: Enhancement of fracture healing with extracorporeal shock waves. J. Urol. 143(1990) 230A 24. Haupt, G., A. Haupt, T. Senge: Die Behandlung von Knochen mit extrakorporalen Stosswellen - Entwicklung einer neuen Therapie. In: Chaussy, C., F. Eisenberger, D. JochamD. Wilbert (Hrsg.): Stosswellenlithotripse, Aspekte und Prognosen, Attempto Verlag, Tübingen (1993) Haupt, G., P. Katzmeier: Anwendung der hochenergetischen extrakorporalen Stosswellentherapie bei Pseudarthrosen, Calcific tendinitis der Schulter und Ansatztendinosen (Fersensporn, Epicondylitis). In: Chaussy, C., F. Eisenberger, D.

11 Chapter 18.fm Page 203 Tuesday, November 21, :41 PM reswt IN HEEL SPUR (FASCIITIS PLANTARIS) 203 JochamD. Wilbert (Hrsg.): Die Stosswelle - Forschung und Klinik, Attempto Verlag, Tübingen (1995) Haupt, G., A. Menne, M. Schulz: Medizinisches Instrument zum Erzeugen und Weiterleiten von extrakorporalen nicht fokussierten Druckwellen auf biologisches Gewebe. Patentanmeldung (1997) 27. Haupt, G., R. Olschewski, S. Hartung, T. Senge: Comparison of laser and ballistic systems by in vitro lithotripsy with a standardized stone model. J. Endourol. 7(1993) S Iro, H., H. Schneider, C. Födra, G. Waitz, N. Nitsche, H.H. Heinritz, J. Benninger, C. Ell: Shockwave lithotripsy of salivary duct stones. Lancet 339(1992) Krischek, O., J.-D. Rompe, B. Herbsthofer, B. Nafe: Symptomatische niedrigenergetische Stosswellentherapie bei Fersenschmerzen und radiologisch nachweisbarem plantaren Fersensporn. Z. Orthop. 136(1998) Labelle, H., R. Guibert, N. Newman, M. Fallaha, C.-H. Rivard: Lack of scientific evidence for the treatment of lateral epicondylitis of the elbow. J. Bone. Joint. Surg. 74-B(1992) Loew, M., W. Jurgowski: Erste Erfahrungen mit der Extrakorporalen Stosswellen- Lithotripsie (ESWL) ind der Behandlung der Tendinosis calcarea der Schulter. Z. Orthop. 131(1993) Riepert, T., T. Drechsler, R. Urban, H. Schild, R. Matern: Häufigkeit, Altersabhängigkeit und Geschlechtsverteilung des Fersensporns. Analyse der Röntgenmorphologie bei 1027 Patienten der mitteleuropäischen Population. Rofo Fortschr. Geb. Röntgenstr. Neuen Bildgeb. Verfahr. 162(1995) Rompe, J.D., K. Küllmer, P. Eysel, H.M. Riehle, R. Bürger, B. Nafe: Niedrigenergetische extrakorporale Stosswellentherapie ESWT beim plantaren Fersensporn. Orthop. Praxis 32(1996) Sauerbruch, T., M. Delius, G. Paumgartner, J. Holl, O. Wess, W. Weber, W. Hepp, W. Brendel: Fragmentation of gallstones by extracorporeal shock waves. New Engl. J. Med. 314(1986) Sauerbruch, T., J. Holl, M. Sackmann, R. Werner, R. Wotzka, G. Paumgartner: Disintegration of a pancreatic duct stone with extracorporeal shock waves in a patient with chronic pancreatitis. Endoscopy 19(1987) Schleberger, R.: Anwendung der extrakorporalen Stosswelle am Stütz- und Bewegungsapparat im mittelenergetischen Bereich. In: Chaussy, C., F. Eisenberger, D. JochamD. Wilbert (Hrsg.): Die Stosswelle - Forschung und Klinik, Attempto Verlag, Tübingen (1995) Stratford, P.W., D.R. Levy, S. Gauldie, D. Miseferi, K. Levy: The evaluation of phonophoresis and friction message as treatments for extensor carpi radialis tendinitis: a randomized controlled trial. Physiotherapy Canada 41(1989) Sukul, K., E.J. Johannes, E. Pierik, G. van Eijck, M. Kristelijn: The effect of high energy shock waves focused on cortical bone: an in vitro study. J. Surg. Res. 54(1993) Valchanou, V.D., P. Michailov: High energy shock waves in the treatment of delayed and nonunion fractures. Internat. Orthopaedics (SICOT) 15(1991) Verhaar, J., G. Walenkamp, A. Kester, H. van Mameren, T. van der Linden: Lateral extensor release for tennis elbow. A prospective long-term follow-up study. J. Bone Joint Surg. 75-A(1993) Wittenberg, R., S. Schaal, G. Muhr: Surgical treatment of persistent elbow epicondylitis. Clin. Orthop. 278(1992) Zhong, P., G.M. Preminger: In vitro comparison of different modes of intracorporeal shock wave lithotripsy. J. Urol. 153(1995) S47

12 Chapter 18.fm Page 204 Tuesday, November 21, :41 PM 204 EXTRACORPOREAL SHOCK WAVE THERAPY 43. Rompe JD, et al. Shock wave application for chronic plantar fasciitis in running athletes a prospective, randomized, placebo- controlled trial. Am J Sports Med 2003; 31: Buchbinder R, Ptasznik R, Gordon J, Buchanan J, Prabaharan V, Forbes A: Ultrasound-guided extracorporeal shock wave therapy for plantar fasciitis. A randomized controlled trial. JAMA 288: , Haake M, Buch M, Schoellner C, Goebel F: Extracorporeal shock wave therapy for plantar fasciitis: randomised controlled multicentre trial. British Medical Journal 327: 1-5, 2003

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