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Extracorporeal shock wave therapy versus other therapeutic methods for chronic plantar fasciitis
G Model FAS 1237 No. of Pages 6
Foot and Ankle Surgery xxx (2018) xxx–xxx
Contents lists available at ScienceDirect
Foot and Ankle Surgery journal homepage: www.elsevier.com/locate/fas
Extracorporeal shock wave therapy versus other therapeutic methods for chronic plantar fasciitis Kai Sun, Haiyu Zhou, Wenxue Jiang* Tianjin First Center Hospital, Fukang Road No. 24, Nankai District, Tianjin, 300192, China
A R T I C L E I N F O
A B S T R A C T
Article history: Received 10 August 2018 Received in revised form 24 October 2018 Accepted 3 November 2018 Available online xxx
Background: To conduct a meta-analysis comparing the efficacy of general ESWT with that of other therapies and to assess its effectiveness in chronic plantar fasciitis. Methods: A literature search was performed in PubMed, Embase, Web of Science and the Cochrane Library for information from the earliest date of data collection to March 2018. Studies comparing the benefits and risks of extracorporeal shock wave therapy with those of other therapies for chronic plantar fasciitis were included. Statistical heterogeneity was quantitativelyevaluated bya X2 test with the significance set as P < 0.10 or I2 > 50%. Results: Thirteen trials consisting of 1,185 patients were included (637 patients were treated with ESWT; 548 patients, with OT). The results showed that patients treated with ESWT had increased success or improvement rates, an increased modified Roles & Maudsley (RM) score, a reduction of pain scales, reduced return to work time, and fewer complications than patients treated with other therapy methods (P < 0.1). Conclusions: Compared with patients who received other therapies for chronic plantar fasciitis, patients treated with ESWT responded better, had less complications and showed a clear difference in efficacy between ESWT and other therapy in chronic plantar fasciitis. Level of Evidence: Level IV, therapeutic study. © 2018 European Foot and Ankle Society. Published by Elsevier Ltd. All rights reserved.
Keywords: Extracorporeal shock wave therapy Other therapeutic Effectiveness Complications Chronic plantar fasciitis
1. Introduction Heel pain is a general term for the pain of the heel. It refers to a variety of chronic diseases, including plantar fasciitis on the internal and lateral aspect of the heel. Plantar fasciitis is a common cause of heel pain [1]. It occurs mostly among people aged 40–70 years old. The ratio of men to women is approximately 2:1. The aetiology and pathogenesis of heel pain are various and complex. Clinically, it is mainly caused by plantar aponeurosis, calcaneal fat pads, calcaneus bursitis, calcaneus hypertension, or lateral plantar nerve entrapment [2]. The cause of degeneration is repetitive microtears in the plantar fascia that overcome the body’s capacity to repair itself [2]. In general, plantar fasciitis is a self-limiting disease. Unfortunately, the time until resolution is often 6–18 months, which can lead to frustration for patients and physicians [3,4].
Abbreviations: ESWT, extracorporeal shock wave therapy; OT, other therapy; RM, roles & maudsley; RCT, randomized controlled trials. * Corresponding author. E-mail addresses: [email protected] (K. Sun), [email protected] (H. Zhou), [email protected] (W. Jiang).
Conservative lines of treatment include non-steroidal antiinflammatory drugs, heel pads or orthotics, physical therapy, stretching exercises, and corticosteroid injections. However, extracorporeal shockwave therapy is regarded as the mainstay of treatment and provides substantial relief to approximately 80% of patients [5]. Extracorporeal shock waves are focussed, single pressure pulses of microsecond duration and represent one of the most effective approaches to the treatment of chronic plantar fasciitis. Extracorporeal shock wave therapy (ESWT) has been recently used in the treatment of a number of musculoskeletal conditions, including insertional disorders such as plantar fasciitis [6,7]. Extracorporeal shock wave therapy (ESWT) has been used for the treatment of recalcitrant painful heel syndrome as an alternative to surgery, allowing fast recovery times without the necessity of reduced weightbearing or immobilization. The rationale for such an approach is the stimulation of soft tissue healing, reduction of calcification, inhibition of pain receptors, or denervation to achieve pain relief [8,9], although the true effects have not been established, and doses and regimes can vary. The effectiveness of ESWT in plantar fasciitis however, is controversial The purpose of this metanalysis therefore, was to compare the results of ESWT and other therapeutic modalities in the treatment of chronic plantar fasciitis.
https://doi.org/10.1016/j.fas.2018.11.002 1268-7731/© 2018 European Foot and Ankle Society. Published by Elsevier Ltd. All rights reserved.
Please cite this article in press as: K. Sun, et al., Extracorporeal shock wave therapy versus other therapeutic methods for chronic plantar fasciitis, Foot Ankle Surg (2018), https://doi.org/10.1016/j.fas.2018.11.002
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K. Sun et al. / Foot and Ankle Surgery xxx (2018) xxx–xxx
2. Materials and methods 2.1. Literature and search strategy Two different reviewers independently searched PubMed, Embase, Web of Science and the Cochrane Library for information from the inception of the databases to March 2018. The following related terms were searched: extracorporeal shock wave therapy; focused extracorporeal shock wave therapy; radial extracorporeal shock wave therapy; plantar fasciitis; plantar fasciopathy; chronic plantar fasciitis; heel pain; other therapeutic; placebo; and RCTs. The searching strategy was constructed by combining the above terms with “AND” or “OR”. The publication language was limited to English. We also screened the reference lists of retrieved articles so that relevant studies were not missed. 2.2. Study selection criteria Two different reviewers independently assessed the retrieved articles to determine whether they met the inclusion criteria. In
the case of disagreements, a third reviewer was involved in the discussion until a consensus was reached. Studies that met the following criteria were included in the current meta-analysis: investigations of patients suffering from heel pain and diagnosed with chronic plantar fasciitis; studies involving the comparison of ESWT without anaesthesia and sham therapy as a control; cohort studies; and randomized controlled trials (RCTs). Exclusion criteria included: (1) case-control studies, animal studies, cadaver studies, single case reports, comments, letters, editorials, protocols, guidelines, publications based on surgical registries, and review papers; (2) patients with the following characteristics: rheumatic or other systemic inflammatory disease, inflammatory disorders of the upper and/or lower ankle, collagenosis, diabetes mellitus or other metabolic diseases, tendon ruptures in the treatment area, neurological or vascular insufficiencies, nerve entrapment syndrome, hyperthyroidism, active malignant disease with or without metastases, Paget’ s disease, calcaneal fat pad atrophy, osteomyelitis or active infection or history of chronic infection in the treatment area, previous surgery for painful heel, unsuccessful prior ESWT, or bilateral heel pain.
Fig. 1. Flow chart illustrating the literature search. Table 1 Characteristics of the included studies. References
No. Patients ESWT
[33] [18] [32] [30] [23] [19] [22] [17] [24] [34] [31] [21] [16]
50 125 15 20 25 16 125 20 112 53 12 46 15
Gender (male:female)
Mean age (years)
OT
ESWT
OT
ESWT
OT
32 121 15 17 25 9 118 20 56 52 25 42 15
32:18 40:84 4:11 13:7 7:18 7:9 38:87 11:9 36:76 18:35 6:6 20:26 10:5
20:12 33:88 2:13 8:9 11:14 4:5 39:79 4:16 21:35 25:27 5:20 17:25 9:6
57.2 50.0 45.6 46.0 56.6 51.9 52.4 53.9 50.8 51.1 46.9 51.7 47.0
59.2 47.4 45.0 42.0 49.1 51.7 52.0 58.9 52.1 48.8 48.3 52.5 51.0
Mean duration of pain (range) (month)
Follow-up (months)
>6 >6 >12 >16 >6 >21 >25 >11 >31 >31 >31 >16 >16
3 3 6 11 6 6 6 3 6 6 6 6 3
ESWT: Extracorporeal Shockwave Therapy. OT: Other Therapeutic.
Please cite this article in press as: K. Sun, et al., Extracorporeal shock wave therapy versus other therapeutic methods for chronic plantar fasciitis, Foot Ankle Surg (2018), https://doi.org/10.1016/j.fas.2018.11.002
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Fig. 2. Risk of bias graph.
2.3. Data extraction and quality assessment Two different reviewers independently performed the data extraction and methodological quality assessment. Data extracted from the included studies consisted of authors, publication date, study design, number of patients, treatment approach, follow-up duration and outcome data for both extracorporeal shock wave therapy and other therapeutic groups. The outcome measures included success or improvement rates, the modified Roles & Maudsley (RM) score, reduction of pain scales, return to work time, and complications. The methodological quality of a study was evaluated in six domains, including sequence generation, allocation concealment, participants’ blinding, assessors’ blinding, incomplete data, selective reporting and other bias. Each included study could have an unclear risk, low risk or high risk of bias for each domain based on Cochrane’s Handbook 5.1.0. 2.4. Statistical analysis Statistical analyses were performed using Review Manager Software 5.3. For dichotomous outcomes, the odds ratio (OR) with a 95% CI (confidence interval) was calculated to estimate a pooled average difference between ESWT with OT. The WMD (weighted mean differences) and 95% CI were calculated for continuous outcomes. Statistical heterogeneity was quantitatively evaluated by a Chi-square test with the significance set as P < 0.10 or I2 > 50%. The data were presented in the form of Forest plots. Publication bias was assessed by a funnel plot. 3. Results 3.1. Literature search
Fig. 3. Risk of bias summary (+ indicates a low risk of bias, bias, ? indicates unclear or unknown risk of bias).
indicates a high risk of
The retrieval strategy is displayed in Fig. 1. In total, 330 potentially eligible citations were searched online. After removing duplicates, browsing titles and abstracts and reviewing the fulltext, 13 papers met the inclusion criteria. Among all the participants of the 13 papers, the outcomes for a total of 1185 patients were described, of which 637 patients were treated with ESWT and 548 patients with OT. The detailed characteristics of the studies are listed in Table 1. No other apparent bias was found among the included studies. Figs. 2 and 3 show the risk of bias summary.
Please cite this article in press as: K. Sun, et al., Extracorporeal shock wave therapy versus other therapeutic methods for chronic plantar fasciitis, Foot Ankle Surg (2018), https://doi.org/10.1016/j.fas.2018.11.002
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Fig. 4. Forest plot of comparison: success or improvement rates (ESWT = Extracorporeal Shock Wave Therapy; OT = Other Therapy; CI confidence interval, df degrees of freedom).
Fig. 5. Forest plot of comparison: Reduction of pain scales (ESWT = Extracorporeal Shock Wave Therapy; OT = Other Therapy; CI confidence interval, df degrees of freedom).
Fig. 6. Forest plot of comparison: RM scores (ESWT = Extracorporeal Shock Wave Therapy; OT = Other Therapy; CI confidence interval, df degrees of freedom).
3.2. Results of the meta-analysis Thirteen trials reported success or improvement rates. The pooled results showed that ESWT was related to a greater increase in success or improvement rates compared with OT, with an OR = 2.64; 95% CI, 2.06–3.39; P < 0.01, without significant heterogeneity (I2 = 35%) (Fig. 4). Eleven trials reported reduction of pain scales. The results showed that ESWT was related to a greater increase in the reduction of pain scales compared with OT, with SMD = 0.43; 95% CI, 0.31–0.55; P < 0.01, without significant heterogeneity (I2 = 28%) (Fig. 5). Five trials reported the modified Roles & Maudsley (RM) score. The results showed that ESWT was related to a greater increase in RM scores, with SMD = 0.39; 95% CI, 0.57 to 0.20; P < 0.01, without significant heterogeneity (I2 = 12%) (Fig. 6). Four trials reported return to work time. The results showed that OT was related to a greater increase in return to work time,
with SMD = 2.54; 95% CI, 2.89 to 2.20; P < 0.01, without significant heterogeneity (I2 = 0%) (Fig. 7). Eleven trials reported complications. The results showed that OT was related to a greater increase in complications, with OR = 0.50; 95% CI, 0.29–0.86; P < 0.01, without significant heterogeneity (I2 = 0%) (Fig. 8). 4. Discussion We conclude that other therapy, such as placebo treatment, had a negative influence on the outcome of patients treated with chronic plantar fasciitis, with more short-term complications and poorer long-term outcome compared with extracorporeal shock wave patients. The aim of our systematic review of the literature was to show whether other therapy, such as placebo treatment, leads to a worse outcome following chronic plantar fasciitis. ESWT therapy for chronic plantar fasciitis might be more effective than
Please cite this article in press as: K. Sun, et al., Extracorporeal shock wave therapy versus other therapeutic methods for chronic plantar fasciitis, Foot Ankle Surg (2018), https://doi.org/10.1016/j.fas.2018.11.002
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Fig. 7. Forest plot of comparison: return to work time (ESWT = Extracorporeal Shock Wave Therapy; OT = Other Therapy; CI confidence interval, df degrees of freedom).
Fig. 8. Forest plot of comparison: Complications (ESWT = Extracorporeal Shock Wave Therapy;OT = Other Therapy; CI confidence interval, df degrees of freedom).
other therapies and offer a safe alternative to treat chronic plantar fasciitis. Heel pain is a common symptom [10]. When standing and walking, the symptoms are worse. The aetiology and mechanisms are not clear, but studies have found that this disease is closely related to strain and bone degeneration [11–14]. The treatment of heel pain is mainly analgesic. The current treatment methods include two categories: conservative treatment and surgical treatment. Conservative treatment is local physical therapy, local blocking, activating blood circulation and so on [15–20]. Surgical treatment can be considered when conservative treatment is ineffective. The operation is selected according to the cause of the disease. Lateral nerve transaction can be useful for improving symptoms. For calcaneal spurs, spur resection is used, but sometimes bone spurs grow again or relapse [21–24]. Extracorporeal shock waves can propagate in three dimensions, and the propagation speed increases with pressure. It can pass through body fluids and tissues to reach the affected area [25]. In 1980, extracorporeal shock wave therapy was first used [26–28]. After the success of shock wave treatment of renal calculi, the scope of shock wave treatment gradually expanded from lithotripsy and treatment of fracture non-union to chronic pain treatment [29,30]. A prospective study of extracorporeal shock wave therapy for heel pain was carried out. Three months later, the therapeutic composition was 56% higher than that of the control group, and heel pain became the first orthopaedic disease to be treated by shock wave with FDA approval [31,32]. High intensity shock waves can produce super-stimulation of the nerve and tissue, release substances that inhibit pain, stimulate the pain nerve receptor, reduce nerve sensitivity and nerve conduction, and can also change nociceptors [33]. The frequency of pain acceptance changes the composition of the chemical medium around the nociceptor and inhibits the transmission of pain information and thereby alleviates pain [34].
Due to the energy of the extracorporeal shock waves, the patient may feel needle-like sensations. This should be explained to the patient before treatment. If the pain is aggravated, the patient should be revisited over time. This study has some limitations. It is difficult to design highquality studies regarding the effect of the ESWT on the outcomes of chronic plantar fasciitis, because participants cannot be randomly assigned to exposure groups, and blinding is only partly possible. Obtaining Level-I evidence for the impact of ESWT on the outcome of chronic plantar fasciitis is difficult. Because of partial blinding, a high-quality study cannot be performed. We chose to include all comparative studies in this systematic review to represent the best evidence available at present. Differentiation between retrospective and prospective trials can be difficult because many authors present a study with prospective data collection and retrospective analysis of the data as being prospective in design. Scoring of the methodology, however, showed that the studies included in this review were comparable and that pooling them was therefore justifiable. 5. Conclusion This is a meta-analysis comparing the efficacy of ESWT with other therapy in chronic plantar fasciitis. The most important finding was the clear difference in the efficacy between ESWT and other therapy for chronic plantar fasciitis. The patients treated with ESWT showed better success or improvement rates in the modified Roles & Maudsley (RM) score, reduction in pain scales and return to work time and less complications than the other therapeutic methods.It also appears reasonable to conclude that the patient treated with other therapy at least benefits from a thorough analysis of existing complications and improvement of his or her medical condition. Further higher-quality, multicentre,
Please cite this article in press as: K. Sun, et al., Extracorporeal shock wave therapy versus other therapeutic methods for chronic plantar fasciitis, Foot Ankle Surg (2018), https://doi.org/10.1016/j.fas.2018.11.002
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prospective studies with good design, a large number of participants and long-term follow-up RCTs are necessary to confirm these results. Competing interests The authors declare that they have no competing interests. Funding No. Ethical review committee statement The study was approved by the institutional review board of Tianjin First Center Hospital; Tianjin, China. A Statement of the location The work was performed in Tianjin First Center Hospital. Authors’ contributions Kai Sun designed the study protocol, participated in the data analysis, and drafted the manuscript. Haiyu Zhou and Wenxue Jiang participated in the analysis and revision of the manuscript. Acknowledgements The authors would like to thank Tianjin First Center Hospital and Tianjin First Center Hospital for providing the database. References [1] Rompe JD. Plantar fasciopathy. Sports Med Arthrosc 2009;17:100–4. [2] Rompe JD, Furia J, Weil L, Maffulli N. Shock wave therapy for chronic plantar fasciopathy. Br Med Bull 2007;81–82:183–208. [3] Lim AT, How CH, Tan B. Management of plantar fasciitis in the outpatient setting. Singapore Med J 2016;57:168–70. [4] Mardani-Kivi M, Karimi Mobarakeh M, Hassanzadeh Z, Mirbolook A, Asadi K, Ettehad H, et al. Treatment outcomes of corticosteroid injection and extracorporeal shock wave therapy as two primary therapeutic methods for acute plantar fasciitis: a prospective randomized clinical trial. J Foot Ankle Surg 2015;54:1047–52. [5] Roca B, Mendoza MA, Roca M. Comparison of extracorporeal shock wave therapy with botulinum toxin type A in the treatment of plantar fasciitis. Disabil Rehabil 2016;38:2114–21. [6] Rompe JD, Cacchio A, Weil L, Furia JP, Haist J, Reiners V, et al. Plantar fasciaspecific stretching versus radial shock-wave therapy as initial treatment of plantar fasciopathy. J Bone Joint Surg Am 2010;92:2514–22. [7] Rompe JD, Furia J, Cacchio A, Schmitz Christoph, Maffullie Nicola. Radial shock wave treatment alone is less efficient than radial shock wave treatment combined with tissuespecific plantar fascia-stretching in patients with chronic plantar heel pain. Int J Surg 2015;24:135–42. [8] Lee SJ, Kang JH, Kim JY, Kim JH, Yoon SR, Jung KI. Dose-related effect of extracorporeal shock wave therapy for plantar fasciitis. Ann Rehabil Med 2013;37:379–88. [9] Park JW, Yoon K, Chun KS, Lee JY. Long-term outcome of low-energy extracorporeal shock wave therapy for plantar fasciitis: comparative analysis according to ultrasonographic findings. Ann Rehabil Med 2014;38:534–40. [10] Rompe JD, Schoellner C, Nafe B. Evaluation of low-energy extracorporeal shock-wave application for treatment of chronic plantar fasciitis. J Bone Joint Surg Am 2002;84-A:335–41. [11] Vahdatpour B, Sajadieh S, Bateni V, Karami Mehdi, Sajjadieh Hamidreza. Extracorporeal shock wave therapy in patients with plantar fasciitis. A randomized, placebocontrolled trial with ultrasonographic and subjective outcome assessments. J Res Med Sci 2012;17:834–8. [12] Yan W, Sun S, Li X. Therapeutic effect of extracorporeal shock wave combined with orthopaedic insole on plantar fasciitis. Zhong Nan Da Xue Bao Yi Xue Ban 2014;39:1326–30.
[13] Moghtaderi A, Khosrawi S, Dehghan F. Extracorporeal shock wave therapy of gastroc-soleus trigger points in patients with plantar fasciitis: a randomized, placebo-controlled trial. Adv Biomed Res 2014;3:99. [14] Rompe JD, Meurer A, Nafe B, Hofmann Alexander, Gerdesmeyer Ludger. Repetitive low-energy shock wave application without local anesthesia is more efficient than repetitive lowenergy shock wave application with local anesthesia in the treatment of chronic plantar fasciitis. J Orthop Res 2005;23:931–41. [15] Kudo P, Dainty K, Clarfield M, Coughlin Larry, Lavoie Pauline, Lebrun Constance. Randomized, placebocontrolled, double-blind clinical trial evaluating the treatment of plantar fasciitis with an extracoporeal shockwave therapy (ESWT) device: a North American confirmatory study. J Orthop Res 2006;24:115–23. [16] Rompe JD, Hopf C, Nafe B, Bürger R. Low-energy extracorporeal shock wave therapy for painful heel: a prospective controlled single-blind study. Arch Orthop Trauma Surg 1996;115:75–9. [17] Gollwitzer H, Diehl P, von Korff A, Rahlfs VW, Gerdesmeyer L. Extracorporeal shock wave therapy for chronic painful heel syndrome: a prospective, double blind, randomized trial assessing the efficacy of a new electromagnetic shock wave device. J Foot Ankle Surg 2007;46:348–57. [18] Gollwitzer H, Saxena A, DiDomenico LA, Galli L, Bouché RT, Caminear DS, et al. Clinically relevant effectiveness of focused extracorporeal shock wave therapy in the treatment of chronic plantar fasciitis: a randomized, controlled multicenter study. J Bone Joint Surg Am 2015;97:701–8. [19] Marks W, Jackiewicz A, Witkowski Z, Kot J, Deja W, Lasek J. Extracorporeal shock-wave therapy (ESWT) with a new-generation pneumatic device in the treatment of heel pain. A double blind randomised controlled trial. Acta Orthop Belg 2008;74:98–101. [20] Rompe JD, Decking J, Schoellner C, Nafe Bernhard. Shock wave application for chronic plantar fasciitis in running athletes. A prospective, randomized, placebo-controlled trial. Am J Sports Med 2003;31:268–75. [21] Speed CA, Nichols D, Wies J, Humphreys H, Richards C, Burnet S, et al. Extracorporeal shock wave therapy for plantar fasciitis. A double blind randomised controlled trial. J Orthop Res 2003;21:937–40. [22] Gerdesmeyer L, Frey C, Vester J, Maier Markus, Weil Jr Lowell, Gerdesmeyer Ludger, et al. Radial extracorporeal shock wave therapy is safe and effective in the treatment of chronic recalcitrant plantar fasciitis: results of a confirmatory randomized placebo-controlled multicenter study. Am J Sports Med 2008;36:2100–9. [23] Ibrahim MI, Donatelli RA, Schmitz C, Hellman MA, Buxbaum Frederick. Chronic plantar fasciitis treated with two sessions of radial extracorporeal shock wave therapy. Foot Ankle Int 2010;31:391–7. [24] Malay DS, Pressman MM, Assili A, Kline Jason T, York Shane, Buren Ben, et al. Extracorporeal shockwave therapy versus placebo for the treatment of chronic proximal plantar fasciitis: results of a randomized, placebo-controlled, doubleblinded, multicenter intervention trial. J Foot Ankle Surg 2006;45:196–210. [25] Maier M, Milz S, Wirtz DC, Rompe JD, Schmitz C. Basic research of applying extracorporeal shockwaves on the musculoskeletal system. An assessment of current status. Orthopade 2002;31:667–77. [26] Yin MC, Ye J, Yao M, Cui Xue-Jun, Xia Ye, Shen Qi-Xing, et al. Is extracorporeal shock wave therapy clinical efficacy for relief of chronic, recalcitrant plantar fasciitis? A systematic review and meta-analysis of randomized placebo or active-treatment controlled trials. Arch Phys Med Rehabil 2014;95:1585–93. [27] Dizon JN, Gonzalez-Suarez C, Zamora MT, Gambito ED. Effectiveness of extracorporeal shock wave therapy in chronic plantar fasciitis: a metaanalysis. Am J Phys Med Rehabil 2013;92:606–20. [28] Zhiyun L, Tao J, Zengwu S. Meta-analysis of high-energy extracorporeal shock wave therapy in recalcitrant plantar fasciitis. Swiss Med Wkly 2013;143: w13825. [29] Aqil A, Siddiqui MR, Solan M, Redfern David J, Gulati Vivek, Cobb Justin P. Extracorporeal shock wave therapy is effective in treating chronic plantar fasciitis: a meta-analysis of RCTs. Clin Orthop Relat Res 2013;471:3645–52. [30] Othman Ahmed Mohamed Ahmed, Ragab Ehab Mohamed. Endoscopic plantar fasciotomy versus extracorporeal shock wave therapy for treatment of chronic plantar fasciitis. Orthop Surg 2010;130:1343–7. [31] Hua Chang, Liying Zheng. A comparative study of the efficacy of extracorporeal shock wave and ultrasound in the treatment of heel pain. Chin J Phys Med Rehabil 2003;25:599–601. [32] Konjen Nipaporn, Napnark Tapakorn, Janchai Siriporn. A comparison of the effectiveness of radial extracorporeal shock wave therapy and ultrasound therapy in the treatment of chronic plantar fasciitis: a randomized controlled trial. J Med Assoc Thai 2015;98(Suppl 1):S49–56. [33] Shipeng Pan, Gang Liu, Zhiwen Wang, Xinpeng Chen. Comparative analysis of the efficacy of shock wave and closed therapy for heel pain. J Pract Med Tech 2017;24:307–8. [34] Kudo Patricia, Dainty Katie, Clarfield Michael, Coughlin Larry, Lavoie Pauline, Lebrun Constance. Randomized, placebo-controlled, double-blind clinical trial evaluating the treatment of plantar fasciitis with an extracorporeal shockwave therapy (ESWT) device: a North American confirmatory study. J Orthop Surg Res 2005;115–23.
Please cite this article in press as: K. Sun, et al., Extracorporeal shock wave therapy versus other therapeutic methods for chronic plantar fasciitis, Foot Ankle Surg (2018), https://doi.org/10.1016/j.fas.2018.11.002
Foot and Ankle Surgery xxx (2018) xxx–xxx
Contents lists available at ScienceDirect
Foot and Ankle Surgery journal homepage: www.elsevier.com/locate/fas
Extracorporeal shock wave therapy versus other therapeutic methods for chronic plantar fasciitis Kai Sun, Haiyu Zhou, Wenxue Jiang* Tianjin First Center Hospital, Fukang Road No. 24, Nankai District, Tianjin, 300192, China
A R T I C L E I N F O
A B S T R A C T
Article history: Received 10 August 2018 Received in revised form 24 October 2018 Accepted 3 November 2018 Available online xxx
Background: To conduct a meta-analysis comparing the efficacy of general ESWT with that of other therapies and to assess its effectiveness in chronic plantar fasciitis. Methods: A literature search was performed in PubMed, Embase, Web of Science and the Cochrane Library for information from the earliest date of data collection to March 2018. Studies comparing the benefits and risks of extracorporeal shock wave therapy with those of other therapies for chronic plantar fasciitis were included. Statistical heterogeneity was quantitativelyevaluated bya X2 test with the significance set as P < 0.10 or I2 > 50%. Results: Thirteen trials consisting of 1,185 patients were included (637 patients were treated with ESWT; 548 patients, with OT). The results showed that patients treated with ESWT had increased success or improvement rates, an increased modified Roles & Maudsley (RM) score, a reduction of pain scales, reduced return to work time, and fewer complications than patients treated with other therapy methods (P < 0.1). Conclusions: Compared with patients who received other therapies for chronic plantar fasciitis, patients treated with ESWT responded better, had less complications and showed a clear difference in efficacy between ESWT and other therapy in chronic plantar fasciitis. Level of Evidence: Level IV, therapeutic study. © 2018 European Foot and Ankle Society. Published by Elsevier Ltd. All rights reserved.
Keywords: Extracorporeal shock wave therapy Other therapeutic Effectiveness Complications Chronic plantar fasciitis
1. Introduction Heel pain is a general term for the pain of the heel. It refers to a variety of chronic diseases, including plantar fasciitis on the internal and lateral aspect of the heel. Plantar fasciitis is a common cause of heel pain [1]. It occurs mostly among people aged 40–70 years old. The ratio of men to women is approximately 2:1. The aetiology and pathogenesis of heel pain are various and complex. Clinically, it is mainly caused by plantar aponeurosis, calcaneal fat pads, calcaneus bursitis, calcaneus hypertension, or lateral plantar nerve entrapment [2]. The cause of degeneration is repetitive microtears in the plantar fascia that overcome the body’s capacity to repair itself [2]. In general, plantar fasciitis is a self-limiting disease. Unfortunately, the time until resolution is often 6–18 months, which can lead to frustration for patients and physicians [3,4].
Abbreviations: ESWT, extracorporeal shock wave therapy; OT, other therapy; RM, roles & maudsley; RCT, randomized controlled trials. * Corresponding author. E-mail addresses: [email protected] (K. Sun), [email protected] (H. Zhou), [email protected] (W. Jiang).
Conservative lines of treatment include non-steroidal antiinflammatory drugs, heel pads or orthotics, physical therapy, stretching exercises, and corticosteroid injections. However, extracorporeal shockwave therapy is regarded as the mainstay of treatment and provides substantial relief to approximately 80% of patients [5]. Extracorporeal shock waves are focussed, single pressure pulses of microsecond duration and represent one of the most effective approaches to the treatment of chronic plantar fasciitis. Extracorporeal shock wave therapy (ESWT) has been recently used in the treatment of a number of musculoskeletal conditions, including insertional disorders such as plantar fasciitis [6,7]. Extracorporeal shock wave therapy (ESWT) has been used for the treatment of recalcitrant painful heel syndrome as an alternative to surgery, allowing fast recovery times without the necessity of reduced weightbearing or immobilization. The rationale for such an approach is the stimulation of soft tissue healing, reduction of calcification, inhibition of pain receptors, or denervation to achieve pain relief [8,9], although the true effects have not been established, and doses and regimes can vary. The effectiveness of ESWT in plantar fasciitis however, is controversial The purpose of this metanalysis therefore, was to compare the results of ESWT and other therapeutic modalities in the treatment of chronic plantar fasciitis.
https://doi.org/10.1016/j.fas.2018.11.002 1268-7731/© 2018 European Foot and Ankle Society. Published by Elsevier Ltd. All rights reserved.
Please cite this article in press as: K. Sun, et al., Extracorporeal shock wave therapy versus other therapeutic methods for chronic plantar fasciitis, Foot Ankle Surg (2018), https://doi.org/10.1016/j.fas.2018.11.002
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2. Materials and methods 2.1. Literature and search strategy Two different reviewers independently searched PubMed, Embase, Web of Science and the Cochrane Library for information from the inception of the databases to March 2018. The following related terms were searched: extracorporeal shock wave therapy; focused extracorporeal shock wave therapy; radial extracorporeal shock wave therapy; plantar fasciitis; plantar fasciopathy; chronic plantar fasciitis; heel pain; other therapeutic; placebo; and RCTs. The searching strategy was constructed by combining the above terms with “AND” or “OR”. The publication language was limited to English. We also screened the reference lists of retrieved articles so that relevant studies were not missed. 2.2. Study selection criteria Two different reviewers independently assessed the retrieved articles to determine whether they met the inclusion criteria. In
the case of disagreements, a third reviewer was involved in the discussion until a consensus was reached. Studies that met the following criteria were included in the current meta-analysis: investigations of patients suffering from heel pain and diagnosed with chronic plantar fasciitis; studies involving the comparison of ESWT without anaesthesia and sham therapy as a control; cohort studies; and randomized controlled trials (RCTs). Exclusion criteria included: (1) case-control studies, animal studies, cadaver studies, single case reports, comments, letters, editorials, protocols, guidelines, publications based on surgical registries, and review papers; (2) patients with the following characteristics: rheumatic or other systemic inflammatory disease, inflammatory disorders of the upper and/or lower ankle, collagenosis, diabetes mellitus or other metabolic diseases, tendon ruptures in the treatment area, neurological or vascular insufficiencies, nerve entrapment syndrome, hyperthyroidism, active malignant disease with or without metastases, Paget’ s disease, calcaneal fat pad atrophy, osteomyelitis or active infection or history of chronic infection in the treatment area, previous surgery for painful heel, unsuccessful prior ESWT, or bilateral heel pain.
Fig. 1. Flow chart illustrating the literature search. Table 1 Characteristics of the included studies. References
No. Patients ESWT
[33] [18] [32] [30] [23] [19] [22] [17] [24] [34] [31] [21] [16]
50 125 15 20 25 16 125 20 112 53 12 46 15
Gender (male:female)
Mean age (years)
OT
ESWT
OT
ESWT
OT
32 121 15 17 25 9 118 20 56 52 25 42 15
32:18 40:84 4:11 13:7 7:18 7:9 38:87 11:9 36:76 18:35 6:6 20:26 10:5
20:12 33:88 2:13 8:9 11:14 4:5 39:79 4:16 21:35 25:27 5:20 17:25 9:6
57.2 50.0 45.6 46.0 56.6 51.9 52.4 53.9 50.8 51.1 46.9 51.7 47.0
59.2 47.4 45.0 42.0 49.1 51.7 52.0 58.9 52.1 48.8 48.3 52.5 51.0
Mean duration of pain (range) (month)
Follow-up (months)
>6 >6 >12 >16 >6 >21 >25 >11 >31 >31 >31 >16 >16
3 3 6 11 6 6 6 3 6 6 6 6 3
ESWT: Extracorporeal Shockwave Therapy. OT: Other Therapeutic.
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Fig. 2. Risk of bias graph.
2.3. Data extraction and quality assessment Two different reviewers independently performed the data extraction and methodological quality assessment. Data extracted from the included studies consisted of authors, publication date, study design, number of patients, treatment approach, follow-up duration and outcome data for both extracorporeal shock wave therapy and other therapeutic groups. The outcome measures included success or improvement rates, the modified Roles & Maudsley (RM) score, reduction of pain scales, return to work time, and complications. The methodological quality of a study was evaluated in six domains, including sequence generation, allocation concealment, participants’ blinding, assessors’ blinding, incomplete data, selective reporting and other bias. Each included study could have an unclear risk, low risk or high risk of bias for each domain based on Cochrane’s Handbook 5.1.0. 2.4. Statistical analysis Statistical analyses were performed using Review Manager Software 5.3. For dichotomous outcomes, the odds ratio (OR) with a 95% CI (confidence interval) was calculated to estimate a pooled average difference between ESWT with OT. The WMD (weighted mean differences) and 95% CI were calculated for continuous outcomes. Statistical heterogeneity was quantitatively evaluated by a Chi-square test with the significance set as P < 0.10 or I2 > 50%. The data were presented in the form of Forest plots. Publication bias was assessed by a funnel plot. 3. Results 3.1. Literature search
Fig. 3. Risk of bias summary (+ indicates a low risk of bias, bias, ? indicates unclear or unknown risk of bias).
indicates a high risk of
The retrieval strategy is displayed in Fig. 1. In total, 330 potentially eligible citations were searched online. After removing duplicates, browsing titles and abstracts and reviewing the fulltext, 13 papers met the inclusion criteria. Among all the participants of the 13 papers, the outcomes for a total of 1185 patients were described, of which 637 patients were treated with ESWT and 548 patients with OT. The detailed characteristics of the studies are listed in Table 1. No other apparent bias was found among the included studies. Figs. 2 and 3 show the risk of bias summary.
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Fig. 4. Forest plot of comparison: success or improvement rates (ESWT = Extracorporeal Shock Wave Therapy; OT = Other Therapy; CI confidence interval, df degrees of freedom).
Fig. 5. Forest plot of comparison: Reduction of pain scales (ESWT = Extracorporeal Shock Wave Therapy; OT = Other Therapy; CI confidence interval, df degrees of freedom).
Fig. 6. Forest plot of comparison: RM scores (ESWT = Extracorporeal Shock Wave Therapy; OT = Other Therapy; CI confidence interval, df degrees of freedom).
3.2. Results of the meta-analysis Thirteen trials reported success or improvement rates. The pooled results showed that ESWT was related to a greater increase in success or improvement rates compared with OT, with an OR = 2.64; 95% CI, 2.06–3.39; P < 0.01, without significant heterogeneity (I2 = 35%) (Fig. 4). Eleven trials reported reduction of pain scales. The results showed that ESWT was related to a greater increase in the reduction of pain scales compared with OT, with SMD = 0.43; 95% CI, 0.31–0.55; P < 0.01, without significant heterogeneity (I2 = 28%) (Fig. 5). Five trials reported the modified Roles & Maudsley (RM) score. The results showed that ESWT was related to a greater increase in RM scores, with SMD = 0.39; 95% CI, 0.57 to 0.20; P < 0.01, without significant heterogeneity (I2 = 12%) (Fig. 6). Four trials reported return to work time. The results showed that OT was related to a greater increase in return to work time,
with SMD = 2.54; 95% CI, 2.89 to 2.20; P < 0.01, without significant heterogeneity (I2 = 0%) (Fig. 7). Eleven trials reported complications. The results showed that OT was related to a greater increase in complications, with OR = 0.50; 95% CI, 0.29–0.86; P < 0.01, without significant heterogeneity (I2 = 0%) (Fig. 8). 4. Discussion We conclude that other therapy, such as placebo treatment, had a negative influence on the outcome of patients treated with chronic plantar fasciitis, with more short-term complications and poorer long-term outcome compared with extracorporeal shock wave patients. The aim of our systematic review of the literature was to show whether other therapy, such as placebo treatment, leads to a worse outcome following chronic plantar fasciitis. ESWT therapy for chronic plantar fasciitis might be more effective than
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Fig. 7. Forest plot of comparison: return to work time (ESWT = Extracorporeal Shock Wave Therapy; OT = Other Therapy; CI confidence interval, df degrees of freedom).
Fig. 8. Forest plot of comparison: Complications (ESWT = Extracorporeal Shock Wave Therapy;OT = Other Therapy; CI confidence interval, df degrees of freedom).
other therapies and offer a safe alternative to treat chronic plantar fasciitis. Heel pain is a common symptom [10]. When standing and walking, the symptoms are worse. The aetiology and mechanisms are not clear, but studies have found that this disease is closely related to strain and bone degeneration [11–14]. The treatment of heel pain is mainly analgesic. The current treatment methods include two categories: conservative treatment and surgical treatment. Conservative treatment is local physical therapy, local blocking, activating blood circulation and so on [15–20]. Surgical treatment can be considered when conservative treatment is ineffective. The operation is selected according to the cause of the disease. Lateral nerve transaction can be useful for improving symptoms. For calcaneal spurs, spur resection is used, but sometimes bone spurs grow again or relapse [21–24]. Extracorporeal shock waves can propagate in three dimensions, and the propagation speed increases with pressure. It can pass through body fluids and tissues to reach the affected area [25]. In 1980, extracorporeal shock wave therapy was first used [26–28]. After the success of shock wave treatment of renal calculi, the scope of shock wave treatment gradually expanded from lithotripsy and treatment of fracture non-union to chronic pain treatment [29,30]. A prospective study of extracorporeal shock wave therapy for heel pain was carried out. Three months later, the therapeutic composition was 56% higher than that of the control group, and heel pain became the first orthopaedic disease to be treated by shock wave with FDA approval [31,32]. High intensity shock waves can produce super-stimulation of the nerve and tissue, release substances that inhibit pain, stimulate the pain nerve receptor, reduce nerve sensitivity and nerve conduction, and can also change nociceptors [33]. The frequency of pain acceptance changes the composition of the chemical medium around the nociceptor and inhibits the transmission of pain information and thereby alleviates pain [34].
Due to the energy of the extracorporeal shock waves, the patient may feel needle-like sensations. This should be explained to the patient before treatment. If the pain is aggravated, the patient should be revisited over time. This study has some limitations. It is difficult to design highquality studies regarding the effect of the ESWT on the outcomes of chronic plantar fasciitis, because participants cannot be randomly assigned to exposure groups, and blinding is only partly possible. Obtaining Level-I evidence for the impact of ESWT on the outcome of chronic plantar fasciitis is difficult. Because of partial blinding, a high-quality study cannot be performed. We chose to include all comparative studies in this systematic review to represent the best evidence available at present. Differentiation between retrospective and prospective trials can be difficult because many authors present a study with prospective data collection and retrospective analysis of the data as being prospective in design. Scoring of the methodology, however, showed that the studies included in this review were comparable and that pooling them was therefore justifiable. 5. Conclusion This is a meta-analysis comparing the efficacy of ESWT with other therapy in chronic plantar fasciitis. The most important finding was the clear difference in the efficacy between ESWT and other therapy for chronic plantar fasciitis. The patients treated with ESWT showed better success or improvement rates in the modified Roles & Maudsley (RM) score, reduction in pain scales and return to work time and less complications than the other therapeutic methods.It also appears reasonable to conclude that the patient treated with other therapy at least benefits from a thorough analysis of existing complications and improvement of his or her medical condition. Further higher-quality, multicentre,
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prospective studies with good design, a large number of participants and long-term follow-up RCTs are necessary to confirm these results. Competing interests The authors declare that they have no competing interests. Funding No. Ethical review committee statement The study was approved by the institutional review board of Tianjin First Center Hospital; Tianjin, China. A Statement of the location The work was performed in Tianjin First Center Hospital. Authors’ contributions Kai Sun designed the study protocol, participated in the data analysis, and drafted the manuscript. Haiyu Zhou and Wenxue Jiang participated in the analysis and revision of the manuscript. Acknowledgements The authors would like to thank Tianjin First Center Hospital and Tianjin First Center Hospital for providing the database. References [1] Rompe JD. Plantar fasciopathy. Sports Med Arthrosc 2009;17:100–4. [2] Rompe JD, Furia J, Weil L, Maffulli N. Shock wave therapy for chronic plantar fasciopathy. Br Med Bull 2007;81–82:183–208. [3] Lim AT, How CH, Tan B. Management of plantar fasciitis in the outpatient setting. Singapore Med J 2016;57:168–70. [4] Mardani-Kivi M, Karimi Mobarakeh M, Hassanzadeh Z, Mirbolook A, Asadi K, Ettehad H, et al. Treatment outcomes of corticosteroid injection and extracorporeal shock wave therapy as two primary therapeutic methods for acute plantar fasciitis: a prospective randomized clinical trial. J Foot Ankle Surg 2015;54:1047–52. [5] Roca B, Mendoza MA, Roca M. Comparison of extracorporeal shock wave therapy with botulinum toxin type A in the treatment of plantar fasciitis. Disabil Rehabil 2016;38:2114–21. [6] Rompe JD, Cacchio A, Weil L, Furia JP, Haist J, Reiners V, et al. Plantar fasciaspecific stretching versus radial shock-wave therapy as initial treatment of plantar fasciopathy. J Bone Joint Surg Am 2010;92:2514–22. [7] Rompe JD, Furia J, Cacchio A, Schmitz Christoph, Maffullie Nicola. Radial shock wave treatment alone is less efficient than radial shock wave treatment combined with tissuespecific plantar fascia-stretching in patients with chronic plantar heel pain. Int J Surg 2015;24:135–42. [8] Lee SJ, Kang JH, Kim JY, Kim JH, Yoon SR, Jung KI. Dose-related effect of extracorporeal shock wave therapy for plantar fasciitis. Ann Rehabil Med 2013;37:379–88. [9] Park JW, Yoon K, Chun KS, Lee JY. Long-term outcome of low-energy extracorporeal shock wave therapy for plantar fasciitis: comparative analysis according to ultrasonographic findings. Ann Rehabil Med 2014;38:534–40. [10] Rompe JD, Schoellner C, Nafe B. Evaluation of low-energy extracorporeal shock-wave application for treatment of chronic plantar fasciitis. J Bone Joint Surg Am 2002;84-A:335–41. [11] Vahdatpour B, Sajadieh S, Bateni V, Karami Mehdi, Sajjadieh Hamidreza. Extracorporeal shock wave therapy in patients with plantar fasciitis. A randomized, placebocontrolled trial with ultrasonographic and subjective outcome assessments. J Res Med Sci 2012;17:834–8. [12] Yan W, Sun S, Li X. Therapeutic effect of extracorporeal shock wave combined with orthopaedic insole on plantar fasciitis. Zhong Nan Da Xue Bao Yi Xue Ban 2014;39:1326–30.
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Please cite this article in press as: K. Sun, et al., Extracorporeal shock wave therapy versus other therapeutic methods for chronic plantar fasciitis, Foot Ankle Surg (2018), https://doi.org/10.1016/j.fas.2018.11.002