Extracorporeal Shockwave Therapy Versus Placebo for the Treatment of Chronic Proximal Plantar Fasciitis: Results of a Randomized, Placebo-Controlled, Double-Blinded, Multicenter Intervention Trial

doi:10.1053/j.jfas.2006.04.007

The Journal of Foot and Ankle Surgery

Volume 45, Issue 4, July–August 2006, Pages 196-210

https://doi.org/10.1053/j.jfas.2006.04.007 Get rights and content

Extracorporeal shockwave therapy (ESWT) has demonstrated efficacy in the treatment of recalcitrant proximal plantar fasciitis. The objective of this investigation was to compare the outcomes of participants treated with a new ESWT device with those treated with placebo. A total of 172 volunteer participants were randomized in a 2:1 active-to-placebo ratio in this prospective, double-blind, multicenter trial conducted between October 2003 and December 2004. ESWT (n = 115) or placebo control (n = 57) was administered on a single occasion without local or systemic anesthesia or sedation, after which follow-up was undertaken. The primary outcomes were the blind assessor’s objective, and the participant’s subjective assessments of heel pain during the first 3 months of follow-up. Participants were also followed up to 1 year to identify any adverse outcomes that may have been related to the shockwave device. On the visual analog scale, the blind assessor’s objective assessment of heel pain displayed a mean reduction of 2.51 in the shockwave group and 1.57 in the placebo group; this difference was statistically significant (P = .045). On the visual analog scale, the participant’s self-assessment of heel pain displayed a mean reduction of 3.39 in the shockwave group and 1.78 in the placebo group; this difference was statistically significant (P < .001). No serious adverse events were observed at any time. It was concluded that ESWT was both efficacious and safe for participants with chronic proximal plantar fasciitis that had been unresponsive to exhaustive conservative treatment.

Section snippets

Materials and Methods

An FDA-approved, randomized, placebo-controlled, double-blinded, multicentered clinical trial to compare the efficacy and safety of the Orthospec device was designed and undertaken at clinical centers in Pennsylvania, Connecticut, and Maryland. Figure 2 schematically depicts the organization and flow of the investigation.

Results

A total of 196 participants were screened, 172 were randomized to treatment, and 152 completed the 12-week efficacy trial. A total of 168 participants had at least 1 follow-up visit and were included in analyses of efficacy. Inspection of the distributions of the data confirmed that our statistical assumptions were met. The 172 participants had a mean age of 51 years, 33% were men, the mean weight was 184 pounds, 87% were white, and the mean duration of foot pain was 30 months. Baseline

Discussion

The Orthospec ESWT device used in this study uses an electrohydraulic, or “spark-gap”, method of creating therapeutic shockwaves. In this system, an electrode ignites an electrical charge within a water-filled, stainless-steel, semi-ellipsoid chamber, evaporating a small portion of the water contained in the chamber and creating a shockwave that is reflected outward. The portable shockwave generator used in this study targets the shockwaves to a 35-mm diameter therapy zone that enables

Summary and Conclusions

The results of this clinical investigation demonstrate the safety and efficacy of the Orthospec Extracorporeal Shockwave Therapy device for treatment of recalcitrant proximal plantar fasciitis. The study achieved statistical significance in its protocol-defined primary endpoint (P = .045), change from baseline in the investigator’s assessment of heel pain at 3 months. When participants were assessed by whether they achieved a clinical response in the primary endpoint, the number of responders

Acknowledgments

We would like to thank Donald R. Green, DPM, Luke D. Cicchinelli, DPM, Alan J. Mlodzienski, DPM, and Michael S. Downey, DPM, for their thoughtful critiques of our manuscript. We would also like to thank Jacqueline Rosenzweig for her assistance in scheduling participants and organizing and maintaining case report forms, and Sheryl Skinner of Medispec LTD for her site management and monitoring efforts.

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A comparative study between intralesional platelet rich plasma injection and extracorporeal shockwave therapy for the treatment of plantar fasciitis
2021, Journal of Arthroscopy and Joint Surgery
Plantar Fasciitis is a widely prevalent condition and is extremely disabling if it remains unresolved. Despite many available treatment modalities, the management of recalcitrant cases is still a dilemma. We conducted this study to evaluate and compare the role of two novel modalities: Intralesional PRP (Platelet Rich Plasma) injection and Extra Corporeal Shockwave Therapy (ESWT) for the management of this condition.
60 patients with a clinical diagnosis of recalcitrant plantar fasciitis were randomized into 2 groups; PRP Group (n = 30) and ESWT Group (n = 30). In PRP group patients received 3 intralesional injections of PRP and in ESWT group 3 sessions of Extra Corporeal Shockwave Therapy were administered. The Primary outcome measures were Visual Analogue Scale (VAS) score, American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score, Roles and Maudsley Index and Heel Tenderness Index (HTI). The secondary outcome measures were complications. The patients were followed up for a period of 6 months and evaluated for various scores.
At 6 months follow-up, significant results were found only on VAS score for both groups (p-value <0.05). However, both modalities resulted in significant clinical improvement with no complications reported. No statistically significant differences were reported between the two test groups.
Both autologous PRP and ESWT can become extremely useful modalities for management of recalcitrant cases of plantar fasciitis with no known adverse effects.
Extracorporeal shock wave therapy versus other therapeutic methods for chronic plantar fasciitis
2020, Foot and Ankle Surgery
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.
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 quantitatively evaluated by a X² test with the significance set as P < 0.10 or I² > 50%.
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).
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.
Extracorporeal Shockwave Therapy Plus Rehabilitation for Patients With Chronic Plantar Fasciitis Might Reduce Pain and Improve Function but Still Not Lead to Increased Activity: A Case-Series Study With Multiple Outcome Measures
2018, Journal of Foot and Ankle Surgery
Plantar fasciitis is a common cause of plantar-aspect heel pain. Although many patients will improve, a proportion will have ongoing and sometimes debilitating symptoms. Evidence from randomized controlled trials has shown that extracorporeal shockwave therapy (ESWT) results in benefits in treating pain. However, uncertainties remain whether these benefits translate to improvements in overall function. The present prospective case series examined the results from 35 patients with chronic plantar fasciitis who had undergone a course of ESWT in addition to a graded rehabilitation program. Of the 35 subjects, 34% were male, and the median age was 50.9 years. The duration of symptoms before ESWT was 24 months. The results of the present case series demonstrated statistically significant improvements in measures of self-reported “average pain” from a median of 7.0 of 10 at baseline to 5.0 of 10 at 3 months (p < .001) and of “worst pain” from 9.0 of 10 at baseline to 7.0 of 10 at 3 months (p < .001). In addition, significant improvements were found in several validated patient-rated outcome measures of local foot/ankle function but not in overall markers of health, anxiety/depression scores, or activity levels, despite the improvements in pain. No statistically significant correlations were found between gender, age, or chronicity of symptoms and the improvements seen. No significant side effects occurred in the present study. The results of our series support the use of ESWT for patients with chronic plantar fasciitis for local pain symptoms; however, uncertainties remain regarding global benefits to health.
Complications of extracorporeal shockwave therapy in plantar fasciitis: Systematic review
2017, International Journal of Surgery
Extracorporeal shockwave therapy (ESWT) seems to be an effective treatment for plantar fasciitis (PF) and is assumed to be safe. No systematic reviews have been published that specifically studied the complications and side effects of ESWT in treating PF. Aim of this systematic review is therefore to evaluate the complications and side effects of ESWT in order to determine whether ESWT is a safe treatment for PF.
For this systematic review the databases PubMed, MEDLINE, Cochrane and Embase were used to search for relevant literature between 1 January 2005 and 1 January 2017. PRISMA guidelines were followed.
Thirty-nine studies were included for this review, representing 2493 patients (2697 heels) who received between 6424 and 6497 ESWT treatment sessions, with an energy flux density between 0.01 mJ/mm² and 0.64 mJ/mm² and a frequency of 1000–3800 SWs. Average follow-up was 14.7 months (range: 24 h - 6 years). Two complications occurred: precordial pain and a superficial skin infection after regional anaesthesia. Accordingly, 225 patients reported pain during treatment and 247 reported transient red skin after treatment. Transient pain after treatment, dysesthesia, swelling, ecchymosis and/or petechiae, severe headache, bruising and a throbbing sensation were also reported.
ESWT is likely a safe treatment for PF. No complications are expected at one-year follow-up. However, according to the current literature long-term complications are unknown. Better descriptions of treatment protocols, patient characteristics and registration of complications and side effects, especially pain during treatment, are recommended.
Treatment of Plantar Fasciitis With Radial Soundwave “Early” Is Better Than After 6 Months: A Pilot Study
2017, Journal of Foot and Ankle Surgery
Extracorporeal shock wave therapy/radial soundwave therapy has been predominantly used for chronic or recalcitrant plantar fasciitis with strong scientific evidence of reliable outcomes. Most of the studies included patients with plantar fasciitis with symptoms >6 months in duration. Only 2 known studies have investigated acute plantar fasciitis, which is <6 weeks in duration. They both found suboptimal results for the use of extracorporeal shock wave therapy. To the best of our knowledge, no studies have investigated radial soundwave therapy for the subacute stage or early stage of plantar fasciitis. Data were prospectively collected from 28 eligible patients who underwent radial soundwave therapy (RSWT) during a 9-month period in 2014. Of the 28 subjects, 14 were enrolled in the “early group” with a symptom duration of <3 months and 14 in the “standard/control” group with a symptom duration of >6 months. The pretreatment and posttreatment visual analog scale scores, Roles-Maudlsey scores, and activity level were recorded and compared. The early implementation of RSWT yielded comparable outcomes when compared with the standard group. RSWT is a valid treatment modality that can be implemented soon after the initial treatment options or first-phase treatment options have failed. Early treatment is more likely to allow for maintenance of patients' activity level. Also, waiting 6 months to treat plantar fasciitis with RSWT results in delays and inferior results. Early treatment is better for active and athletic patients.
Schneider H, Baca J, Carpenter B, Dayton P, Fleischer A, Sachs B. American College of Foot and Ankle Surgeons Clinical Consensus Statement: Diagnosis and Treatment of Adult Acquired Infracalcaneal Heel Pain. J Foot Ankle Surg 2018
2018, Journal of Foot and Ankle Surgery

View all citing articles on Scopus

: Disclosure: This multicenter, double-blinded clinical investigation, entitled protocol PF-01: A Comparative Randomized Placebo-Controlled Clinical Trial of Orthospec™ Versus Orthospec™ Placebo for the Relief of Pain in the Treatment of Proximal Plantar Fasciitis, was conducted under the United States Food and Drug Administration Investigational Device Exemption #G020175 to determine the safety and efficacy of the Orthospec™ ESWT device. The study sponsor, Medispec LTD, 12850 Middlebrook Road, Suite 1, Germantown, MD 20874, provided the extracorporeal shockwave therapy and plantar pressure assessment devices, and funded the investigation.

¹: Ankle and Foot Medical Centers of the Delaware Valley, Penn-Presbyterian Medical Center, Postdoctoral Research Fellow, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, PA

²: Chief, Section of Podiatric Surgery, Yale—New Haven Hospital, Clinical Assistant Professor, Orthopaedics and Rehabilitation, Yale School of Medicine, New Haven Foot Surgeons, New Haven, CT

³: Podiatric Director, Shady Grove Wound Center, Shady Grove Podiatry, Gaithersburg, MD

⁴: Chief Resident, Penn—Presbyterian Medical Center, Philadelphia, PA

⁵: Chief Resident, Podiatric Surgery, Yale—New Haven Hospital, New Haven, CT

⁶: Chief Resident, Podiatric Surgery, Yale—New Haven Hospital, New Haven, CT

⁷: Statistical Consultant, Montgomery Village, MD

⁸: Ankle and Foot Medical Centers of the Delaware Valley, Philadelphia, PA

⁹: Shady Grove Podiatry, Gaithersburg, MD

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Original researchExtracorporeal Shockwave Therapy Versus Placebo for the Treatment of Chronic Proximal Plantar Fasciitis: Results of a Randomized, Placebo-Controlled, Double-Blinded, Multicenter Intervention Trial

Section snippets

Materials and Methods

Results

Discussion

Summary and Conclusions

Acknowledgments

Clin Podiatr Med Surg

J Shoulder Elbow Surg

Clin Podiatr Med Surg

Ultrasound Med Biol

J Orthop Sci

J Foot Ankle Surg

J Orthop Res

J Orthop Res

The anatomical basis of inferior calcaneal lesions

J Am Podiatr Med Assoc

Heel pain syndromepathomechanics and nonsurgical treatment

J Am Podiatr Med Assoc

Comparison of custom and prefabricated orthoses in the initial treatment of proximal plantar fasciitis

Foot Ankle Int

Risk factors for plantar fasciitisa matched case-control study

J Bone Joint Surg Am

Volume of ambulatory care visits and patterns of care for patients diagnosed with plantar fasciitisa national study of medical doctors

Foot Ankle Int

Posterior tibial nerve block in the therapeutic management of painful calcaneal spur (plantar fasciitis)a preliminary experience

Can J Anaesth

Tissue-specific plantar fascia-stretching exercise enhances outcomes in patients with chronic heel pain. A prospective, randomized study

J Bone Joint Surg Am

Mechanical treatment of plantar fasciitis. A prospective study

J Am Podiatr Med Assoc

Night splint treatment for plantar fasciitis. A prospective randomized study

Clin Orthop

Steroid injection for heel pain: evidence of short-term effectiveness. A randomized controlled trial

Rheumatology (Oxford)

Conservative treatment of plantar fasciitis. A prospective study

J Am Podiatr Med Assoc

Treatment of plantar fasciitis by iontophoresis of 0.4% dexamethasone. A randomized, double-blind, placebo-controlled study

Am J Sports Med

A retrospective comparison of endoscopic plantar fasciotomy to open plantar fasciotomy with heel spur resection for chronic plantar fasciitis/heel spur syndrome

J Foot Ankle Surg

Endoscopic plantar fasciotomy versus traditional open heel spur surgerya prospective study

J Foot Ankle Surg

Original research
Extracorporeal Shockwave Therapy Versus Placebo for the Treatment of Chronic Proximal Plantar Fasciitis: Results of a Randomized, Placebo-Controlled, Double-Blinded, Multicenter Intervention Trial