Randomized, placebo‐controlled, double‐blind clinical trial evaluating the treatment of plantar fasciitis with an extracoporeal shockwave therapy (ESWT) device: A North American confirmatory study

Abstract

Despite numerous publications and clinical trials, the results of treatment of recalcitrant chronic plantar fasciitis with extracorporeal shockwave therapy (ESWT) still remain equivocal as to whether or not this treatment provides relief from the pain associated with this condition. The objective of this study was to determine whether extracorporeal shock wave therapy can safely and effectively relieve the pain associated with chronic plantar fasciitis compared to placebo treatment, as demonstrated by pain with walking in the morning. This was set in a multicenter, randomized, placebo-controlled, double-blind, confirmatory clinical study undertaken in four outpatient orthopedic clinics. The patients, 114 adult subjects with chronic plantar fasciitis, recalcitrant to conservative therapies for at least 6 months, were randomized to two groups. Treatment consisted of approximately 3,800 total shock waves (AE10) reaching an approximated total energy delivery of 1,300 mJ/mm 2 (EDþ) in a single session versus placebo treatment. This study demonstrated a statistically significant difference between treatment groups in the change from baseline to 3 months in the primary efficacy outcome of pain during the first few minutes of walking measured by a visual analog scale. There was also a statistically significant difference between treatments in the number of participants whose changes in Visual Analog Scale scores met the study definition of success at both 6 weeks and 3 months posttreatment; and between treatment groups in the change from baseline to 3 months posttreatment in the Roles and Maudsley Score. The results of this study confirm that ESWT administered with the Dornier Epos Ultra is a safe and effective treatment for recalcitrant plantar fasciitis. ß

Resistant plantar fasciopathy: shock wave versus endoscopic plantar fascial release

“…Many, but not all, randomized, blinded and controlled multicenter trials have demonstrated that ESWT is more effective than placebo treatment [18,24,34]. However, some studies showed disappointing results [6,13,33].…”

Shock Wave Therapy Versus Progressive Pressure Release on Myofascial Trigger Points

“…9 Extracorporeal shock wave device can transform the impulse sound wave into accurate trajectory shockwave, producing an effective pain-relief effect on extensive human tissue through the orientation and shifting of the therapeutic probe. 10 The consistent use of shock waves in orthopedics for the treatment of myofascial syndromes started in early 2000. Initially, radial shock waves (r-ESWT) were used for these applications, but focused shock waves followed shortly after.…”

An Evaluation of the Efficacy of ESWT and Placebo-ESWT Treatment for Chronic Plantar Fasciitis

“…There have been many studies evaluating the efficacy of ESWT in the treatment of plantar fasciitis and although the majority of these studies have reported effective and successful results [5,7,[9][10][11][12][13][14][15][16][17][18][19][20], some researchers have stated that ESWT has had no effect [6,[21][22][23].…”