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document
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 . 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 ( +/-10 ) reaching an approximated total energy delivery of 1,300 mJ/mm ( 2 ) ( ED+ ) 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 .
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Intervention_Control
placebo-controlled
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Intervention_Physical
extracoporeal shockwave therapy
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Intervention_Physical
extracorporeal shockwave therapy ( ESWT )
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Intervention_Physical
3,800 total shock waves
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Intervention_Control
placebo treatment
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Intervention_Physical
ESWT
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Outcome_Other
relief
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Outcome_Pain
the pain
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Outcome_Other
safely
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Outcome_Other
effectively relieve the pain
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Outcome_Pain
pain
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Outcome_Other
the first few minutes
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Outcome_Pain
visual analog scale
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Outcome_Pain
Visual Analog Scale scores
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Outcome_Pain
Roles and Maudsley Score
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Outcome_Other
safe
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Outcome_Other
effective
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Participant_Condition
plantar fasciitis
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Participant_Condition
recalcitrant chronic plantar fasciitis
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Participant_Sample-size
four outpatient
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Participant_Sample-size
114
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Participant_Age
adult subjects
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Participant_Condition
chronic plantar fasciitis , recalcitrant to conservative therapies