Fasciitis, Plantar Clinical Trial
Official title:
The Effectiveness of Extracorporeal Shock Wave Therapy for Patients With Plantar Fasciitis Who Satisfy a Clinical Prediction Rule
Radial extracorporeal shock wave therapy (rESWT) has been previously demonstrated as an efficient treatment option for heel pain associated with chronic proximal plantar fasciitis when administered in three sessions. The present study tested the hypothesis that heel pain associated with chronic proximal plantar fasciitis can also be treated successfully with rESWT when only two treatment sessions are performed.
Plantar fasciitis, the most common cause of heel pain, accounts for approximately 11-15% of
foot symptoms presenting to physicians. In the United States, more than two million
individuals are treated for PF on an annual basis. The term Plantar Fasciitis implies an
inflammatory condition by the suffix 'itis'. However, various lines of evidence indicate
that this disorder is better classified as 'fasciosis' or 'fasciopathy'. Details about
etiology, pathogenesis, risk factors, diagnosis and general treatment strategies for plantar
fasciitis have been provided in a series of comprehensive reviews recently. Briefly, both
athletes and the elderly commonly present to physicians with plantar fasciitis, and the
diagnosis of plantar fasciitis is usually based on the patient's history and clinical
examination. It has been recommended in the literature to start treatment of plantar
fasciitis with conservative treatment modalities, including physical therapy, stretching,
inserts/orthotics etc. For patients not responding to conservative treatment for 6 months
(between 10% and 20% of all patients) extracorporeal shock wave therapy (ESWT) should be
considered. In case a patient does not benefit from ESWT either, surgical intervention
should be taken into account.
Several randomized, controlled trials of ESWT with focused shock waves for chronic plantar
fasciitis were published, demonstrating favourable results in the range of 50% to 70% after
a followup period of three months after treatment. Besides this, a recent study demonstrated
safety and efficacy of radial extracorporeal shock wave therapy (rESWT) for chronic plantar
fasciitis (Gerdesmeyer et al., Am J Sports Med 2008 Nov;36(11):2100-9). These authors
administered rESWT or placebo treatment in three sessions, each two weeks (±4 days) apart
and evaluated the treatment outcome at twelve weeks and twelve months after the first
session. The authors found a statistically significant (p < 0.05) difference in the
reduction of the mean Visual Analog Scale composite score between the patients treated with
rESWT and the placebo-treated patients both at twelve weeks and twelve months from baseline.
To further evaluate the potential of rESWT to become a routine therapeutic modality in the
treatment of chronic plantar fasciitis, the investigators of the present study identified
the following questions not addressed in the study by Gerdesmeyer et al. (2008). First, it
is unknown whether treatment success can also be reached by two rESWT sessions one week
apart, rather than by three rESWT sessions each two weeks apart as applied by Gerdesmeyer et
al. (2008). Anecdotal reports by colleagues in Europe indicated that this could indeed be
the case. Second, immediate return to normal daily life activities (including sports
activities) and normal daily shoe wear indicates that patients suffering from chronic
plantar fasciitis and treated with rESWT experience profound pain relief already much
earlier than three months after the first rESWT session, applied as first followup in the
study by Gerdesmeyer et al. (2008).
Therefore the hypothesis was tested in the present prospective, randomized, double-blinded,
placebo-controlled study that treatment of chronic plantar fasciopathy with two rESWT
sessions one week apart will result in profound pain relief compared to placebo treatment
already four weeks after the first rESWT treatment, lasting for at least six months.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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