To check in patients suffering from chronic plantar fasciitis treated with shock wave therapy, if the outward appearance of the device affects clinical outcomes.
Study Design: a controlled, randomized, parallel assessor-blinded clinical trial. Patients suffering from chronic plantar fasciitis (duration more than 6 months) will be assigned to three different groups: * Group I: Treatment applied by standard shock waves device. * Group II: Shock wave therapy applied by a modified standard device to offer more attractive, more technical, smarter, better appearance, larger and with an expansion of external information devices more sophisticated. * Group III: Shock wave therapy applied by a modified standard device to offer a more austere, disfigured, unattractive, modest and smaller external appearance. The shock waves emitted to the 3 devices will be identical; the only difference will be the external image of the device. The main outcome will be the function of the foot by the FFI (Foot Function Index) questionnaire. As secondary variables: pain by VAS (Visual Analogical Scale) in different situations, the plantar fascia thickness measured by ultrasound, and the perception of patient recovery measured with the Likert scale. Adverse effects, painkillers consumption and pain experienced during the treatment of shock waves were also assessed. The patients will be followed and monitored for a month, two months and four months after treatment finished. For the statistical analysis of clinical variables, ANOVA (analysis of variance) will be performed to check whether the evolution of patients over time was different depending on the device applied.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
135
3 sessions were applied: one per week. Energy flux density 0,18 mJ/mm2. Frequency: 8 Hz. 2500 shockwaves/session. The shock waves emitted to the 3 devices are identical; the only difference is the external image of the device.
3 sessions were applied: one per week. Energy flux density 0,18 mJ/mm2. Frequency: 8 Hz. 2500 shockwaves/session. The shock waves emitted to the 3 devices are identical; the only difference is the external image of the device.
3 sessions were applied: one per week. Energy flux density 0,18 mJ/mm2. Frequency: 8 Hz. 2500 shockwaves/session. The shock waves emitted to the 3 devices are identical; the only difference is the external image of the device.
Rehabilitation Center "Salut i Esport"
Santa Perpètua de Gaià, Barcelona, Spain
Function of the foot
FFI (Foot Function Index) questionnaire
Time frame: Four months
Pain
VAS (Visual Analogical Scale)
Time frame: Four months
Plantar fascia thickness
Ultrasounds
Time frame: Four months
Perception of patient recovery
Likert scale
Time frame: Four months
Painkillers consumption
Painkillers consumption
Time frame: Four months
Adverse effects
Adverse effects
Time frame: Four months
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