Shock Wave Therapy: Do the External Appearance of the Device Influence Clinical Outcomes?

Study Overview
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Brief Summary
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To check in patients suffering from chronic plantar fasciitis treated with shock wave therapy, if the outward appearance of the device affects clinical outcomes.

Detailed Description
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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.

Official Title
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Chronic Plantar Fasciitis Treated With Shock Wave Therapy: Do the External Appearance of the Device Influence Clinical Outcomes? A Randomized Controlled Clinical Trial.

Conditions
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Plantar Fasciitis, Pain

Intervention / Treatment
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* Device: Standard shock waves device
* Device: Austere shock waves device
* Device: Sophisticated shock waves device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than 18 years. Being able to understand the explanations about the potential benefits and risks of study participation. Diagnosis of chronic plantar fasciitis. Proven by clinical examination: Meeting at least 2 of the following criteria: Tenderness in the proximal insertion of the plantar fascia (area of the medial calcaneal tuberosity). Pain during the first steps to get out of bed in the morning and / or after a period of rest time. With a duration of symptoms ≥ 6 months at the time of study entry. Having received conservative therapy without success, at least two treatments. Treatments may have been made isolated, combined or consecutively. Exclusion Criteria: Bilateral plantar fasciitis. Hiper/ hypothyroidism. Diabetes mellitus. Treatment with anticoagulants Inflammatory diseases.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard shock waves device<br>3 sessions were applied: one per week. | Device: Standard shock waves device<br>* 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.<br>|
| Active Comparator: Austere shock waves device<br>3 sessions were applied: one per week. | Device: Austere shock waves device<br>* 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.<br>|
| Active Comparator: Sophisticated shock waves device<br>3 sessions were applied: one per week. | Device: Sophisticated shock waves device<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function of the foot | FFI (Foot Function Index) questionnaire | Four months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | VAS (Visual Analogical Scale) | Four months | 
| Plantar fascia thickness | Ultrasounds | Four months | 
| Perception of patient recovery | Likert scale | Four months | 
| Painkillers consumption | Painkillers consumption | Four months | 
| Adverse effects | Adverse effects | Four months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shock wave, plantar fasciitis, placebo effect, nocebo effect