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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard shock waves device | Active Comparator | 3 sessions were applied: one per week. |
|
| Austere shock waves device | Active Comparator | 3 sessions were applied: one per week. |
|
| Sophisticated shock waves device | Active Comparator | 3 sessions were applied: one per week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard shock waves device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Function of the foot | FFI (Foot Function Index) questionnaire | Four months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | VAS (Visual Analogical Scale) | Four months |
| Plantar fascia thickness | Ultrasounds | Four months |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Antoni Morral, PhDc | Rehabilitation Center "Salut i Esport" | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehabilitation Center "Salut i Esport" | Santa Perpètua de Gaià | Barcelona | 08130 | Spain |
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| ID | Term |
|---|---|
| D036981 | Fasciitis, Plantar |
| D010146 | Pain |
| ID | Term |
|---|---|
| D005208 | Fasciitis |
| D009140 | Musculoskeletal Diseases |
| D005534 | Foot Diseases |
| D009461 | Neurologic Manifestations |
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| Austere shock waves device | 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. |
|
| Sophisticated shock waves device | 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. |
|
| Perception of patient recovery | Likert scale | Four months |
| Painkillers consumption | Painkillers consumption | Four months |
| Adverse effects | Adverse effects | Four months |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |