Shock Wave Therapy: Do the External Appearance of the Device Influence Clinical Outcomes?
NCT ID: NCT02608723
Last Updated: 2015-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
135 participants
INTERVENTIONAL
2014-06-30
2015-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Standard shock waves device
3 sessions were applied: one per week.
Standard shock waves 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.
Austere shock waves device
3 sessions were applied: one per week.
Austere shock waves 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
3 sessions were applied: one per week.
Sophisticated shock waves 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.
Interventions
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Standard shock waves 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.
Austere shock waves 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
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.
Eligibility Criteria
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Inclusion Criteria
2. Being able to understand the explanations about the potential benefits and risks of study participation.
3. 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.
4. With a duration of symptoms ≥ 6 months at the time of study entry.
5. Having received conservative therapy without success, at least two treatments. Treatments may have been made isolated, combined or consecutively.
Exclusion Criteria
2. Hiper/ hypothyroidism.
3. Diabetes mellitus.
4. Treatment with anticoagulants
5. Inflammatory diseases.
18 Years
ALL
No
Sponsors
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Asociacion Colaboracion Cochrane Iberoamericana
OTHER
Responsible Party
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Principal Investigators
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Antoni Morral, PhDc
Role: PRINCIPAL_INVESTIGATOR
Rehabilitation Center "Salut i Esport"
Locations
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Rehabilitation Center "Salut i Esport"
Santa Perpètua de Gaià, Barcelona, Spain
Countries
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Other Identifiers
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1304
Identifier Type: -
Identifier Source: org_study_id