NCT02608723

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Asociacion Colaboracion Cochrane Iberoamericana · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Plantar Fasciitis
• Pain

Interventions

Type	Name	Description
DEVICE	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.
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.
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.

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2015-11-20
• Last updated: 2015-11-20

Locations

1 site across 1 country: Spain