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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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 appl
Sponsor: Asociacion Colaboracion Cochrane Iberoamericana

Current Primary Outcome: Function of the foot [ Time Frame: Four months ]

FFI (Foot Function Index) questionnaire


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pain [ Time Frame: Four months ]
    VAS (Visual Analogical Scale)
  • Plantar fascia thickness [ Time Frame: Four months ]
    Ultrasounds
  • Perception of patient recovery [ Time Frame: Four months ]
    Likert scale
  • Painkillers consumption [ Time Frame: Four months ]
    Painkillers consumption
  • Adverse effects [ Time Frame: Four months ]
    Adverse effects


Original Secondary Outcome: Same as current

Information By: Asociacion Colaboracion Cochrane Iberoamericana

Dates:
Date Received: November 13, 2015
Date Started: June 2014
Date Completion:
Last Updated: November 17, 2015
Last Verified: November 2015