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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02608723
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
Asociacion Colaboracion Cochrane Iberoamericana

Tracking Information
First Submitted Date  ICMJE November 13, 2015
First Posted Date  ICMJE November 20, 2015
Last Update Posted Date November 20, 2015
Study Start Date  ICMJE June 2014
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2015)
Function of the foot [ Time Frame: Four months ]
FFI (Foot Function Index) questionnaire
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2015)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Shock Wave Therapy: Do the External Appearance of the Device Influence Clinical Outcomes?
Official Title  ICMJE 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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Plantar Fasciitis
  • Pain
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: Standard shock waves device
    3 sessions were applied: one per week.
    Intervention: Device: Standard shock waves device
  • Active Comparator: Austere shock waves device
    3 sessions were applied: one per week.
    Intervention: Device: Austere shock waves device
  • Active Comparator: Sophisticated shock waves device
    3 sessions were applied: one per week.
    Intervention: Device: Sophisticated shock waves device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 17, 2015)
135
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age greater than 18 years.
  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:

  1. Bilateral plantar fasciitis.
  2. Hiper/ hypothyroidism.
  3. Diabetes mellitus.
  4. Treatment with anticoagulants
  5. Inflammatory diseases.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02608723
Other Study ID Numbers  ICMJE 1304
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Asociacion Colaboracion Cochrane Iberoamericana
Study Sponsor  ICMJE Asociacion Colaboracion Cochrane Iberoamericana
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Antoni Morral, PhDc Rehabilitation Center "Salut i Esport"
PRS Account Asociacion Colaboracion Cochrane Iberoamericana
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP