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Sonoelastographic Changes After Low Energy Extracorporeal Shock Wave Therapy (ESWT) in Plantar Fasciitis

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ClinicalTrials.gov Identifier: NCT01981226
Recruitment Status : Unknown
Verified November 2013 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : November 11, 2013
Last Update Posted : November 11, 2013
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
Extracoporeal shock wave therapy(ESWT) was perfomed on the plantar fascia of chornic plantar fasciitis patients. Pre-ESWT and post-ESWT pain intensity, sonography and sonoelastrography of the plantar fascia was checked. Our hypothesis is that the plantar fascia stiffness increased after ESWT as clinical symptom improves.

Condition or disease Intervention/treatment Phase
Chronic Plantar Fasciitis Device: Extracoporeal shock wave Not Applicable

Detailed Description:

For patient who met the inclusion criteria, we check sonography and sonoelastography for their plantar fascias and obtain a thorough evulation questionaire for clinical symptom and pain condition and intensity in various conditions, also SF-36 questionaire first. Inform consent was done.

After the ESWT, we follow patient with questionaire and sonography/sonoelastography at 1-week, 1-month, 3-month, 6-month, 9-month, and 12-month post-ESWT time.

The colored sonoelastographic image was analysed by computer software "Image-J" with hue analysis method and relative stiffness of selected area within proximal plantar fascia wasa obtained for statistical analysis.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sonoelastographic Changes After Low Energy Extracorporeal Shock Wave Therapy (ESWT) in Plantar Fasciitis
Study Start Date : September 2010
Estimated Primary Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Extracoporeal shock wave
Extracoporeal shock wave, 3000 shots/time, once a week for 3 weeks, treatment duration:30 minutes/time, shock wave freqency:2-4Hz, energy level:0.8-1.0 mJ/mm2
Device: Extracoporeal shock wave
Extracoporeal shock wave, 3000 shots/time, once a week for 3 weeks, treatment duration:30 minutes/time, shock wave freqency:2-4Hz, energy level:0.8-1.0 mJ/mm2



Primary Outcome Measures :
  1. Sonoelastographic changes of plantar fascia after ESWT [ Time Frame: pre-treatment, 1 week, 1 month, 3 month, 6 month, 9 month, 12 month ]

Secondary Outcome Measures :
  1. Plantar fascia thickness [ Time Frame: pre-treatment, 1 week, 1 month, 3 month, 6 month, 9 month, 12 month ]

Other Outcome Measures:
  1. Pain intensity(VAS scale) [ Time Frame: pre-treatment, 1 week, 1 month, 3 month, 6 month, 9 month, 12 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • pain for more than 6 months,poor response to the conservative treatments
  • Sonography showed plantar fasciitia>4.0mm)

Exclusion Criteria:

  • Acute infection of soft tissue/bone
  • Malignant primary disease
  • Blood coagulation disorders
  • Pregnancy
  • Patients with pacemaker
  • foot deformity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01981226


Contacts
Contact: Yun-Yi Lin, M.D. +886972653424 doc9775c@yahoo.com.tw

Locations
Taiwan
Natinal Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Yun-yi Lin, M.D.    +886972655935    doc9775c@yahoo.com.tw   
Sponsors and Collaborators
National Taiwan University Hospital

Responsible Party: National Taiwan University Hospital, Sonoelastographic Changes After Low Energy Extracorporeal Shock Wave Therapy (ESWT) in Plantar Fasciitis
ClinicalTrials.gov Identifier: NCT01981226     History of Changes
Other Study ID Numbers: 201007055R
First Posted: November 11, 2013    Key Record Dates
Last Update Posted: November 11, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases