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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01981226
First received: November 5, 2013
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

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 Intervention
Chronic Plantar Fasciitis
Device: Extracoporeal shock wave

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sonoelastographic Changes After Low Energy Extracorporeal Shock Wave Therapy (ESWT) in Plantar Fasciitis

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Sonoelastographic changes of plantar fascia after ESWT [ Time Frame: pre-treatment, 1 week, 1 month, 3 month, 6 month, 9 month, 12 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plantar fascia thickness [ Time Frame: pre-treatment, 1 week, 1 month, 3 month, 6 month, 9 month, 12 month ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Pain intensity(VAS scale) [ Time Frame: pre-treatment, 1 week, 1 month, 3 month, 6 month, 9 month, 12 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2010
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: November 5, 2013
Last Updated: November 8, 2013
Health Authority: Taiwan: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 01, 2014