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Change and Clinical Significance of Plantar Fascia Thickness After ESWT

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00155324
First Posted: September 12, 2005
Last Update Posted: December 3, 2012
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.
Information provided by:
National Taiwan University Hospital
  Purpose
The aim of the study is to investigate the effect of extracorporeal shock wave therapy (ESWT) on the thickness of plantar fascia measured by ultrasonographic examination among patients with chronic plantar fascitis. The change of plantar fascia thickness will be correlated with clinical improvement.

Condition Intervention
Plantar Fasciitis Device: Extracorporeal Shock Wave Therapy (Device)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Change and Clinical Significance of Plantar Fascia Thickness After Extracorporeal Shock Wave Therapy

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Thickness of plantar fascia by ultrasonographic examination at 3 & 6 months

Secondary Outcome Measures:
  • Pain (visual analogue scale) at 3 & 6 months
  • Foot function index at 3 & 6 months
  • Short Form-36 at 3 & 6 months

Estimated Enrollment: 60
Study Start Date: October 2004
Study Completion Date: July 2006
Detailed Description:
The aim of the study is to investigate the effect of extracorporeal shock wave therapy (ESWT) on the thickness of plantar fascia measured by ultrasonographic examination among patients with chronic plantar fascitis. Two different dosage of ESWT will be applied, and the outcome will be followed 3 and 6 months after the treatment. The change of plantar fascia thickness will be correlated with clinical improvement, including the pain improvement, foot function, and quality of life at follow up.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosed as plantar fasciitis for at least 6 months
  • refractory to other conservative treatments

Exclusion Criteria:

  • Acute infection of soft tissue/bone
  • Malignancy
  • Epiphysiolysis in the focus
  • Blood coagulation disorders
  • Pregnancy
  • Patients with pacemaker
  • Foot deformity
  • Autoimmune disorders-related arthropahy
  • Sciatica
  • Previous treatment with ESWT
  Contacts and Locations
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): NCT00155324


Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: H W Liang, MD National Taiwan University Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00155324     History of Changes
Other Study ID Numbers: 9361701153
First Submitted: September 8, 2005
First Posted: September 12, 2005
Last Update Posted: December 3, 2012
Last Verified: November 2012

Keywords provided by National Taiwan University Hospital:
plantar fasciitis
ultrasonographic examination

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