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Change and Clinical Significance of Plantar Fascia Thickness After ESWT

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00155324
First received: September 8, 2005
Last updated: November 30, 2012
Last verified: November 2012
History of Changes
  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-Blind
Primary Purpose: Treatment
Official Title: Change and Clinical Significance of Plantar Fascia Thickness After Extracorporeal Shock Wave Therapy

Resource links provided by NLM:

MedlinePlus related topics: Shock
U.S. FDA Resources

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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00155324     History of Changes
Other Study ID Numbers: 9361701153
Study First Received: September 8, 2005
Last Updated: November 30, 2012
Health Authority: Taiwan: Department of Health

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

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

ClinicalTrials.gov processed this record on May 21, 2013