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Change and Clinical Significance of Plantar Fascia Thickness After ESWT

Primary Purpose

Plantar Fasciitis

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Extracorporeal Shock Wave Therapy (Device)
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fasciitis focused on measuring plantar fasciitis, ultrasonographic examination

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University Hospital

Outcomes

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

Full Information

First Posted
September 8, 2005
Last Updated
November 30, 2012
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00155324
Brief Title
Change and Clinical Significance of Plantar Fascia Thickness After ESWT
Official Title
Change and Clinical Significance of Plantar Fascia Thickness After Extracorporeal Shock Wave Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Taiwan University Hospital

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fasciitis
Keywords
plantar fasciitis, ultrasonographic examination

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Extracorporeal Shock Wave Therapy (Device)
Primary Outcome Measure Information:
Title
Thickness of plantar fascia by ultrasonographic examination at 3 & 6 months
Secondary Outcome Measure Information:
Title
Pain (visual analogue scale) at 3 & 6 months
Title
Foot function index at 3 & 6 months
Title
Short Form-36 at 3 & 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H W Liang, MD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

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Change and Clinical Significance of Plantar Fascia Thickness After ESWT

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