Extracorporeal Shock Wave Therapy (Device) in Plantar Fasciitis - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Plantar Fasciitis

Intervention / Treatment

Device: Extracorporeal Shock Wave Therapy (Device)

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Taiwan
- - Taipei, Taiwan, 100
    - National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Thickness of plantar fascia by ultrasonographic examination at 3 & 6 months

Secondary Outcome Measures

Outcome Measure
Pain (visual analogue scale) at 3 & 6 months
Foot function index at 3 & 6 months
Short Form-36 at 3 & 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

Principal Investigator: H W Liang, MD, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Study Completion (ACTUAL)

July 1, 2006

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria