Change and Clinical Significance of Plantar Fascia Thickness After ESWT

Plantar Fasciitis Clinical Trial

Official title:

Change and Clinical Significance of Plantar Fascia Thickness After Extracorporeal Shock Wave Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00155324
• Other study ID #: 9361701153
• Status: Completed
• Phase: N/A
• First received: September 8, 2005
• Last updated: November 30, 2012
• Start date: October 2004
• Est. completion date: July 2006

Study information

• Verified date: November 2012
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis

Intervention

Device:
• Extracorporeal Shock Wave Therapy (Device)

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thickness of plantar fascia by ultrasonographic examination at 3 & 6 months
Secondary	Pain (visual analogue scale) at 3 & 6 months
Secondary	Foot function index at 3 & 6 months
Secondary	Short Form-36 at 3 & 6 months