NCT00155324

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

December 3, 2012

Status Verified

November 1, 2012

First QC Date

September 8, 2005

Last Update Submit

November 30, 2012

Conditions

Plantar Fasciitis

Keywords

plantar fasciitisultrasonographic examination

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

  • Pain (visual analogue scale) at 3 & 6 months

  • Foot function index at 3 & 6 months

  • Short Form-36 at 3 & 6 months

Interventions

Extracorporeal Shock Wave Therapy (Device)DEVICE

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • H W Liang, MD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

October 1, 2004

Study Completion

July 1, 2006

Last Updated

December 3, 2012

Record last verified: 2012-11

Locations

TW(1)