Change and Clinical Significance of Plantar Fascia Thickn... | NCT00155324

Studies
Change and Clinical Significance of Plantar Fascia Thickness After ESWT

NCT00155324

Sponsor

National Taiwan University Hospital

Status

Completed

Last Update Posted

Dec 3, 2012Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Plantar Fasciitis

Interventions

Extracorporeal Shock Wave Therapy (Device)

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2004

Primary Completion Date

Not provided

Completion Date

Jul 2006Actual

First Submitted Date

Sep 8, 2005

First Submission Date that Met QC Criteria

Sep 8, 2005

First Posted Date

Sep 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2012

Last Update Posted Date

Dec 3, 2012Estimated

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Name	Type	Description	Arm Group Labels	Other Names
Extracorporeal Shock Wave Therapy (Device)	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Thickness of plantar fascia by ultrasonographic examination at 3 & 6 months

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
H W Liang, MD	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital		Taipei		100	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D036981	Fasciitis, Plantar

Ancestor Terms

ID	Term
D005208	Fasciitis
D009140	Musculoskeletal Diseases
D005534	Foot Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000074059	Extracorporeal Shockwave Therapy

Ancestor Terms

ID	Term
D014464	Ultrasonic Therapy
D003972	Diathermy
D006979	Hyperthermia, Induced
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided