NCT01981226

Brief Summary

Extracoporeal shock wave therapy(ESWT) was perfomed on the plantar fascia of chornic plantar fasciitis patients. Pre-ESWT and post-ESWT pain intensity, sonography and sonoelastrography of the plantar fascia was checked. Our hypothesis is that the plantar fascia stiffness increased after ESWT as clinical symptom improves.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

November 5, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 11, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Last Updated

November 11, 2013

Status Verified

November 1, 2013

Enrollment Period

5 years

First QC Date

November 5, 2013

Last Update Submit

November 8, 2013

Conditions

Chronic Plantar Fasciitis

Outcome Measures

Primary Outcomes (1)

  • Sonoelastographic changes of plantar fascia after ESWT

    pre-treatment, 1 week, 1 month, 3 month, 6 month, 9 month, 12 month

Secondary Outcomes (1)

  • Plantar fascia thickness

    pre-treatment, 1 week, 1 month, 3 month, 6 month, 9 month, 12 month

Other Outcomes (1)

  • Pain intensity(VAS scale)

    pre-treatment, 1 week, 1 month, 3 month, 6 month, 9 month, 12 month

Study Arms (1)

Extracoporeal shock wave

EXPERIMENTAL

Extracoporeal shock wave, 3000 shots/time, once a week for 3 weeks, treatment duration:30 minutes/time, shock wave freqency：2-4Hz, energy level:0.8-1.0 mJ/mm2

Device: Extracoporeal shock wave

Interventions

Extracoporeal shock waveDEVICE

Extracoporeal shock wave, 3000 shots/time, once a week for 3 weeks, treatment duration:30 minutes/time, shock wave freqency：2-4Hz, energy level:0.8-1.0 mJ/mm2

Extracoporeal shock wave

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pain for more than 6 months，poor response to the conservative treatments
  • Sonography showed plantar fasciitia\>4.0mm)

You may not qualify if:

  • Acute infection of soft tissue/bone
  • Malignant primary disease
  • Blood coagulation disorders
  • Pregnancy
  • Patients with pacemaker
  • foot deformity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Natinal Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Central Study Contacts

Yun-Yi Lin, M.D.

CONTACT

+886972653424doc9775c@yahoo.com.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sonoelastographic Changes After Low Energy Extracorporeal Shock Wave Therapy (ESWT) in Plantar Fasciitis

Study Record Dates

First Submitted

November 5, 2013

First Posted

November 11, 2013

Study Start

September 1, 2010

Primary Completion

September 1, 2015

Last Updated

November 11, 2013

Record last verified: 2013-11

Locations

TW(1)