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Sonoelastographic Changes After Low Energy Extracorporeal Shock Wave Therapy (ESWT) in Plantar Fasciitis

Primary Purpose

Chronic Plantar Fasciitis

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Extracoporeal shock wave
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Plantar Fasciitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Natinal Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Extracoporeal shock wave

Arm Description

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

Outcomes

Primary Outcome Measures

Sonoelastographic changes of plantar fascia after ESWT

Secondary Outcome Measures

Plantar fascia thickness

Full Information

First Posted
November 5, 2013
Last Updated
November 8, 2013
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01981226
Brief Title
Sonoelastographic Changes After Low Energy Extracorporeal Shock Wave Therapy (ESWT) in Plantar Fasciitis
Official Title
Sonoelastographic Changes After Low Energy Extracorporeal Shock Wave Therapy (ESWT) in Plantar Fasciitis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

5. Study Description

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.
Detailed Description
For patient who met the inclusion criteria, we check sonography and sonoelastography for their plantar fascias and obtain a thorough evulation questionaire for clinical symptom and pain condition and intensity in various conditions, also SF-36 questionaire first. Inform consent was done. After the ESWT, we follow patient with questionaire and sonography/sonoelastography at 1-week, 1-month, 3-month, 6-month, 9-month, and 12-month post-ESWT time. The colored sonoelastographic image was analysed by computer software "Image-J" with hue analysis method and relative stiffness of selected area within proximal plantar fascia wasa obtained for statistical analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Plantar Fasciitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Extracoporeal shock wave
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Extracoporeal shock wave
Intervention Description
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
Primary Outcome Measure Information:
Title
Sonoelastographic changes of plantar fascia after ESWT
Time Frame
pre-treatment, 1 week, 1 month, 3 month, 6 month, 9 month, 12 month
Secondary Outcome Measure Information:
Title
Plantar fascia thickness
Time Frame
pre-treatment, 1 week, 1 month, 3 month, 6 month, 9 month, 12 month
Other Pre-specified Outcome Measures:
Title
Pain intensity(VAS scale)
Time Frame
pre-treatment, 1 week, 1 month, 3 month, 6 month, 9 month, 12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: pain for more than 6 months，poor response to the conservative treatments Sonography showed plantar fasciitia>4.0mm) Exclusion Criteria: Acute infection of soft tissue/bone Malignant primary disease Blood coagulation disorders Pregnancy Patients with pacemaker foot deformity
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yun-Yi Lin, M.D.
Phone
+886972653424
Email
doc9775c@yahoo.com.tw
Facility Information:
Facility Name
Natinal Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yun-yi Lin, M.D.
Phone
+886972655935
Email
doc9775c@yahoo.com.tw

12. IPD Sharing Statement

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Sonoelastographic Changes After Low Energy Extracorporeal Shock Wave Therapy (ESWT) in Plantar Fasciitis

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