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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01981226
Collaborator
(none)
30
Enrollment
1
Location
1
Arm

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Extracoporeal shock wave
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Sonoelastographic Changes After Low Energy Extracorporeal Shock Wave Therapy (ESWT) in Plantar Fasciitis
Study Start Date :
Sep 1, 2010
Anticipated Primary Completion Date :
Sep 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Extracoporeal shock wave

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
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

Outcome Measures

Primary Outcome Measures

  1. Sonoelastographic changes of plantar fascia after ESWT [pre-treatment, 1 week, 1 month, 3 month, 6 month, 9 month, 12 month]

Secondary Outcome Measures

  1. Plantar fascia thickness [pre-treatment, 1 week, 1 month, 3 month, 6 month, 9 month, 12 month]

Other Outcome Measures

  1. Pain intensity(VAS scale) [pre-treatment, 1 week, 1 month, 3 month, 6 month, 9 month, 12 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Natinal Taiwan University Hospital Taipei Taiwan 100

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital, Sonoelastographic Changes After Low Energy Extracorporeal Shock Wave Therapy (ESWT) in Plantar Fasciitis, National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01981226
Other Study ID Numbers:
  • 201007055R
First Posted:
Nov 11, 2013
Last Update Posted:
Nov 11, 2013
Last Verified:
Nov 1, 2013
Additional relevant MeSH terms:
Fasciitis
Fasciitis, Plantar

Study Results

No Results Posted as of Nov 11, 2013