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

Chronic Plantar Fasciitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01981226
• Other study ID #: 201007055R
• Status: Recruiting
• Phase: N/A
• First received: November 5, 2013
• Last updated: November 8, 2013
• Start date: September 2010

Study information

• Verified date: November 2013
• Source: National Taiwan University Hospital
• Contact: Yun-Yi Lin, M.D.
• Phone: +886972653424
• Email: doc9775c[@]yahoo.com.tw
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Plantar Fasciitis
• Fasciitis
• Fasciitis, Plantar

Intervention

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

Locations

Country	Name	City	State
Taiwan	Natinal Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain intensity(VAS scale)		pre-treatment, 1 week, 1 month, 3 month, 6 month, 9 month, 12 month	No
Primary	Sonoelastographic changes of plantar fascia after ESWT		pre-treatment, 1 week, 1 month, 3 month, 6 month, 9 month, 12 month	No
Secondary	Plantar fascia thickness		pre-treatment, 1 week, 1 month, 3 month, 6 month, 9 month, 12 month	No