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

Not Applicable

• Conditions: Chronic Plantar Fasciitis
• Interventions: Device: Extracoporeal shock wave

• Registration Number: NCT01981226
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study Start: 2010-09
• Status Verified: 2013-11
• Study First Submitted: 2013-11-05
• Study First Submitted QC: 2013-11-08
• Last Update Submitted: 2013-11-08
• Study First Posted: 2013-11-11
• Last Update Posted: 2013-11-11
• Primary Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Extracoporeal shock wave	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

Primary Outcome Measures

Name	Time	Method
Sonoelastographic changes of plantar fascia after ESWT	pre-treatment, 1 week, 1 month, 3 month, 6 month, 9 month, 12 month

Secondary Outcome Measures

Name	Time	Method
Plantar fascia thickness	pre-treatment, 1 week, 1 month, 3 month, 6 month, 9 month, 12 month

Trial Locations

Locations (1)

Natinal Taiwan University Hospital; 🇨🇳 Taipei, Taiwan