Ultrasound-guided Pulsed Radiofrequency for Plantar Fasciitis

Not Applicable

Completed

• Conditions: Plantar Fasciitis
• Interventions: Device: Pulsed radiofrequency (PRF); Drug: Xylocaine

• Registration Number: NCT02242513
• Lead Sponsor: Yung-Tsan Wu

Brief Summary

Although there are many conservative method for plantar fasciitis, patients might spend 2 years to achieve resolution. Recent study have shown that pulsed radiofrequency (PRF) lesioning of peripheral nerve can alleviate kinds of pain condition. However there are no studies of PRF lesioning of the tibial nerve in patients with plantar fascilitis by using ultrasound-guided (UG) techniques.

Detailed Description

Patients with unilateral plantar Fasciitis will be enrolled and randomized into intervention and control group. One dose of sono-guided PRF is applied in the intervention group and xylocaine in control group. Outcome measurements included visual analog scale (VAS)、foot health status questionnaire and the thickness of plantar fascile measured by musculoskeletal ultrasonography at different follow-up frame (4th week, 2nd month, 3rd month after treatment).

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-09-10
• Study First Submitted QC: 2014-09-16
• Study First Posted: 2014-09-17
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-30
• Last Update Posted: 2016-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Heel pain more than 3 months
• Age more than 20 year-old
• The increased thickness of plantar fascile (>4mm) measured by sonography
• Must be conscious
• Not receive steroid or other injection in plantar fascile in past 6 months

Exclusion Criteria

• Cancer of any site
• Coagulopathy
• Pregnancy
• Inflammation status

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pulsed mode radiofrequency	Pulsed radiofrequency (PRF)	Pulsed radiofrequency (PRF) treatment, a relative novel pain intervention at recent decade, was found to be able to alleviate pain by delivering an electrical field and heat bursts at a temperature less than 42°C to neural tissue in the absence of neural injury. One dose of PRF was given in tibial nerve behine the medial ankle in intervention group.
Xylocaine	Xylocaine	2 c.c xylocaine was given in tibial nerve behind the medial ankle in control group.

Primary Outcome Measures

Name	Time	Method
Change from baseline of pain on 4th, 8th and 12th weeks after treatment.	Baseline , 4th, 8th and 12th weeks after treatment.	Using the Visual analog scale (VAS) and subscore of foot health status questionnaire to measure the pain scale before treatment and multiple time frame after treatment.

Secondary Outcome Measures

Name	Time	Method
Change from baseline of functional improvement on 4th, 8th and 12th after treatment.	Baseline , 4th, 8th and 12th weeks after treatment.	Using the functional subscore of foot health status questionnaire to measure the functional socre before treatment and multiple time frame after treatment.
Change from baseline of thickness of plantar fascile on 4th, 8th and 12th weeks after treatment.	Baseline , 4th, 8th and 12th weeks after treatment.	Using the musculoskeletal ultrasonography to measure the thickness before treatment and multiple time frame after treatment.

Trial Locations

Locations (1)

Tri-Service General Hospital, School of Medicine, National Defense Medical Center; 🇨🇳 Taipei, Neihu District, Taiwan