Ultrasound-guided Pulsed Radiofrequency for Plantar Fasciitis

November 30, 2016 updated by: Yung-Tsan Wu

Ultrasound-guided Pulsed Radiofrequency Stimulation of the Tibial Nerve for Plantar Fasciitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Neihu District
      • Taipei, Neihu District, Taiwan, 886
        • Tri-Service General Hospital, School of Medicine, National Defense Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: pulsed mode radiofrequency
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.
Device: 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.
Other Names:
  • Neurotherm NT1000, Neurotherm Inc., USA
Placebo Comparator: Xylocaine
2 c.c xylocaine was given in tibial nerve behind the medial ankle in control group.
Drug: Xylocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of pain on 4th, 8th and 12th weeks after treatment.
Time Frame: 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.
Baseline , 4th, 8th and 12th weeks after treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of functional improvement on 4th, 8th and 12th after treatment.
Time Frame: 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.
Baseline , 4th, 8th and 12th weeks after treatment.
Change from baseline of thickness of plantar fascile on 4th, 8th and 12th weeks after treatment.
Time Frame: Baseline , 4th, 8th and 12th weeks after treatment.
Using the musculoskeletal ultrasonography to measure the thickness before treatment and multiple time frame after treatment.
Baseline , 4th, 8th and 12th weeks after treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yung-Tsan Wu

Investigators

  • Study Director: Liang-Cheng Chen, MD, MS, Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, National Defense Medical Center,

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

September 10, 2014

First Submitted That Met QC Criteria

September 16, 2014

First Posted (Estimate)

September 17, 2014

Study Record Updates

Last Update Posted (Estimate)

December 1, 2016

Last Update Submitted That Met QC Criteria

November 30, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSGHIRB-2-102-05-95
  • TSGH-C103-115 (Other Grant/Funding Number: TSGH-C103-115)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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