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Ultrasound-guided Pulsed Radiofrequency for Plantar Fasciitis

Primary Purpose

Plantar Fasciitis

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Pulsed radiofrequency (PRF)
Xylocaine
Sponsored by
Yung-Tsan Wu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fasciitis focused on measuring Pulsed mode radiofrequency, Plantar Fasciitis, Ultrasound-guided

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tri-Service General Hospital, School of Medicine, National Defense Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

pulsed mode radiofrequency

Xylocaine

Arm Description

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.

2 c.c xylocaine was given in tibial nerve behind the medial ankle in control group.

Outcomes

Primary Outcome Measures

Change from baseline of pain on 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

Change from baseline of functional improvement on 4th, 8th and 12th 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.
Using the musculoskeletal ultrasonography to measure the thickness before treatment and multiple time frame after treatment.

Full Information

First Posted
September 10, 2014
Last Updated
November 30, 2016
Sponsor
Yung-Tsan Wu
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1. Study Identification

Unique Protocol Identification Number
NCT02242513
Brief Title
Ultrasound-guided Pulsed Radiofrequency for Plantar Fasciitis
Official Title
Ultrasound-guided Pulsed Radiofrequency Stimulation of the Tibial Nerve for Plantar Fasciitis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yung-Tsan Wu

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fasciitis
Keywords
Pulsed mode radiofrequency, Plantar Fasciitis, Ultrasound-guided

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pulsed mode radiofrequency
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Xylocaine
Arm Type
Placebo Comparator
Arm Description
2 c.c xylocaine was given in tibial nerve behind the medial ankle in control group.
Intervention Type
Device
Intervention Name(s)
Pulsed radiofrequency (PRF)
Other Intervention Name(s)
Neurotherm NT1000, Neurotherm Inc., USA
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Xylocaine
Primary Outcome Measure Information:
Title
Change from baseline of pain on 4th, 8th and 12th weeks after treatment.
Description
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.
Time Frame
Baseline , 4th, 8th and 12th weeks after treatment.
Secondary Outcome Measure Information:
Title
Change from baseline of functional improvement on 4th, 8th and 12th after treatment.
Description
Using the functional subscore of foot health status questionnaire to measure the functional socre before treatment and multiple time frame after treatment.
Time Frame
Baseline , 4th, 8th and 12th weeks after treatment.
Title
Change from baseline of thickness of plantar fascile on 4th, 8th and 12th weeks after treatment.
Description
Using the musculoskeletal ultrasonography to measure the thickness before treatment and multiple time frame after treatment.
Time Frame
Baseline , 4th, 8th and 12th weeks after treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liang-Cheng Chen, MD, MS
Organizational Affiliation
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, National Defense Medical Center,
Official's Role
Study Director
Facility Information:
Facility Name
Tri-Service General Hospital, School of Medicine, National Defense Medical Center
City
Taipei
State/Province
Neihu District
ZIP/Postal Code
886
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
17305676
Citation
Martin DC, Willis ML, Mullinax LA, Clarke NL, Homburger JA, Berger IH. Pulsed radiofrequency application in the treatment of chronic pain. Pain Pract. 2007 Mar;7(1):31-5. doi: 10.1111/j.1533-2500.2007.00107.x.
Results Reference
background
PubMed Identifier
17055165
Citation
Van Zundert J, Patijn J, Kessels A, Lame I, van Suijlekom H, van Kleef M. Pulsed radiofrequency adjacent to the cervical dorsal root ganglion in chronic cervical radicular pain: a double blind sham controlled randomized clinical trial. Pain. 2007 Jan;127(1-2):173-82. doi: 10.1016/j.pain.2006.09.002. Epub 2006 Oct 18.
Results Reference
background
PubMed Identifier
17147740
Citation
Rohof OJ. Radiofrequency treatment of peripheral nerves. Pain Pract. 2002 Sep;2(3):257-60. doi: 10.1046/j.1533-2500.2002.02033.x.
Results Reference
background
PubMed Identifier
24963184
Citation
Thapa D, Ahuja V. Combination of diagnostic medial calcaneal nerve block followed by pulsed radiofrequency for plantar fascitis pain: A new modality. Indian J Anaesth. 2014 Mar;58(2):183-5. doi: 10.4103/0019-5049.130824.
Results Reference
result
PubMed Identifier
24165571
Citation
Erken HY, Ayanoglu S, Akmaz I, Erler K, Kiral A. Prospective study of percutaneous radiofrequency nerve ablation for chronic plantar fasciitis. Foot Ankle Int. 2014 Feb;35(2):95-103. doi: 10.1177/1071100713509803. Epub 2013 Oct 28.
Results Reference
result
PubMed Identifier
21047605
Citation
Sean NY, Singh I, Wai CK. Radiofrequency microtenotomy for the treatment of plantar fasciitis shows good early results. Foot Ankle Surg. 2010 Dec;16(4):174-7. doi: 10.1016/j.fas.2009.10.008. Epub 2009 Nov 25.
Results Reference
result

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Ultrasound-guided Pulsed Radiofrequency for Plantar Fasciitis

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