Ultrasound-guided Pulsed Radiofrequency for Plantar Fasciitis
2 other identifiers
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 10, 2014
CompletedFirst Posted
Study publicly available on registry
September 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedDecember 1, 2016
November 1, 2016
2.3 years
September 10, 2014
November 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline , 4th, 8th and 12th weeks after treatment.
Secondary Outcomes (2)
Change from baseline of functional improvement on 4th, 8th and 12th 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.
Baseline , 4th, 8th and 12th weeks after treatment.
Study Arms (2)
pulsed mode radiofrequency
ACTIVE COMPARATORPulsed 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
PLACEBO COMPARATOR2 c.c xylocaine was given in tibial nerve behind the medial ankle in control group.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Cancer of any site
- Coagulopathy
- Pregnancy
- Inflammation status
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yung-Tsan Wulead
Study Sites (1)
Tri-Service General Hospital, School of Medicine, National Defense Medical Center
Taipei, Neihu District, 886, Taiwan
Related Publications (6)
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.
PMID: 17305676BACKGROUNDVan 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.
PMID: 17055165BACKGROUNDRohof OJ. Radiofrequency treatment of peripheral nerves. Pain Pract. 2002 Sep;2(3):257-60. doi: 10.1046/j.1533-2500.2002.02033.x.
PMID: 17147740BACKGROUNDThapa 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.
PMID: 24963184RESULTErken 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.
PMID: 24165571RESULTSean 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.
PMID: 21047605RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Liang-Cheng Chen, MD, MS
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, National Defense Medical Center,
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Attending Physician
Study Record Dates
First Submitted
September 10, 2014
First Posted
September 17, 2014
Study Start
April 1, 2014
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
December 1, 2016
Record last verified: 2016-11