Ultrasound-guided Pulsed Radiofrequency for Plantar Fasciitis

Plantar Fasciitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02242513
• Other study ID #: TSGHIRB-2-102-05-95
• Secondary ID: TSGH-C103-115
• Status: Completed
• Phase: N/A
• First received: September 10, 2014
• Last updated: November 30, 2016
• Start date: April 2014
• Est. completion date: July 2016

Study information

• Verified date: November 2016
• Source: Tri-Service General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis

Intervention

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.

Drug:
• Xylocaine

Locations

Country	Name	City	State
Taiwan	Tri-Service General Hospital, School of Medicine, National Defense Medical Center	Taipei	Neihu District

Sponsors (1)

Lead Sponsor	Collaborator
Yung-Tsan Wu

Country where clinical trial is conducted

Taiwan, 

References & Publications (6)

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. — View 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. — View Citation

Rohof OJ. Radiofrequency treatment of peripheral nerves. Pain Pract. 2002 Sep;2(3):257-60. — View 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. — View 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. — View Citation

Van Zundert J, Patijn J, Kessels A, Lamé 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	Baseline , 4th, 8th and 12th weeks after treatment.	No
Secondary	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.	Baseline , 4th, 8th and 12th weeks after treatment.	No