Ultrasound-guided Pulsed Radiofrequency for Plantar Fasciitis

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Plantar Fasciitis

Intervention / Treatment
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* Device: Pulsed radiofrequency (PRF)
* Drug: Xylocaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: pulsed mode radiofrequency<br>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)<br>* 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.<br>* Other names: Neurotherm NT1000, Neurotherm Inc., USA;|
| Placebo Comparator: Xylocaine<br>2 c.c xylocaine was given in tibial nerve behind the medial ankle in control group. | Drug: Xylocaine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulsed mode radiofrequency, Plantar Fasciitis, Ultrasound-guided