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NCT Number: NCT02242513

Ultrasound-guided Pulsed Radiofrequency 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.

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Key information

Conditions

Plantar Fasciitis Fasciitis Fasciitis, Plantar Foot Diseases Musculoskeletal Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Taipei, Neihu District, 886, Taiwan

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulsed radiofrequency (PRF)

Device

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

Xylocaine

Drug

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Yung-Tsan Wu

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 17, 2014
Registry last updated
Dec 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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