Clinical trial NCT02242513: Ultrasound-guided Pulsed Radiofrequency for Plantar Fasciitis
Official title: Ultrasound-guided Pulsed Radiofrequency Stimulation of the Tibial Nerve for Plantar Fasciitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plantar Fasciitis
Keywords: Pulsed mode radiofrequency
Plantar Fasciitis
Ultrasound-guided
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2014-09-17
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Change from baseline of pain on 4th, 8th and 12th weeks after treatment.
timeFrame: Baseline , 4th, 8th and 12th weeks after treatment.
Secondary outcomes:
measure: Change from baseline of functional improvement on 4th, 8th and 12th after treatment.
timeFrame: Baseline , 4th, 8th and 12th weeks after treatment.
measure: Change from baseline of thickness of plantar fascile on 4th, 8th and 12th weeks after treatment.
timeFrame: Baseline , 4th, 8th and 12th weeks after treatment.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital, School of Medicine, National Defense Medical Center
state: Neihu District
Study officials:
affiliation: Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, National Defense Medical Center,
name: Liang-Cheng Chen, MD, MS
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.