Status:
COMPLETED
Plantar Fasciosis Treatment Using Coblation
Lead Sponsor:
ArthroCare Corporation
Conditions:
Plantar Fasciitis
Eligibility:
All Genders
18-72 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the effectiveness of Coblation-based fasciotomy for relieving pain associated with recurring plantar fasciosis and, secondarily, to determine whether there may...
Detailed Description
Severe recalcitrant heel pain, resulting from repetitive trauma to the plantar fascia, is a relatively commonly observed phenomenon. Although this condition is frequently referred to as 'heel spurs', ...
Eligibility Criteria
Inclusion
- Diagnosis of plantar fasciitis/fasciosis by all of the following:
- Tenderness with palpation and local pressure over the medial calcaneal tuberosity on passive dorsiflexion of the foot
- VAS (Visual Analog Scale) pain score of \> 5 points on a scale of 0 to 10, during the first few minutes of walking in the morning
- Ultrasound or magnetic resonance imaging (MRI) confirming plantar fasciitis/fasciosis
- Symptoms consistent with plantar fasciitis/fasciosis for at least 6 months as assessed by patient history
- Pain unresponsive to non-steroidal anti-inflammatory drugs (NSAIDs) and any four of the following conservative treatments: rest, taping, orthotics, shoe modifications, night splinting, casting, physical therapy, or local corticosteroid injections for up to 3 months
- Must be at least 18 years old and no more than 72 years old
- Must sign the Institutional Review Board (IRB) approved informed consent form
- Subject is willing and able to complete required follow-up
Exclusion
- Body mass index (BMI) \> 40
- History or documentation showing type I and type II diabetes mellitus
- Physical findings and documentation of coagulopathy, infection, tumor or other systemic disease(s)
- History or documentation showing peripheral vascular disease or autoimmune disease
- Subject has received NSAIDs (e.g., ibuprofen, naproxen) for treatment of plantar fasciitis/fasciosis 2 weeks prior to treatment by this study
- Subject has received NSAIDs (e.g. ibuprofen, naproxen) or oral corticosteroids 2 weeks prior to treatment by this study
- Subject is receiving worker's compensation
- Subject is currently involved in litigation related to the injury being studied
- Prior surgical treatment of the plantar fascia(s) to be treated by this study
- Subject is currently participating in another drug/device study related to the injured plantar fascia
- Pregnant or pregnant suspected subjects
- Clinically significant bilateral plantar fasciitis/fasciosis with a VAS pain scale of \> 5 bilaterally
- Subject is not capable of understanding or responding to study questionnaires.
- Extracorporeal shockwave therapy (ESWT) within 6 months of study treatment
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00189592
Start Date
August 1 2005
End Date
June 1 2008
Last Update
August 26 2015
Active Locations (1)
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1
Weil Foot & Ankle Institute
Des Plaines, Illinois, United States, 60016