Plantar Fasciosis Treatment Using Coblation
Completed · Phase 4
Conditions studied: Plantar Fasciitis
In brief
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 be additional potential benefits stemming from its use.
Key facts
- Study ID
- NCT00189592
- Run by
- ArthroCare Corporation
- People needed
- 45
- Starts
- 2005-08-01
- Expected to finish
- 2008-06-01
- Last updated by the study team
- 2015-08-26
Who can join
Age: 18 and older, up to 72. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Weil Foot & Ankle Institute — Des Plaines, Illinois, United States
Full record on ClinicalTrials.gov
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