A Prospective Study Evaluating the Treatment of Knee Osteoarthritis With the Cryo-Touch III Device
A proof of concept study to evaluate the feasibility of safe and effective treatment through optimization of the Cryo-Touch III device for temporary relief of pain.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective Non-Randomized Unblinded Study Evaluating the Treatment of Knee Osteoarthritis With the Cryo-Touch III Device|
- An improvement in the Visual Analog Scale (VAS) for pain at Day 7 [ Time Frame: Screening (Day -30 to Day 0), Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 30) ] [ Designated as safety issue: No ]
- Improvement (pain, stiffness, and functionality) as determined by WOMAC Scale at Day 7. [ Time Frame: Visit 2 (Day 0), Visit 3 (Day 7) ] [ Designated as safety issue: No ]A significant difference is observed as >/= 2-points
- Duration of Treatment Effect [ Time Frame: Visit 3 (Day 7), Visit 4 (Day 30), Visit 5 (Day 56) ] [ Designated as safety issue: No ]
- Analgesic Use [ Time Frame: Screening thru Visit 5 (Day 56) ] [ Designated as safety issue: No ]
|Study Start Date:||September 2012|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Treatment with Cryo-Touch III Device
Device: Cryo-Touch III
Study treatment at Day 0.
Over 100 million patients in the United States suffer from chronic pain. Chronic pain conditions are often debilitating, taking a toll on a patient's physical and mental welfare. Though a variety of pain management techniques currently exist, the most common nonsurgical options provide slow-acting and/or short-term relief. Medication, often in the form of non-steroidal anti-inflammatory drugs (NSAIDs) and opioids, comes with an array of side effects such as nausea and vomiting. Medication also presents the possibility of more serious effects such as increased risk of heart attack and stroke, and tolerance or dependency issues. Surgical strategies tend to be reserved for more severe cases and are limited by the risks and complications typically associated with surgery including bleeding, bruising, scarring, and infection. A nonsurgical, minimally invasive, long-lasting approach to chronic pain management is desirable.
The Cryo-Touch III is a pain management device developed for a novel, minimally invasive procedure using focused cold therapy to target sensory nerve tissue and offer long-lasting pain relief through cryoanalgesia. The device operates on the well-established cryobiology principle that localized exposure to controlled moderately low temperature conditions can alter tissue function. The therapy treats nerves with low temperatures via a cold probe in the form of an assembly of small diameter needles, creating a highly localized treatment zone around the probe. This focused cold therapy creates a conduction block that prevents nerve signaling.
Though studies have proven efficacious in targeting motor nerves, the device's effect on sensory nerves has yet to have been investigated in the clinical setting. The goal of the study described herein is to evaluate the degree and duration of effect of the Cryo-Touch III in reducing chronic pain by targeting sensory nerves.