Study Evaluating the Treatment of Occipital Neuralgia
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 or reduction in pain due to occipital neuralgia.
|Study Design:||Endpoint Classification: Safety/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 Occipital Neuralgia With the Cryo-Touch III Device|
- A reduction in either pain frequency or severity associated with occipital neuralgia. [ Time Frame: 1 week ] [ Designated as safety issue: No ]Improvement of pain due to occipital neuralgia as measured on the Visual Analog Scale (VAS) for pain at Day 7 as compared to baseline (Day 0).
- Duration of treatment [ Time Frame: 56 days ] [ Designated as safety issue: No ]
- Analgesic use [ Time Frame: 1 day ] [ Designated as safety issue: No ]
- Safety Events [ Time Frame: 56 days ] [ Designated as safety issue: Yes ]Adverse events and SAEs/UADEs will be assessed at all visits. Incidence of serious adverse events (SAEs) and unanticipated adverse device effects (UADEs) will be recorded. A serious adverse event is one that meets the ISO definition of SAE
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||April 2014|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Study treatment with Cryo-Touch III device at Day 0.
Device: Device: Cryo-Touch III Study treatment at Day 0.
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.
Myoscience, Inc. (Redwood City, CA) has developed a pain management device - the Cryo-Touch III - 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 via a probe in the form of an assembly of small diameter needles, creating a highly localized, low temperature treatment zone around the probe. This focused cold therapy creates a conduction block that prevents nerve signaling. Prior studies of the Cryo-Touch, Cryo-Touch II, Cryo-Touch III (a.k.a. PCP 1.0) devices have provided preliminary evidence of effectiveness on motor nerves and have been shown to be safe with no serious device-related adverse events.
Though studies have proven efficacious in targeting motor nerves, the device's effect on sensory nerves has yet to be 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.
|United States, California|
|Napa, California, United States, 94557|
|United States, Idaho|
|Injury Care Medical Center|
|Boise, Idaho, United States, 83713|
|United States, Kansas|
|International Clinical Research|
|Overland Park, Kansas, United States, 66210|