Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT01753765 |
Other study ID # |
MYO-0613 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 2012 |
Est. completion date |
July 2014 |
Study information
Verified date |
January 2024 |
Source |
Pacira Pharmaceuticals, Inc |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.