Entrapment Neuropathy Clinical Trial
Official title:
A Prospective Non-Randomized Unblinded Study Evaluating Treatment of Forefoot Pain Related to Nerve Entrapment Using 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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT06400433 -
Comparing Efficacies of Median Nerve Hydrodissection With Dexamethasone and Dextrose in Carpal Tunnel Syndrome
|
N/A | |
| Completed |
NCT04949373 -
High Intensity Laser Therapy in Carpal Tunnel Syndrome
|
N/A | |
| Completed |
NCT02318381 -
Suprascapular Neuropathy in the Setting of Rotator Cuff Tears: Results of Arthroscopic Treatment
|
N/A | |
| Completed |
NCT03062722 -
Efficacy of Keyhole Approach to Carpal Tunnel Syndrome Under Ambulatory Strategy
|
N/A |