Study Evaluating the Treatment of Occipital Neuralgia
|ClinicalTrials.gov Identifier: NCT01753765|
Recruitment Status : Completed
First Posted : December 20, 2012
Last Update Posted : October 21, 2015
|Condition or disease||Intervention/treatment||Phase|
|Occipital Neuralgia||Device: Device: Cryo-Touch III Study treatment at Day 0.||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Non-Randomized Unblinded Study Evaluating the Treatment of Occipital Neuralgia With the Cryo-Touch III Device|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||July 2014|
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.
- A reduction in either pain frequency or severity associated with occipital neuralgia. [ Time Frame: 1 week ]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 ]
- Analgesic use [ Time Frame: 1 day ]
- Safety Events [ Time Frame: 56 days ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01753765
|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|