Study Evaluating Treatment of Forefoot Pain Related to Nerve Entrapment Using the Cryo-Touch III Device

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MyoScience, Inc
ClinicalTrials.gov Identifier:
NCT01753778
First received: December 14, 2012
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Entrapment Neuropathy
Device: Cryo-Touch III Device

Study Type: Interventional
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 Treatment of Forefoot Pain Related to Nerve Entrapment Using the Cryo-Touch III Device

Resource links provided by NLM:


Further study details as provided by MyoScience, Inc:

Primary Outcome Measures:
  • Improvement of forefoot pain at day 7 [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Improvement of forefoot pain due to nerve entrapment, as measured on the Visual Analog Scale (VAS) for pain at Day 7 as compared to baseline (Day 0).


Secondary Outcome Measures:
  • Duration of Treatment [ Time Frame: 56 days ] [ Designated as safety issue: No ]
    Duration of Treatment Effect/No Effect

  • Safety Endpoints [ 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


Enrollment: 7
Study Start Date: November 2012
Study Completion Date: August 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Treatment with Cryo-Touch III Device at Day 0
Device: Cryo-Touch III Device
Treatment with Cryo-Touch III

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female, 18 years of age and older. Female subjects of childbearing potential must not be pregnant at time of treatment.
  2. Trial participants must have a confirmed diagnosis of pain in the forefoot that is due to entrapment of related nerves.
  3. Any medication must be maintained on a stable schedule for at least two weeks prior to treatment. No washout period is allowed.
  4. Must have an average score for pain of ≥ 4/10 Visual Analog Scale (VAS) over the last 7 days.
  5. Subject is willing and able to give written informed consent and able to comply with study instructions.
  6. Subject is willing and able to comply with study instructions and commit to all follow-up visits for the duration of the study.
  7. Subject is in otherwise good general health and free of any systemic disease state or physical condition that might impair evaluation or which in the investigator's opinion, exposes the subject to an unacceptable risk by study participation.

Exclusion Criteria:

  1. History of fibromyalgia, cerebrovascular accident (CVA), foot or lower limb trauma, stroke, or bone deformity.
  2. Patient who has severe pain for any reason other than forefoot pain due to nerve entrapment.
  3. Any additional diagnosis that in the opinion of the investigator directly contributes to forefoot pain.
  4. Any concomitant inflammatory disease or other condition that affects the joints (e.g. rheumatoid arthritis, metabolic bone disease, gout, active infection, etc.)
  5. Surgical invention previously conducted in the forefoot area.
  6. Any injection (neurolytic, sclerosing, anesthetic, etc.) to the foot within the last 2 months.
  7. Any use of systemic injections (in any area) for pain management within the last 4 months.
  8. Any use (i.e. oral, topical, inhaled and/or injected) of anesthetics or steroids within the last 30 days.
  9. Current enrollment in an investigational drug or a device study that specifically targets pain treatment.
  10. Enrollment in any other investigational drug or device study or participation within the last 30 days.
  11. Any clotting disorder and/or use of any anticoagulant (e.g., warfarin, clopidogrel, etc.) within seven (7) days prior to administration of the treatment.
  12. Allergy or intolerance to any preparatory treatment agent or any other substance utilized within the study.
  13. Any local skin condition at the treatment site that in the investigator's opinion would adversely affect treatment, outcomes, or subject safety.
  14. Any confounding diagnosis or medical condition that in the investigator's opinion would adversely affect study participation or subject safety.
  15. Any chronic medication use (prescription, over-the-counter, supplements, etc.) that in the investigator's opinion would adversely affect study participation or subject safety.
  16. Any reason that, in the opinion of the investigator, the subject may not be a suitable candidate for study participation (i.e., history of noncompliance, drug dependency, any related foot injury due to a worker's compensation claim, etc.).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01753778

Locations
United States, California
SOAR Medical Group
Redwood City, California, United States, 94063
United States, Kansas
International Clinical Research
Overland Park, Kansas, United States, 66210
Sponsors and Collaborators
MyoScience, Inc
Investigators
Principal Investigator: Srinivas Nalamachu, MD International Clinical Research
Principal Investigator: Jonah Mullens, DPM SOAR Medical Group
  More Information

No publications provided

Responsible Party: MyoScience, Inc
ClinicalTrials.gov Identifier: NCT01753778     History of Changes
Other Study ID Numbers: MYO-0614
Study First Received: December 14, 2012
Last Updated: January 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by MyoScience, Inc:
Nerve Entrapment, Morton's neuroma, entrapment neuropathy

Additional relevant MeSH terms:
Charcot-Marie-Tooth Disease
Nerve Compression Syndromes
Hereditary Sensory and Motor Neuropathy
Nervous System Malformations
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Congenital Abnormalities
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on September 22, 2014