CompletedNot Applicable

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

United States7 participantsStarted 2012-11

Plain-language 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 pain.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male or female, 18 years of age and older. Female subjects of childbearing potential must not be pregnant at time of treatment.
✓. Trial participants must have a confirmed diagnosis of pain in the forefoot that is due to entrapment of related nerves.
✓. Any medication must be maintained on a stable schedule for at least two weeks prior to treatment. No washout period is allowed.
✓. Must have an average score for pain of ≥ 4/10 Visual Analog Scale (VAS) over the last 7 days.
✓. Subject is willing and able to give written informed consent and able to comply with study instructions.
✓. Subject is willing and able to comply with study instructions and commit to all follow-up visits for the duration of the study.
✓. 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

✕. History of fibromyalgia, cerebrovascular accident (CVA), foot or lower limb trauma, stroke, or bone deformity.
✕. Patient who has severe pain for any reason other than forefoot pain due to nerve entrapment.
✕. Any additional diagnosis that in the opinion of the investigator directly contributes to forefoot pain.
✕. Any concomitant inflammatory disease or other condition that affects the joints (e.g. rheumatoid arthritis, metabolic bone disease, gout, active infection, etc.)
✕. Surgical invention previously conducted in the forefoot area.
✕. Any injection (neurolytic, sclerosing, anesthetic, etc.) to the foot within the last 2 months.
✕. Any use of systemic injections (in any area) for pain management within the last 4 months.
✕. Any use (i.e. oral, topical, inhaled and/or injected) of anesthetics or steroids within the last 30 days.

What they're measuring

Improvement of forefoot pain at day 7

Timeframe: 7 days

Trial details

NCT IDNCT01753778

SponsorPacira Pharmaceuticals, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-05

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