CompletedNot Applicable

Study Evaluating the Treatment of Occipital Neuralgia

United States26 participantsStarted 2012-10

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 or reduction in pain due to occipital neuralgia.

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.
✓. A confirmed diagnosis of occipital neuralgia (unilateral or bilateral) .
✓. 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.

Exclusion criteria

✕. Current diagnosis of fibromyalgia, chronic back pain, or chronic migraines.
✕. Any injections intended for pain relief or neuromodulation to the upper trunk or head within the last 3 months.
✕. History of a cerebrovascular accident (CVA), head trauma, stroke, or bone deformity.
✕. Patient who has severe pain for any reason other than occipital neuralgia.
✕. Any use of (i.e. oral, topical, inhaled and/or injected) anesthetics or steroids within the last 30 days.
✕. Any previous surgery in the intended treatment area.
✕. Currently enrolled in any other investigational drug or device study or participation within the last 30 days.
✕. Any clotting disorder and/or use of any anticoagulant (e.g., warfarin, clopidogrel, etc.) within seven (7) days prior to administration of the treatment.

What they're measuring

A Reduction in Either Pain Frequency or Severity Associated With Occipital Neuralgia.

Timeframe: Baseline to Day 7, Baseline to Day 30

Trial details

NCT IDNCT01753765

SponsorPacira Pharmaceuticals, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-12

Results submitted2023-05-03

View on ClinicalTrials.gov More Occipital Neuralgia trials