Study Evaluating the Treatment of Occipital Neuralgia

Completed · Not applicable

Conditions studied: Occipital Neuralgia

In brief

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.

Key facts

Study ID

NCT01753765

Run by

Pacira Pharmaceuticals, Inc

People needed

26

Starts

2012-10-01

Expected to finish

2014-07-01

Last updated by the study team

2024-01-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Allergy or intolerance to any preparatory treatment agent or any other substance utilized within the study.
• Any local skin condition at the treatment site that would adversely affect treatment or subject safety.
• Any confounding diagnosis or medical condition that in the investigator's opinion would adversely affect study participation or subject safety.
• Any chronic medication use (prescription, over-the-counter, supplements, etc.) that in the investigator's opinion would adversely affect study participation or subject safety.

Where it is running

• Neurovations — Napa, California, United States
• Injury Care Medical Center — Boise, Idaho, United States
• International Clinical Research — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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