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N/A N=26 Treatment

Study Evaluating the Treatment of Occipital Neuralgia

Occipital Neuralgia

Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: A Reduction in Either Pain Frequency or Severity Associated With Occipital Neuralgia. — 2.5; 2.7 point improvement

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Device: Cryo-Touch III Study treatment at Day 0. (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Pacira Pharmaceuticals, Inc
Primary completion
Dec 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
A Reduction in Either Pain Frequency or Severity Associated With Occipital Neuralgia.
2.5; 2.7
SECONDARY
Duration of Treatment
13; 9

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.

Eligibility Criteria

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.
  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01753765). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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