N/A
N=26
Study Evaluating the Treatment of Occipital Neuralgia
Occipital Neuralgia
Bottom Line
View on ClinicalTrials.gov: NCT01753765 ↗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
| Outcome | Result | p-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.
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.