Study Evaluating the Treatment of Occipital Neuralgia

NCT01753765 | Completed Results DMC

• 1 other identifier: MYO-0613
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Occipital Neuralgia

Keywords

occipital neuralgia

Outcome Measures

Primary Outcomes (1)

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

  Improvement of pain due to occipital neuralgia as measured on the Visual Analog Scale (VAS) for pain at Days 7 and 30 as compared to baseline (Day 0). 0= no pain, 10= worst pain imaginable. Higher scores equal worse outcome.

  Baseline to Day 7, Baseline to Day 30

Secondary Outcomes (1)

• Duration of Treatment

  Day 30, Day 56

Study Arms (1)

Treatment

EXPERIMENTAL

Study treatment with Cryo-Touch III device at Day 0.

Device: Device: Cryo-Touch III Study treatment at Day 0.

Interventions

Device: Cryo-Touch III Study treatment at Day 0. DEVICE

Device: Cryo-Touch III Study treatment at Day 0.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (3)

Neurovations

Napa, California, 94557, United States

Location

Injury Care Medical Center

Boise, Idaho, 83713, United States

Location

International Clinical Research

Overland Park, Kansas, 66210, United States

Location

Results Point of Contact

• Title: Medical Information
• Organization: Pacira Bioscience, Inc.

MedInfo@Pacira.com

1-855-793-9729

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2012
• First Posted: December 20, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: July 1, 2014
• Last Updated: January 24, 2024
• Results First Posted: June 5, 2023

Record last verified: 2024-01

Locations

US (3)