Occipital NeuralgiaNCT01753765
Study Evaluating the Treatment of Occipital Neuralgia
A study testing Device: Cryo-Touch III Study treatment at Day 0. in people with Occipital Neuralgia, run by Pacira Pharmaceuticals, Inc at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Occipital Neuralgia
- What is being tested?
- Device: Cryo-Touch III Study treatment at Day 0.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2012to Jul 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Injury Care Medical Center
Boise, Idaho, 83713
Neurovations
Napa, California, 94557
International Clinical Research
Overland Park, Kansas, 66210
About this study
Official title: A Prospective Non-Randomized Unblinded Study Evaluating the Treatment of Occipital Neuralgia With the Cryo-Touch III Device
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.
Read the detailed description
Over 100 million patients in the United States suffer from chronic pain. Chronic pain conditions are often debilitating, taking a toll on a patient's physical and mental welfare. Though a variety of pain management techniques currently exist, the most common nonsurgical options provide slow-acting and/or short-term relief. Medication, often in the form of non-steroidal anti-inflammatory drugs (NSAIDs) and opioids, comes with an array of side effects such as nausea and vomiting. Medication also presents the possibility of more serious effects such as increased risk of heart attack and stroke, and tolerance or dependency issues. Surgical strategies tend to be reserved for more severe cases and are limited by the risks and complications typically associated with surgery including bleeding, bruising, scarring, and infection. A nonsurgical, minimally invasive, long-lasting approach to chronic pain management is desirable.
Myoscience, Inc. (Redwood City, CA) has developed a pain management device - the Cryo-Touch III - for a novel, minimally invasive procedure using focused cold therapy to target sensory nerve tissue and offer long-lasting pain relief through cryoanalgesia. The device operates on the well-established cryobiology principle that localized exposure to controlled, moderately low temperature conditions can alter tissue function. The therapy treats nerves via a probe in the form of an assembly of small diameter needles, creating a highly localized, low temperature treatment zone around the probe. This focused cold therapy creates a conduction block that prevents nerve signaling. Prior studies of the Cryo-Touch, Cryo-Touch II, Cryo-Touch III (a.k.a. PCP 1.0) devices have provided preliminary evidence of effectiveness on motor nerves and have been shown to be safe with no serious device-related adverse events.
Though studies have proven efficacious in targeting motor nerves, the device's effect on sensory nerves has yet to be investigated in the clinical setting. The goal of the study described herein is to evaluate the degree and duration of effect of the Cryo-Touch III in reducing chronic pain by targeting sensory nerves.
- Conditions
- Occipital Neuralgia
- Being tested
- Device: Cryo-Touch III Study treatment at Day 0.
- Keywords
- occipital neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: Cryo-Touch III Study treatment at Day 0.Device
Device: Cryo-Touch III Study treatment at Day 0.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Study treatment with Cryo-Touch III device at Day 0. Receives: Device: Device: Cryo-Touch III Study treatment at Day 0. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Day 7, Baseline to Day 30
Secondary outcomes (1)
Duration of Treatment
Treatment effect was based on Subject response when asked if the Subject had an effect from the treatment.
Measured: Day 30, Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2013
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Occipital NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753765
- Sponsor's protocol ID
- MYO-0613
- Status last verified
- Jan 2024
- First submitted
- 14 Dec 2012
- Last updated
- 24 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Non-Randomized Unblinded Study Evaluating the Treatment of Occipital Neuralgia With the Cryo-Touch III Device
- ClinicalTrials.gov ID
- NCT01753765
- Acronym / sponsor ID
- MYO-0613
- Conditions
- Occipital Neuralgia
- Keywords
- occipital neuralgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 20 Dec 2012 (estimated)
- Results
- Posted 5 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Over 100 million patients in the United States suffer from chronic pain. Chronic pain conditions are often debilitating, taking a toll on a patient's physical and mental welfare. Though a variety of pain management techniques currently exist, the most common nonsurgical options provide slow-acting and/or short-term relief. Medication, often in the form of non-steroidal anti-inflammatory drugs (NSAIDs) and opioids, comes with an array of side effects such as nausea and vomiting. Medication also presents the possibility of more serious effects such as increased risk of heart attack and stroke, and tolerance or dependency issues. Surgical strategies tend to be reserved for more severe cases and are limited by the risks and complications typically associated with surgery including bleeding, bruising, scarring, and infection. A nonsurgical, minimally invasive, long-lasting approach to chronic pain management is desirable.
Myoscience, Inc. (Redwood City, CA) has developed a pain management device - the Cryo-Touch III - for a novel, minimally invasive procedure using focused cold therapy to target sensory nerve tissue and offer long-lasting pain relief through cryoanalgesia. The device operates on the well-established cryobiology principle that localized exposure to controlled, moderately low temperature conditions can alter tissue function. The therapy treats nerves via a probe in the form of an assembly of small diameter needles, creating a highly localized, low temperature treatment zone around the probe. This focused cold therapy creates a conduction block that prevents nerve signaling. Prior studies of the Cryo-Touch, Cryo-Touch II, Cryo-Touch III (a.k.a. PCP 1.0) devices have provided preliminary evidence of effectiveness on motor nerves and have been shown to be safe with no serious device-related adverse events.
Though studies have proven efficacious in targeting motor nerves, the device's effect on sensory nerves has yet to be investigated in the clinical setting. The goal of the study described herein is to evaluate the degree and duration of effect of the Cryo-Touch III in reducing chronic pain by targeting sensory nerves.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Device: Cryo-Touch III Study treatment at Day 0.Study treatment with Cryo-Touch III device at Day 0. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device: Cryo-Touch III Study treatment at Day 0.Device: Cryo-Touch III Study treatment at Day 0. | Device | Treatment |
Primary outcome
A Reduction in Either Pain Frequency or Severity Associated With Occipital Neuralgia.
Time frame: Baseline to Day 7, Baseline to Day 30
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.
1 secondary outcome
Duration of Treatment
Time frame: Day 30, Day 56
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Occipital Neuralgia
RecruitingObservational study
Prospective Case Series Evaluating 6-Month and 12-Month Outcomes After Cryoneurolysis for Chronic Pain
Chronic Pain, PERIPHERAL NEUROPATHY
Active, not recruiting
The MONARCH Case Series Study: SPRINT® Peripheral Nerve Stimulation for the Treatment of Head Pain
Cervicogenic Headache, Occipital Neuralgia
Recruiting
Efficacy of Adding Greater Occipital Nerve Block to Trigger Point Injection in Patients With Neck Pain
Neck Pain, Myofacial Pain Syndrome
Not yet recruitingPhase 3
0.5% Bupivacaine Lower Cervical Intramuscular Injection vs IV Medications for Headache Treatment
Headache, Migraine
Recruiting
Ultrasound Guided Radiofrequency Ablation of the Occipital Nerve
Nerve Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device: Cryo-Touch III Study treatment at Day 0. in people with Occipital Neuralgia, run by Pacira Pharmaceuticals, Inc at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A Reduction in Either Pain Frequency or Severity Associated With Occipital Neuralgia. (time frame: Baseline to Day 7, Baseline to Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.