Nerve PainNCT06583122
Ultrasound Guided Radiofrequency Ablation of the Occipital Nerve
A study testing Ultrasound Guided Approach in people with Nerve Pain, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
Study an ultrasound guided approach to radiofrequency ablation of the occipital nerve that makes it possible to see the needle during treatment procedure. It is hoped this will reduce the amount of pain after the standard of care procedure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nerve Pain
- What is being tested?
- Ultrasound Guided Approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between the ages of 18-80 with a diagnosis of occipital neuralgia or migraine overlying the occipital region.
- A diagnosis of occipital neuralgia will be based on the International Classification of Headache Disorders (ICHD), whose criteria include: paroxysmal stabbing pain in the distribution of the GON, tenderness over the affected nerve, and relief of pain for at least 3 hours after bupivacaine local anesthetic block of the affected nerve.
- Patients may also be included if they have a diagnosis of migraine based on the ICHD criteria with predominance of pain over the occipital region that responded to occipital nerve block.
- Patients must have failed oral medications including NSAIDs, opioids, and anticonvulsants for the management of their pain.
- Failed treatment will be <50% pain reduction with oral medication.
- Patients must report headache frequency of at least 10 days per month.
Who cannot join
- Patients will be excluded from the trial if they have an unstable medical or psychological condition,
- are pregnant,
- have an implanted cardiac pacemaker or defibrillator that could not be disabled,
- have had a craniotomy or scar tissue overlying the site from a previous surgery,
- have a history of cervical spine fusion,
- have evidence of elevated ICP or intracranial tumor,
- or have previous RFA treatment of the greater or lesser occipital nerve.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Manuel Clark, 9139455763, mclark16@kumc.edu
About this study
Study an ultrasound guided approach to radiofrequency ablation of the occipital nerve that makes it possible to see the needle during treatment procedure. It is hoped this will reduce the amount of pain after the standard of care procedure.
- Conditions
- Nerve Pain
- Being tested
- Ultrasound Guided Approach
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Guided ApproachProcedure or surgery
All enrolled patients will receive the new ultrasound-guided approach to occipital nerve radiofrequency ablation
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Guided Approach | Experimental | Ultrasound-guided approach to occipital nerve radiofrequency ablation Receives: Procedure: Ultrasound Guided Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction pain scores reported using an 11-point numeric rating scale (NRS)
Pain scores will be assessed 0-10 at the beginning of the study and at the end. We will compare mean pain scores pre-intervention and post-intervention, and we expect mean pain scores will decrease by 4 points on the NRS
Measured: 18 Months
Secondary outcomes (3)
Frequency of headache days
We will compare frequency of headache days pre-intervention and post-intervention
Measured: 18 months
Frequency of moderate-severe headaches
We will compare frequency of moderate-severe headaches days pre-intervention and post-intervention
Measured: 18 months
Use of acute pain medications
We will compare frequency of Use of acute pain medications pre-intervention and post-intervention
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start1 Jul 2022
- Primary completion30 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve PainStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Sowder, MD, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583122
- Sponsor's protocol ID
- STUDY00148697
- Status last verified
- Dec 2024
- First submitted
- 30 Aug 2024
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Radiofrequency Ablation of the Occipital Nerve
- ClinicalTrials.gov ID
- NCT06583122
- Acronym / sponsor ID
- STUDY00148697
- Conditions
- Nerve Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study an ultrasound guided approach to radiofrequency ablation of the occipital nerve that makes it possible to see the needle during treatment procedure. It is hoped this will reduce the amount of pain after the standard of care procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Guided Approach | Experimental | Procedure: Ultrasound Guided ApproachUltrasound-guided approach to occipital nerve radiofrequency ablation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients between the ages of 18-80 with a diagnosis of occipital neuralgia or migraine overlying the occipital region.
- A diagnosis of occipital neuralgia will be based on the International Classification of Headache Disorders (ICHD), whose criteria include: paroxysmal stabbing pain in the distribution of the GON, tenderness over the affected nerve, and relief of pain for at least 3 hours after bupivacaine local anesthetic block of the affected nerve.
- Patients may also be included if they have a diagnosis of migraine based on the ICHD criteria with predominance of pain over the occipital region that responded to occipital nerve block.
- Patients must have failed oral medications including NSAIDs, opioids, and anticonvulsants for the management of their pain.
- Failed treatment will be <50% pain reduction with oral medication.
Key exclusion criteria (7 listed)
- Patients will be excluded from the trial if they have an unstable medical or psychological condition,
- are pregnant,
- have an implanted cardiac pacemaker or defibrillator that could not be disabled,
- have had a craniotomy or scar tissue overlying the site from a previous surgery,
- have a history of cervical spine fusion,
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 |
|---|---|---|
| Ultrasound Guided ApproachAll enrolled patients will receive the new ultrasound-guided approach to occipital nerve radiofrequency ablation | Procedure or surgery | Ultrasound Guided Approach |
Primary outcome
Reduction pain scores reported using an 11-point numeric rating scale (NRS)
Time frame: 18 Months
Pain scores will be assessed 0-10 at the beginning of the study and at the end. We will compare mean pain scores pre-intervention and post-intervention, and we expect mean pain scores will decrease by 4 points on the NRS
3 secondary outcomes
Frequency of headache days
Time frame: 18 months
Frequency of moderate-severe headaches
Time frame: 18 months
Use of acute pain medications
Time frame: 18 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Guided Approach in people with Nerve Pain, run by University of Kansas Medical Center at 1 site 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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Timothy Sowder, MD (913-588-6670, tsowder@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction pain scores reported using an 11-point numeric rating scale (NRS) (time frame: 18 Months). 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 9 Apr 2025.