Occipital NeuralgiaNCT04124458
Occipital Nerve RF Between Occipital Nerve Block And Occipital Nerve Radiofrequency Ablation
A study testing Radiofrequency ablation in people with Occipital Neuralgia and Headache, run by Allevio Pain Management Clinic.
Trial summary
This is a randomized, double blind, single-center, clinical trial. The study will be conducted over a period of 6 months. The study will be conducted at the Allevio Pain Clinic, Toronto, Canada. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Occipital Neuralgia, Headache
- What is being tested?
- Radiofrequency ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-90
- Confirmed diagnosis of occipital headaches, patients with concurrent other types of headaches will not be excluded (except undiagnosed headaches)
- Duration of occipital headaches > 3 months
Who cannot join
- Non-English speakers;
- Refusal to sign informed consent;
- Allergy to medications which will be used in the study;
- Concurrent undiagnosed headaches
- Current brain tumors
- Current known tumors with known metastasis in other organs
Show all 9Show fewer
- Occipital blocks within the last 3 months
- Currently receiving treatment with Botox for migraine.
- Patient has RF of occipital nerve/s within the last year
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Comparison of Pain Control AND Quality of Life Improvement Between Occipital Nerve Block And Occipital Nerve Radiofrequency Ablation: A Double-Blind Single Center Prospective Study
This is a randomized, double blind, single-center, clinical trial. The study will be conducted over a period of 6 months. The study will be conducted at the Allevio Pain Clinic, Toronto, Canada.
Read the detailed description
During the first visit the investigator will assess potential subject's eligibility. Screening and recruitment, and randomization, and administer questionnaires will be performed by research coordinator. Study informed consent form (ICF) can be signed on the RF procedure day. If additional visits will be required to finalize the procedures related to the first visit they will be scheduled accordingly. After randomization the qualified participants will be scheduled for their bilateral Occipital RF or bilateral Occipital Block.
Participants will be asked to complete the follow-up questionnaires at baseline, 3 and 6 months. On their last study visit, participants will have an exit interview, in addition to completing study measures.
- Conditions
- Occipital Neuralgia, Headache
- Being tested
- Radiofrequency ablation
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablationDevice
In radiofrequency ablation arm, sensory brunch of occipital nerve will be burn with max allowable temperature: 42 degrees Celsius, real temperature: 41 degrees Celsius, power=65 volts, two cycles of 180 second.
| Study group | Role | What they receive |
|---|---|---|
| Pulsed Radiofrequency Ablation | Active comparator | In radiofrequency ablation arm, sensory brunch of occipital nerve will be burn with max allowable temperature: 42 degrees Celsius, real temperature: 41 degrees Celsius, power=65 volts, two cycles of 180 second. Receives: Device: Radiofrequency ablation |
| Bilateral Occipital Nerve Block | Active comparator | In this arm all steps are the same as other arm, except the generator will not be on and patient will have pain relief by injecting numbing medications beside the sensory nerves. Receives: Device: Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life assessment: Short Form Brief Pain Inventory (BPI-SF)
measured by Short Form Brief Pain Inventory (BPI-SF), between minimum of zero and maximum of ten
Measured: Change from baseline BPI-SF at 6 months
Secondary outcomes (6)
At Least of 30% decrease in the pain score
measured by Visual Analog Scale (VAS), between minimum of zero and maximum of ten
Measured: Baseline, every 3 months up to 6 months
At Least of 30% decrease in the pain score
measured by The Migraine Disability Assessment Test (MIDAS), between minimum of zero and maximum of twenty one
Measured: Baseline, every 3 months up to 6 months
Quality of life assessment
measured by Beck's Depression Inventory (BDI)
Measured: Baseline, every 3 months up to 6 months
Quality of life assessment: General Anxiety Disorder Questionnaire (GAD)
measured by General Anxiety Disorder Questionnaire (GAD)
Measured: Baseline, every 3 months up to 6 months
Quality of life assessment: Patients self-reported perceived duration of effect (PSPDE)
measured by Patients self-reported perceived duration of effect (PSPDE)
Measured: Baseline, every 3 months up to 6 months
Quality of life assessment: Global Improvement and Satisfaction score measured by PGIC)
measured by Global Improvement and Satisfaction score measured by PGIC)
Measured: Baseline, every 3 months up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start2 Jan 2023 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, double blind, single-center, clinical trial. Participants will be randomly allocated to P-RF or occipital block intervention groups in a 1:1 ratio using a computer-generated algorithm. The study will be conducted over a period of 6 months, during which patients will make 4 visits (screening, baseline visit (Day 0) and 3, 6 months follow up visits, with ±1-week window). The study will be conducted at the Allevio Pain Clinic, Toronto, Canada. Research Ethics approvals will be sought.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allevio Pain Management Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124458
- Sponsor's protocol ID
- 16397-11:07:0126-08-2019
- Status last verified
- Jan 2022
- First submitted
- 9 Oct 2019
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
13. Cohen J. Statistical power analysis for the behavioral sciences. 2nd ed. Hillsdale, NJ: L. Erlbaum, 1988.
Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.
PubMed 23771276Steiner TJ, Paemeleire K, Jensen R, Valade D, Savi L, Lainez MJ, Diener HC, Martelletti P, Couturier EG; European Headache Federation; Lifting The Burden: The Global Campaign to Reduce the Burden of Headache Worldwide; World Health Organization. European principles of management of common headache disorders in primary care. J Headache Pain. 2007 Oct;8 Suppl 1:S3-47. doi: 10.1007/s10194-007-0366-y. No abstract available.
PubMed 18034215Stovner Lj, Hagen K, Jensen R, Katsarava Z, Lipton R, Scher A, Steiner T, Zwart JA. The global burden of headache: a documentation of headache prevalence and disability worldwide. Cephalalgia. 2007 Mar;27(3):193-210. doi: 10.1111/j.1468-2982.2007.01288.x.
PubMed 17381554Ducic I, Felder JM 3rd, Fantus SA. A systematic review of peripheral nerve interventional treatments for chronic headaches. Ann Plast Surg. 2014 Apr;72(4):439-45. doi: 10.1097/SAP.0000000000000063.
PubMed 24374395Inan N, Inan LE, Coskun O, Tunc T, Ilhan M. Effectiveness of Greater Occipital Nerve Blocks in Migraine Prophylaxis. Noro Psikiyatr Ars. 2016 Mar;53(1):45-48. doi: 10.5152/npa.2015.10003. Epub 2016 Mar 1.
PubMed 28360765Okmen K, Dagistan Y, Dagistan E, Kaplan N, Cancan E. Efficacy of the greater occipital nerve block in recurrent migraine type headaches. Neurol Neurochir Pol. 2016;50(3):151-4. doi: 10.1016/j.pjnns.2016.01.015. Epub 2016 Feb 6.
PubMed 27154440Hascalovici JR, Robbins MS. Peripheral Nerve Blocks for the Treatment of Headache in Older Adults: A Retrospective Study. Headache. 2017 Jan;57(1):80-86. doi: 10.1111/head.12992. Epub 2016 Nov 30.
PubMed 27901275Kim DD, Sibai N. Prolongation of greater occipital neural blockade with 10% lidocaine neurolysis: a case series of a new technique. J Pain Res. 2016 Sep 29;9:721-725. doi: 10.2147/JPR.S112947. eCollection 2016.
PubMed 27729811Cohen SP, Peterlin BL, Fulton L, Neely ET, Kurihara C, Gupta A, Mali J, Fu DC, Jacobs MB, Plunkett AR, Verdun AJ, Stojanovic MP, Hanling S, Constantinescu O, White RL, McLean BC, Pasquina PF, Zhao Z. Randomized, double-blind, comparative-effectiveness study comparing pulsed radiofrequency to steroid injections for occipital neuralgia or migraine with occipital nerve tenderness. Pain. 2015 Dec;156(12):2585-2594. doi: 10.1097/j.pain.0000000000000373.
PubMed 2644770511. Cervicogenic headache in Headache and Migraine Biology and Management 2015, Pages 203-212. Cooper W, Masih A.
Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, Haythornthwaite JA, Jensen MP, Kerns RD, Ader DN, Brandenburg N, Burke LB, Cella D, Chandler J, Cowan P, Dimitrova R, Dionne R, Hertz S, Jadad AR, Katz NP, Kehlet H, Kramer LD, Manning DC, McCormick C, McDermott MP, McQuay HJ, Patel S, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Revicki DA, Rothman M, Schmader KE, Stacey BR, Stauffer JW, von Stein T, White RE, Witter J, Zavisic S. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008 Feb;9(2):105-21. doi: 10.1016/j.jpain.2007.09.005. Epub 2007 Dec 11.
PubMed 18055266
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Pain Control AND Quality of Life Improvement Between Occipital Nerve Block And Occipital Nerve Radiofrequency Ablation: A Double-Blind Single Center Prospective Study
- ClinicalTrials.gov ID
- NCT04124458
- Acronym / sponsor ID
- 16397-11:07:0126-08-2019
- Conditions
- Occipital Neuralgia, Headache
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Allevio Pain Management ClinicUniversity, hospital or other
- Study start
- 2 Jan 2023 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 Oct 2019 (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.
This is a randomized, double blind, single-center, clinical trial. The study will be conducted over a period of 6 months. The study will be conducted at the Allevio Pain Clinic, Toronto, Canada.
Detailed description
During the first visit the investigator will assess potential subject's eligibility. Screening and recruitment, and randomization, and administer questionnaires will be performed by research coordinator. Study informed consent form (ICF) can be signed on the RF procedure day. If additional visits will be required to finalize the procedures related to the first visit they will be scheduled accordingly. After randomization the qualified participants will be scheduled for their bilateral Occipital RF or bilateral Occipital Block.
Participants will be asked to complete the follow-up questionnaires at baseline, 3 and 6 months. On their last study visit, participants will have an exit interview, in addition to completing study measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- This is a randomized, double blind, single-center, clinical trial. Participants will be randomly allocated to P-RF or occipital block intervention groups in a 1:1 ratio using a computer-generated algorithm. The study will be conducted over a period of 6 months, during which patients will make 4 visits (screening, baseline visit (Day 0) and 3, 6 months follow up visits, with ±1-week window). The study will be conducted at the Allevio Pain Clinic, Toronto, Canada. Research Ethics approvals will be sought.
| Arm | Type | Receives |
|---|---|---|
| Pulsed Radiofrequency Ablation | Active comparator | Device: Radiofrequency ablationIn radiofrequency ablation arm, sensory brunch of occipital nerve will be burn with max allowable temperature: 42 degrees Celsius, real temperature: 41 degrees Celsius, power=65 volts, two cycles of 180 second. |
| Bilateral Occipital Nerve Block | Active comparator | Device: Radiofrequency ablationIn this arm all steps are the same as other arm, except the generator will not be on and patient will have pain relief by injecting numbing medications beside the sensory nerves. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-90
- Confirmed diagnosis of occipital headaches, patients with concurrent other types of headaches will not be excluded (except undiagnosed headaches)
- Duration of occipital headaches > 3 months
Key exclusion criteria (9 listed)
- Non-English speakers;
- Refusal to sign informed consent;
- Allergy to medications which will be used in the study;
- Concurrent undiagnosed headaches
- Current brain tumors
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 |
|---|---|---|
| Radiofrequency ablationIn radiofrequency ablation arm, sensory brunch of occipital nerve will be burn with max allowable temperature: 42 degrees Celsius, real temperature: 41 degrees Celsius, power=65 volts, two cycles of 180 second. | Device | Bilateral Occipital Nerve Block, Pulsed Radiofrequency Ablation |
Primary outcome
Quality of life assessment: Short Form Brief Pain Inventory (BPI-SF)
Time frame: Change from baseline BPI-SF at 6 months
measured by Short Form Brief Pain Inventory (BPI-SF), between minimum of zero and maximum of ten
6 secondary outcomes
At Least of 30% decrease in the pain score
Time frame: Baseline, every 3 months up to 6 months
At Least of 30% decrease in the pain score
Time frame: Baseline, every 3 months up to 6 months
Quality of life assessment
Time frame: Baseline, every 3 months up to 6 months
Quality of life assessment: General Anxiety Disorder Questionnaire (GAD)
Time frame: Baseline, every 3 months up to 6 months
Quality of life assessment: Patients self-reported perceived duration of effect (PSPDE)
Time frame: Baseline, every 3 months up to 6 months
Quality of life assessment: Global Improvement and Satisfaction score measured by PGIC)
Time frame: Baseline, every 3 months up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Background13. Cohen J. Statistical power analysis for the behavioral sciences. 2nd ed. Hillsdale, NJ: L. Erlbaum, 1988.
- Results publication: PubMed 23771276Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.
- Results publication: PubMed 18034215Steiner TJ, Paemeleire K, Jensen R, Valade D, Savi L, Lainez MJ, Diener HC, Martelletti P, Couturier EG; European Headache Federation; Lifting The Burden: The Global Campaign to Reduce the Burden of Headache Worldwide; World Health Organization. European principles of management of common headache disorders in primary care. J Headache Pain. 2007 Oct;8 Suppl 1:S3-47. doi: 10.1007/s10194-007-0366-y. No abstract available.
- Results publication: PubMed 17381554Stovner Lj, Hagen K, Jensen R, Katsarava Z, Lipton R, Scher A, Steiner T, Zwart JA. The global burden of headache: a documentation of headache prevalence and disability worldwide. Cephalalgia. 2007 Mar;27(3):193-210. doi: 10.1111/j.1468-2982.2007.01288.x.
- Results publication: PubMed 24374395Ducic I, Felder JM 3rd, Fantus SA. A systematic review of peripheral nerve interventional treatments for chronic headaches. Ann Plast Surg. 2014 Apr;72(4):439-45. doi: 10.1097/SAP.0000000000000063.
- Results publication: PubMed 28360765Inan N, Inan LE, Coskun O, Tunc T, Ilhan M. Effectiveness of Greater Occipital Nerve Blocks in Migraine Prophylaxis. Noro Psikiyatr Ars. 2016 Mar;53(1):45-48. doi: 10.5152/npa.2015.10003. Epub 2016 Mar 1.
- Results publication: PubMed 27154440Okmen K, Dagistan Y, Dagistan E, Kaplan N, Cancan E. Efficacy of the greater occipital nerve block in recurrent migraine type headaches. Neurol Neurochir Pol. 2016;50(3):151-4. doi: 10.1016/j.pjnns.2016.01.015. Epub 2016 Feb 6.
- Results publication: PubMed 27901275Hascalovici JR, Robbins MS. Peripheral Nerve Blocks for the Treatment of Headache in Older Adults: A Retrospective Study. Headache. 2017 Jan;57(1):80-86. doi: 10.1111/head.12992. Epub 2016 Nov 30.
- Results publication: PubMed 27729811Kim DD, Sibai N. Prolongation of greater occipital neural blockade with 10% lidocaine neurolysis: a case series of a new technique. J Pain Res. 2016 Sep 29;9:721-725. doi: 10.2147/JPR.S112947. eCollection 2016.
- Results publication: PubMed 26447705Cohen SP, Peterlin BL, Fulton L, Neely ET, Kurihara C, Gupta A, Mali J, Fu DC, Jacobs MB, Plunkett AR, Verdun AJ, Stojanovic MP, Hanling S, Constantinescu O, White RL, McLean BC, Pasquina PF, Zhao Z. Randomized, double-blind, comparative-effectiveness study comparing pulsed radiofrequency to steroid injections for occipital neuralgia or migraine with occipital nerve tenderness. Pain. 2015 Dec;156(12):2585-2594. doi: 10.1097/j.pain.0000000000000373.
- Results publication11. Cervicogenic headache in Headache and Migraine Biology and Management 2015, Pages 203-212. Cooper W, Masih A.
- Results publication: PubMed 18055266Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, Haythornthwaite JA, Jensen MP, Kerns RD, Ader DN, Brandenburg N, Burke LB, Cella D, Chandler J, Cowan P, Dimitrova R, Dionne R, Hertz S, Jadad AR, Katz NP, Kehlet H, Kramer LD, Manning DC, McCormick C, McDermott MP, McQuay HJ, Patel S, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Revicki DA, Rothman M, Schmader KE, Stacey BR, Stauffer JW, von Stein T, White RE, Witter J, Zavisic S. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008 Feb;9(2):105-21. doi: 10.1016/j.jpain.2007.09.005. Epub 2007 Dec 11.
- 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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation in people with Occipital Neuralgia and Headache, run by Allevio Pain Management Clinic.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SHADI BABAZADEH, MD (+16474788462, Shadi.Babazadeh@AllevioClinic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life assessment: Short Form Brief Pain Inventory (BPI-SF) (time frame: Change from baseline BPI-SF at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04124458, which also lists 12 linked publications.
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 15 Feb 2022.