Faceto-genic Neck PainNCT04124445
Pulsed vs Continuous Radiofrequency Neurotomy for Cervical Facet Joint Mediated Pain
A study testing Pulsed Radiofrequency Ablation in people with Faceto-genic Neck Pain and Shoulder Pain Chronic, run by Allevio Pain Management Clinic at 2 sites in Canada.
Trial summary
Different studies have revealed different success rates and patient satisfaction after cervical facet C-RF. In a study on 32 patients, with 15 months follow up, 25% had complete pain relief (8). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Faceto-genic Neck Pain, Shoulder Pain Chronic, Faceto-genic Headache
- What is being tested?
- Pulsed Radiofrequency Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 2 sitesCanada
- Study dates
- 10 Feb 2020to 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;
- Pain duration > 3 months
- Cervical, Shoulder pain or cevicogenic Headache per Pain Diagram;
- Two single blinded facet medial branch blocks (MBB) performed 30 days prior to the facet RF;
- Subjects show 50% and more pain relief after each MBB (using VAS for this assessment);
- Unsuccessful or poorly tolerated previous treatments including: pain control medications, chiropractic, osteopathy, massage therapy, physiotherapy, acupuncture, aqua therapy, Botox injection, and trigger point injection;
Who cannot join
- Non-English speakers;
- Refusal to sign informed consent;
- Less than 50% pain relief after MBB (using VAS);
- Variation in the dose of concomitant pain control medication less than 4 weeks before the procedure;
- Allergy to medication or radiology contrast;
- Patients with coagulation issues, those currently using anticoagulants and didn't stop them based on Allevio clinic's policy for anticoagulants;
- Pregnant patients;
- Any pain interventions including previous RF, MBB, infusions 90 days prior to the first MBB for the same area (Except failed Botox injection, and trigger point injection);
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Allevio Pain Management Clinic
Toronto, Ontario, M3B 3S6
Ramin Safakish, MD. FRCPC, 6474788462, Ramin.Safakish@AllevioClinic.com
Shadi Babazadeh, MD, 6474788462 ext. Safakish, Shadi.Babazadeh@AllevioClinic.com
- Recruiting
Allevio Pain Management
Toronto, Ontario, M3B 3S6
Ramin Safakish, MD, FRCPC, 6474788462, Ramin.Safakish@allevioclinic.com
Imrat Sohanpal, MD, FRCPC, 6474788462, Imrat.Sohanpal@allevioclinic.com
About this study
Official title: Pulsed vs Continuous Radiofrequency Neurotomy for Cervical Facet Joint Mediated Pain: a Single-blind Randomized Controlled Clinical Trial
Different studies have revealed different success rates and patient satisfaction after cervical facet C-RF. In a study on 32 patients, with 15 months follow up, 25% had complete pain relief (8). Another study had shown mean pain relief of 12.5 months and 11.5 months following a repeat procedure, with an effectiveness of 95% in 47 patients (8). In one study a success rate of 88% after first RF, and 86% following a repeat RF in 49 patients with facet mediated cervicogenic headache. They regarded the absence of anesthesia in the distribution of the 3rd occipital nerve, a technical failure (9). In a study from New Zealand, demonstrated cervical facet RF as the sole treatment modality, produced 61% -74% complete pain relief with a median duration of 15-17 months in patients who had responded to facet joints diagnostic block (10).
One more study in 2012 has demonstrated high voltage P-RF had a higher short-term effect compare to usual voltage, but results are still lower than C-RF (11). A double blind randomized prospective study has illustrated P-RF did not show any success rate in 6 months pain control, whereas C-RF had 95% pain control for trigeminal neuralgia (12).
Cohen in a recent study has compared P-RF with steroid injection for occipital neuralgia or migraine with occipital nerve tenderness (13). Six weeks pain relief was 61% in P-RF group, and 36% in steroid injection group, with a positive outcome of 34%, and 26% respectively (13). One study on 2010 had reached to 52.6%, 6 months pain improvement on occipital neuralgia (14).
Read the detailed description
Patients fulfilling eligibility criteria will be randomly allocated to PRF or CRF in a 1:1 ratio. The statistician will use RedCap software to generate random numbers. Patients will be registered to Redcap software and will be concealed from both patients and health care staff. The study coordinator will enter patients' consent and study eligibility information to the Redcap. Once eligible, the Redcap will assign the patient to one of the study group. Patients will be blinded in the proposed study. The assessor is the person who will assess treatment success at the end of the study based on data from completed questionnaires. Questionnaires will be completed every three months by patients through RedCap System. A therapist is the person who will perform the procedure (pain specialist physician). The therapist will not be blinded, because of the nature of intervention.
Patient recruitment is estimated to be completed within 15-24 months. If the required sample size (calculated below) is recruited prior to this time, patient recruitment will be curtailed.
During the first visit the investigator will perform eligibility for neck RF and patient will be received information about the study.
Patients will be book for two MBB 4-6 weeks apart. If the patient was eligible after the second MBB, Patient will be asked to sign Informed consent before screening. Screening and recruitment, and randomization, and administer questionnaires will be performed by research co-ordinator. 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 RF.
For the female subjects between the age of 18-50 a pregnancy test will be asked to obtain on screening visit in order to reduce the risk of pregnancy and potential harm to fetus, unless you had previous tubal ligation, or hysterectomy. Post menopause patients are excluded.
Participants will be asked to complete the follow-up questionnaires at 1, 3, 6, 9, and 12 months.
LANSS questionnaire will be asked to be completed 6 weeks after RF. If the score was 12 or higher, patient will be asked to complete them every 4 weeks after till the score reduce to less than 12. LANSS will be sent to the subjects through RedCap software.
On their last study visit, participants will have an exit interview, in addition to completing study measures.
- Being tested
- Pulsed Radiofrequency Ablation
- Keywords
- Faceto-genic Cervical pain, Chronic pain, Pulsed Radiofrequency ablation, Continues Radiofrequency ablation, Medial Brunch Block
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Radiofrequency AblationProcedure or surgery
Also called Continuous Radiofrequency Ablation
Radiofrequency ablation, also called rhizotomy, is a nonsurgical, minimally invasive procedure that uses heat to reduce or stop the transmission of pain. Radiofrequency waves ablate, or "burn," the nerve that is causing the pain, essentially eliminating the transmission of pain signals to the brain.
| Study group | Role | What they receive |
|---|---|---|
| Pulsed Radiofrequency Ablation | Active comparator | Radiofrequency ablation of sensory nerves at minimum 3 levels of cervical spine with Maximum allowable temperature 50° rotation: 90.; Pulse rate: 3 Hz; pulse duration: 50 ms; 3 minutes Receives: Procedure: Pulsed Radiofrequency Ablation |
| Continuous Radiofrequency Ablation | Active comparator | Radiofrequency ablation of sensory nerves at minimum 3 levels of cervical spine, burn will be made at 80° for 60 seconds. Receives: Procedure: Pulsed Radiofrequency Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life measurement: Visual Analogue Scale
Changes in Visual Analogue Scale (VAS), between minimum of zero and maximum of ten
Measured: Beginning of the study , and every 3 months up to 12 months
Quality of life measurement: Neck Disability Index
Changes in the Neck Disability Index - AAOS(NDI_AAOS)
Measured: Beginning of the study , and every 3 months up to 12 months
Quality of life measurement: Short Form Brief Pain Inventory
Changes in the Short Form Brief Pain Inventory (SF-BPI), between minimum of zero and maximum of ten
Measured: Beginning of the study , and every 3 months up to 12 months
Secondary outcomes (14)
At least 30% Changes in Pain Score
Proportion of subjects who achieve at least a 30% decrease in the pain score measured by Visual analogue Scale , between minimum of zero and maximum of ten
Measured: Beginning of the study , and every 3 months up to 12 months
At least 30% Changes in Pain Score
Proportion of subjects who achieve at least a 30% decrease in the pain score measured by Short Form Brief Pain Inventory , between minimum of zero and maximum of ten
Measured: Beginning of the study , and every 3 months up to 12 months
At least 30% Changes in Pain Score
Proportion of subjects who achieve at least a 30% decrease in the pain score measured by The Neck Disability Index , between minimum of zero and maximum of ten
Measured: Beginning of the study , and every 3 months up to 12 months
At least 50% Changes in Pain Score
Proportion of subjects who achieve at least a 50% decrease in the pain score measured by The Neck Disability Index
Measured: Beginning of the study , and every 3 months up to 12 months
At least 50% Changes in Pain Score
Proportion of subjects who achieve at least a 50% decrease in the pain score measured by Short Form Brief Pain Inventory , between minimum of zero and maximum of ten
Measured: Beginning of the study , and every 3 months up to 12 months
At least 50% Changes in Pain Score
Proportion of subjects who achieve at least a 50% decrease in the pain score measured by Visual analogue Scale , between minimum of zero and maximum of ten
Measured: Beginning of the study , and every 3 months up to 12 months
Changes in Changes in Global Improvement and Satisfaction
Changes in Global Improvement and Satisfaction score measured by PGIC
Measured: Beginning of the study , and every 3 months up to 12 months
Changes in The Neck Disability Index
Changes in The Neck Disability Index - AAOS(NDI_AAOS)
Measured: Beginning of the study , and every 3 months up to 12 months
Changes in General Anxiety Disorder Questionnaire
Changes in General Anxiety Disorder Questionnaire (GAD)
Measured: Beginning of the study , and every 3 months up to 12 months
Changes in Beck's Depression Inventory
Changes in Beck's Depression Inventory (BDI)
Measured: Beginning of the study , and every 3 months up to 12 months
Changes in Changes in Patients self-reported perceived duration of effect
Changes in Patients self-reported perceived duration of effect (PSPDE)
Measured: Beginning of the study , and every 3 months up to 12 months
Adverse events
Safety, assessed by the number, severity and duration of adverse reactions. It will be collected as self-rated health-related complaints by the subject and then confirmed medically. The causality will be assigned by the investigator
Measured: Beginning of the study , and every 3 months up to 12 months
Pain Medications
Changes in pain medication use, if it is narcotic, measured by Morphine Equivalent Dose
Measured: Beginning of the study , and every 3 months up to 12 months
Changes in Leeds assessment of neuropathic symptoms and signs
Changes in the Leeds assessment of neuropathic symptoms and signs (LANSS), between minimum of zero and maximum of twenty four
Measured: 6 weeks after RF and if the score was 12 or higher repeat monthly up to 12 weeks
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 start10 Feb 2020
- Primary completion15 Dec 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 (16)Papers the sponsor has linked to this study.
- Other trials for Faceto-genic Neck PainStudies 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
- After performing patient's eligibility for neck RF and receiving information about procedure, patients will be book for two MBB 4-6 weeks apart. If the patient was eligible after the second MBB, Patient will be asked to sign Informed consent before screening. Screening and recruitment, and randomization, patients will be scheduled for one of the RF techniques.
- Masking
- None (open label)
- Enrolment
- 88 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
- NCT04124445
- Sponsor's protocol ID
- 16327-16:325610-06-2019
- Status last verified
- May 2022
- First submitted
- 9 Oct 2019
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results will be published
Publications
Cohen J. Statistical power analysis for the behavioral sciences. 2nd ed. Hillsdale, NJ: L. Erlbaum, 1988.
Falco FJ, Erhart S, Wargo BW, Bryce DA, Atluri S, Datta S, Hayek SM. Systematic review of diagnostic utility and therapeutic effectiveness of cervical facet joint interventions. Pain Physician. 2009 Mar-Apr;12(2):323-44.
PubMed 19305483Yin W, Bogduk N. The nature of neck pain in a private pain clinic in the United States. Pain Med. 2008 Mar;9(2):196-203. doi: 10.1111/j.1526-4637.2007.00369.x.
PubMed 18298702Gil Faclier, Joseph Kay. Cervical facet radiofrequency neurotomy. Techniques in Regional Anesthesia and Pain Management Volume 4, Issue 3, July 2000, Pages 120-125
Smith AD, Jull G, Schneider G, Frizzell B, Hooper RA, Sterling M. Cervical radiofrequency neurotomy reduces central hyperexcitability and improves neck movement in individuals with chronic whiplash. Pain Med. 2014 Jan;15(1):128-41. doi: 10.1111/pme.12262. Epub 2013 Oct 18.
PubMed 24138594Bogduk N, Govind J. Cervicogenic headache: an assessment of the evidence on clinical diagnosis, invasive tests, and treatment. Lancet Neurol. 2009 Oct;8(10):959-68. doi: 10.1016/S1474-4422(09)70209-1.
PubMed 19747657Chang MC. Effect of bipolar pulsed radiofrequency on refractory chronic cervical radicular pain: A report of two cases. Medicine (Baltimore). 2017 Apr;96(15):e6604. doi: 10.1097/MD.0000000000006604.
PubMed 28403104Gazelka HM, Knievel S, Mauck WD, Moeschler SM, Pingree MJ, Rho RH, Lamer TJ. Incidence of neuropathic pain after radiofrequency denervation of the third occipital nerve. J Pain Res. 2014 Apr 10;7:195-8. doi: 10.2147/JPR.S60925. eCollection 2014.
PubMed 24748815Husted DS, Orton D, Schofferman J, Kine G. Effectiveness of repeated radiofrequency neurotomy for cervical facet joint pain. J Spinal Disord Tech. 2008 Aug;21(6):406-8. doi: 10.1097/BSD.0b013e318158971f.
PubMed 18679094Govind J, King W, Bailey B, Bogduk N. Radiofrequency neurotomy for the treatment of third occipital headache. J Neurol Neurosurg Psychiatry. 2003 Jan;74(1):88-93. doi: 10.1136/jnnp.74.1.88.
PubMed 12486273MacVicar J, Borowczyk JM, MacVicar AM, Loughnan BM, Bogduk N. Cervical medial branch radiofrequency neurotomy in New Zealand. Pain Med. 2012 May;13(5):647-54. doi: 10.1111/j.1526-4637.2012.01351.x. Epub 2012 Mar 28.
PubMed 22458772Fang L, Tao W, Jingjing L, Nan J. Comparison of High-voltage- with Standard-voltage Pulsed Radiofrequency of Gasserian Ganglion in the Treatment of Idiopathic Trigeminal Neuralgia. Pain Pract. 2015 Sep;15(7):595-603. doi: 10.1111/papr.12227. Epub 2014 Jun 23.
PubMed 24954016Erdine S, Ozyalcin NS, Cimen A, Celik M, Talu GK, Disci R. Comparison of pulsed radiofrequency with conventional radiofrequency in the treatment of idiopathic trigeminal neuralgia. Eur J Pain. 2007 Apr;11(3):309-13. doi: 10.1016/j.ejpain.2006.04.001. Epub 2006 Jun 9.
PubMed 16762570Cohen 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 26447705Vanelderen P, Rouwette T, De Vooght P, Puylaert M, Heylen R, Vissers K, Van Zundert J. Pulsed radiofrequency for the treatment of occipital neuralgia: a prospective study with 6 months of follow-up. Reg Anesth Pain Med. 2010 Mar-Apr;35(2):148-51. doi: 10.1097/aap.0b013e3181d24713.
PubMed 20301822
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed vs Continuous Radiofrequency Neurotomy for Cervical Facet Joint Mediated Pain: a Single-blind Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04124445
- Acronym / sponsor ID
- 16327-16:325610-06-2019
- Keywords
- Faceto-genic Cervical pain, Chronic pain, Pulsed Radiofrequency ablation, Continues Radiofrequency ablation, Medial Brunch Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Allevio Pain Management ClinicUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 15 Dec 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.
Different studies have revealed different success rates and patient satisfaction after cervical facet C-RF. In a study on 32 patients, with 15 months follow up, 25% had complete pain relief (8). Another study had shown mean pain relief of 12.5 months and 11.5 months following a repeat procedure, with an effectiveness of 95% in 47 patients (8). In one study a success rate of 88% after first RF, and 86% following a repeat RF in 49 patients with facet mediated cervicogenic headache. They regarded the absence of anesthesia in the distribution of the 3rd occipital nerve, a technical failure (9). In a study from New Zealand, demonstrated cervical facet RF as the sole treatment modality, produced 61% -74% complete pain relief with a median duration of 15-17 months in patients who had responded to facet joints diagnostic block (10).
One more study in 2012 has demonstrated high voltage P-RF had a higher short-term effect compare to usual voltage, but results are still lower than C-RF (11). A double blind randomized prospective study has illustrated P-RF did not show any success rate in 6 months pain control, whereas C-RF had 95% pain control for trigeminal neuralgia (12).
Cohen in a recent study has compared P-RF with steroid injection for occipital neuralgia or migraine with occipital nerve tenderness (13). Six weeks pain relief was 61% in P-RF group, and 36% in steroid injection group, with a positive outcome of 34%, and 26% respectively (13). One study on 2010 had reached to 52.6%, 6 months pain improvement on occipital neuralgia (14).
Detailed description
Patients fulfilling eligibility criteria will be randomly allocated to PRF or CRF in a 1:1 ratio. The statistician will use RedCap software to generate random numbers. Patients will be registered to Redcap software and will be concealed from both patients and health care staff. The study coordinator will enter patients' consent and study eligibility information to the Redcap. Once eligible, the Redcap will assign the patient to one of the study group. Patients will be blinded in the proposed study. The assessor is the person who will assess treatment success at the end of the study based on data from completed questionnaires. Questionnaires will be completed every three months by patients through RedCap System. A therapist is the person who will perform the procedure (pain specialist physician). The therapist will not be blinded, because of the nature of intervention.
Patient recruitment is estimated to be completed within 15-24 months. If the required sample size (calculated below) is recruited prior to this time, patient recruitment will be curtailed.
During the first visit the investigator will perform eligibility for neck RF and patient will be received information about the study.
Patients will be book for two MBB 4-6 weeks apart. If the patient was eligible after the second MBB, Patient will be asked to sign Informed consent before screening. Screening and recruitment, and randomization, and administer questionnaires will be performed by research co-ordinator. 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 RF.
For the female subjects between the age of 18-50 a pregnancy test will be asked to obtain on screening visit in order to reduce the risk of pregnancy and potential harm to fetus, unless you had previous tubal ligation, or hysterectomy. Post menopause patients are excluded.
Participants will be asked to complete the follow-up questionnaires at 1, 3, 6, 9, and 12 months.
LANSS questionnaire will be asked to be completed 6 weeks after RF. If the score was 12 or higher, patient will be asked to complete them every 4 weeks after till the score reduce to less than 12. LANSS will be sent to the subjects through RedCap software.
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
- None (open label)
- Number of arms
- 2
- Model description
- After performing patient's eligibility for neck RF and receiving information about procedure, patients will be book for two MBB 4-6 weeks apart. If the patient was eligible after the second MBB, Patient will be asked to sign Informed consent before screening. Screening and recruitment, and randomization, patients will be scheduled for one of the RF techniques.
| Arm | Type | Receives |
|---|---|---|
| Pulsed Radiofrequency Ablation | Active comparator | Procedure: Pulsed Radiofrequency AblationRadiofrequency ablation of sensory nerves at minimum 3 levels of cervical spine with Maximum allowable temperature 50° rotation: 90.; Pulse rate: 3 Hz; pulse duration: 50 ms; 3 minutes |
| Continuous Radiofrequency Ablation | Active comparator | Procedure: Pulsed Radiofrequency AblationRadiofrequency ablation of sensory nerves at minimum 3 levels of cervical spine, burn will be made at 80° for 60 seconds. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-90;
- Pain duration > 3 months
- Cervical, Shoulder pain or cevicogenic Headache per Pain Diagram;
- Two single blinded facet medial branch blocks (MBB) performed 30 days prior to the facet RF;
- Subjects show 50% and more pain relief after each MBB (using VAS for this assessment);
Key exclusion criteria (8 listed)
- Non-English speakers;
- Refusal to sign informed consent;
- Less than 50% pain relief after MBB (using VAS);
- Variation in the dose of concomitant pain control medication less than 4 weeks before the procedure;
- Allergy to medication or radiology contrast;
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 |
|---|---|---|
| Pulsed Radiofrequency AblationAlso: Continuous Radiofrequency AblationRadiofrequency ablation, also called rhizotomy, is a nonsurgical, minimally invasive procedure that uses heat to reduce or stop the transmission of pain. Radiofrequency waves ablate, or "burn," the nerve that is causing the pain, essentially eliminating the transmission of pain signals to the brain. | Procedure or surgery | Continuous Radiofrequency Ablation, Pulsed Radiofrequency Ablation |
Primary outcome
Quality of life measurement: Visual Analogue Scale
Time frame: Beginning of the study , and every 3 months up to 12 months
Changes in Visual Analogue Scale (VAS), between minimum of zero and maximum of ten
Quality of life measurement: Neck Disability Index
Time frame: Beginning of the study , and every 3 months up to 12 months
Changes in the Neck Disability Index - AAOS(NDI_AAOS)
Quality of life measurement: Short Form Brief Pain Inventory
Time frame: Beginning of the study , and every 3 months up to 12 months
Changes in the Short Form Brief Pain Inventory (SF-BPI), between minimum of zero and maximum of ten
14 secondary outcomes
At least 30% Changes in Pain Score
Time frame: Beginning of the study , and every 3 months up to 12 months
At least 30% Changes in Pain Score
Time frame: Beginning of the study , and every 3 months up to 12 months
At least 30% Changes in Pain Score
Time frame: Beginning of the study , and every 3 months up to 12 months
At least 50% Changes in Pain Score
Time frame: Beginning of the study , and every 3 months up to 12 months
At least 50% Changes in Pain Score
Time frame: Beginning of the study , and every 3 months up to 12 months
At least 50% Changes in Pain Score
Time frame: Beginning of the study , and every 3 months up to 12 months
Changes in Changes in Global Improvement and Satisfaction
Time frame: Beginning of the study , and every 3 months up to 12 months
Changes in The Neck Disability Index
Time frame: Beginning of the study , and every 3 months up to 12 months
Changes in General Anxiety Disorder Questionnaire
Time frame: Beginning of the study , and every 3 months up to 12 months
Changes in Beck's Depression Inventory
Time frame: Beginning of the study , and every 3 months up to 12 months
Changes in Changes in Patients self-reported perceived duration of effect
Time frame: Beginning of the study , and every 3 months up to 12 months
Adverse events
Time frame: Beginning of the study , and every 3 months up to 12 months
Pain Medications
Time frame: Beginning of the study , and every 3 months up to 12 months
Changes in Leeds assessment of neuropathic symptoms and signs
Time frame: 6 weeks after RF and if the score was 12 or higher repeat monthly up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- BackgroundCohen J. Statistical power analysis for the behavioral sciences. 2nd ed. Hillsdale, NJ: L. Erlbaum, 1988.
- Results publication: PubMed 19305483Falco FJ, Erhart S, Wargo BW, Bryce DA, Atluri S, Datta S, Hayek SM. Systematic review of diagnostic utility and therapeutic effectiveness of cervical facet joint interventions. Pain Physician. 2009 Mar-Apr;12(2):323-44.
- Results publication: PubMed 18298702Yin W, Bogduk N. The nature of neck pain in a private pain clinic in the United States. Pain Med. 2008 Mar;9(2):196-203. doi: 10.1111/j.1526-4637.2007.00369.x.
- Results publicationGil Faclier, Joseph Kay. Cervical facet radiofrequency neurotomy. Techniques in Regional Anesthesia and Pain Management Volume 4, Issue 3, July 2000, Pages 120-125
- Results publication: PubMed 24138594Smith AD, Jull G, Schneider G, Frizzell B, Hooper RA, Sterling M. Cervical radiofrequency neurotomy reduces central hyperexcitability and improves neck movement in individuals with chronic whiplash. Pain Med. 2014 Jan;15(1):128-41. doi: 10.1111/pme.12262. Epub 2013 Oct 18.
- Results publication: PubMed 19747657Bogduk N, Govind J. Cervicogenic headache: an assessment of the evidence on clinical diagnosis, invasive tests, and treatment. Lancet Neurol. 2009 Oct;8(10):959-68. doi: 10.1016/S1474-4422(09)70209-1.
- Results publication: PubMed 28403104Chang MC. Effect of bipolar pulsed radiofrequency on refractory chronic cervical radicular pain: A report of two cases. Medicine (Baltimore). 2017 Apr;96(15):e6604. doi: 10.1097/MD.0000000000006604.
- Results publication: PubMed 24748815Gazelka HM, Knievel S, Mauck WD, Moeschler SM, Pingree MJ, Rho RH, Lamer TJ. Incidence of neuropathic pain after radiofrequency denervation of the third occipital nerve. J Pain Res. 2014 Apr 10;7:195-8. doi: 10.2147/JPR.S60925. eCollection 2014.
- Results publication: PubMed 18679094Husted DS, Orton D, Schofferman J, Kine G. Effectiveness of repeated radiofrequency neurotomy for cervical facet joint pain. J Spinal Disord Tech. 2008 Aug;21(6):406-8. doi: 10.1097/BSD.0b013e318158971f.
- Results publication: PubMed 12486273Govind J, King W, Bailey B, Bogduk N. Radiofrequency neurotomy for the treatment of third occipital headache. J Neurol Neurosurg Psychiatry. 2003 Jan;74(1):88-93. doi: 10.1136/jnnp.74.1.88.
- Results publication: PubMed 22458772MacVicar J, Borowczyk JM, MacVicar AM, Loughnan BM, Bogduk N. Cervical medial branch radiofrequency neurotomy in New Zealand. Pain Med. 2012 May;13(5):647-54. doi: 10.1111/j.1526-4637.2012.01351.x. Epub 2012 Mar 28.
- Results publication: PubMed 24954016Fang L, Tao W, Jingjing L, Nan J. Comparison of High-voltage- with Standard-voltage Pulsed Radiofrequency of Gasserian Ganglion in the Treatment of Idiopathic Trigeminal Neuralgia. Pain Pract. 2015 Sep;15(7):595-603. doi: 10.1111/papr.12227. Epub 2014 Jun 23.
- Individual participant dataSharing planned: No. Results will be published
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Radiofrequency Ablation in people with Faceto-genic Neck Pain and Shoulder Pain Chronic, run by Allevio Pain Management Clinic at 2 sites in Canada.
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 8 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 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life measurement: Visual Analogue Scale (time frame: Beginning of the study , and every 3 months up to 12 months). The study lists 3 primary outcomes in all. 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 NCT04124445, which also lists 16 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 23 Jun 2022.