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Pulsed vs Continuous Radiofrequency Neurotomy for Cervical Facet Joint Mediated Pain

Primary Purpose

Faceto-genic Neck Pain, Shoulder Pain Chronic, Faceto-genic Headache

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Pulsed Radiofrequency Ablation
Sponsored by
Allevio Pain Management Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Faceto-genic Neck Pain focused on measuring Faceto-genic Cervical pain, Chronic pain, Pulsed Radiofrequency ablation, Continues Radiofrequency ablation, Medial Brunch Block

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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;

Exclusion Criteria:

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);

Sites / Locations

  • Allevio Pain Management ClinicRecruiting
  • Allevio Pain ManagementRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pulsed Radiofrequency Ablation

Continuous Radiofrequency Ablation

Arm Description

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

Radiofrequency ablation of sensory nerves at minimum 3 levels of cervical spine, burn will be made at 80° for 60 seconds.

Outcomes

Primary Outcome Measures

Quality of life measurement: Visual Analogue Scale
Changes in Visual Analogue Scale (VAS), between minimum of zero and maximum of ten
Quality of life measurement: Neck Disability Index
Changes in the Neck Disability Index - AAOS(NDI_AAOS)
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

Secondary Outcome Measures

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
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
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
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
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
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
Changes in Changes in Global Improvement and Satisfaction
Changes in Global Improvement and Satisfaction score measured by PGIC
Changes in The Neck Disability Index
Changes in The Neck Disability Index - AAOS(NDI_AAOS)
Changes in General Anxiety Disorder Questionnaire
Changes in General Anxiety Disorder Questionnaire (GAD)
Changes in Beck's Depression Inventory
Changes in Beck's Depression Inventory (BDI)
Changes in Changes in Patients self-reported perceived duration of effect
Changes in Patients self-reported perceived duration of effect (PSPDE)
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
Pain Medications
Changes in pain medication use, if it is narcotic, measured by Morphine Equivalent Dose
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

Full Information

First Posted
October 9, 2019
Last Updated
June 22, 2022
Sponsor
Allevio Pain Management Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04124445
Brief Title
Pulsed vs Continuous Radiofrequency Neurotomy for Cervical Facet Joint Mediated Pain
Official Title
Pulsed vs Continuous Radiofrequency Neurotomy for Cervical Facet Joint Mediated Pain: a Single-blind Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2020 (Actual)
Primary Completion Date
December 15, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allevio Pain Management Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Faceto-genic Neck Pain, Shoulder Pain Chronic, Faceto-genic Headache
Keywords
Faceto-genic Cervical pain, Chronic pain, Pulsed Radiofrequency ablation, Continues Radiofrequency ablation, Medial Brunch Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pulsed Radiofrequency Ablation
Arm Type
Active Comparator
Arm Description
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
Arm Title
Continuous Radiofrequency Ablation
Arm Type
Active Comparator
Arm Description
Radiofrequency ablation of sensory nerves at minimum 3 levels of cervical spine, burn will be made at 80° for 60 seconds.
Intervention Type
Procedure
Intervention Name(s)
Pulsed Radiofrequency Ablation
Other Intervention Name(s)
Continuous Radiofrequency Ablation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of life measurement: Visual Analogue Scale
Description
Changes in Visual Analogue Scale (VAS), between minimum of zero and maximum of ten
Time Frame
Beginning of the study , and every 3 months up to 12 months
Title
Quality of life measurement: Neck Disability Index
Description
Changes in the Neck Disability Index - AAOS(NDI_AAOS)
Time Frame
Beginning of the study , and every 3 months up to 12 months
Title
Quality of life measurement: Short Form Brief Pain Inventory
Description
Changes in the Short Form Brief Pain Inventory (SF-BPI), between minimum of zero and maximum of ten
Time Frame
Beginning of the study , and every 3 months up to 12 months
Secondary Outcome Measure Information:
Title
At least 30% Changes in Pain Score
Description
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
Time Frame
Beginning of the study , and every 3 months up to 12 months
Title
At least 30% Changes in Pain Score
Description
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
Time Frame
Beginning of the study , and every 3 months up to 12 months
Title
At least 30% Changes in Pain Score
Description
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
Time Frame
Beginning of the study , and every 3 months up to 12 months
Title
At least 50% Changes in Pain Score
Description
Proportion of subjects who achieve at least a 50% decrease in the pain score measured by The Neck Disability Index
Time Frame
Beginning of the study , and every 3 months up to 12 months
Title
At least 50% Changes in Pain Score
Description
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
Time Frame
Beginning of the study , and every 3 months up to 12 months
Title
At least 50% Changes in Pain Score
Description
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
Time Frame
Beginning of the study , and every 3 months up to 12 months
Title
Changes in Changes in Global Improvement and Satisfaction
Description
Changes in Global Improvement and Satisfaction score measured by PGIC
Time Frame
Beginning of the study , and every 3 months up to 12 months
Title
Changes in The Neck Disability Index
Description
Changes in The Neck Disability Index - AAOS(NDI_AAOS)
Time Frame
Beginning of the study , and every 3 months up to 12 months
Title
Changes in General Anxiety Disorder Questionnaire
Description
Changes in General Anxiety Disorder Questionnaire (GAD)
Time Frame
Beginning of the study , and every 3 months up to 12 months
Title
Changes in Beck's Depression Inventory
Description
Changes in Beck's Depression Inventory (BDI)
Time Frame
Beginning of the study , and every 3 months up to 12 months
Title
Changes in Changes in Patients self-reported perceived duration of effect
Description
Changes in Patients self-reported perceived duration of effect (PSPDE)
Time Frame
Beginning of the study , and every 3 months up to 12 months
Title
Adverse events
Description
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
Time Frame
Beginning of the study , and every 3 months up to 12 months
Title
Pain Medications
Description
Changes in pain medication use, if it is narcotic, measured by Morphine Equivalent Dose
Time Frame
Beginning of the study , and every 3 months up to 12 months
Title
Changes in Leeds assessment of neuropathic symptoms and signs
Description
Changes in the Leeds assessment of neuropathic symptoms and signs (LANSS), between minimum of zero and maximum of twenty four
Time Frame
6 weeks after RF and if the score was 12 or higher repeat monthly up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; Exclusion Criteria: 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);
Facility Information:
Facility Name
Allevio Pain Management Clinic
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3B 3S6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramin Safakish, MD. FRCPC
Phone
6474788462
Email
Ramin.Safakish@AllevioClinic.com
First Name & Middle Initial & Last Name & Degree
Shadi Babazadeh, MD
Phone
6474788462
Ext
Safakish
Email
Shadi.Babazadeh@AllevioClinic.com
First Name & Middle Initial & Last Name & Degree
Ramin Safakish, MD. FRCPC
First Name & Middle Initial & Last Name & Degree
Gil Faclier, MD. FRCPC
First Name & Middle Initial & Last Name & Degree
Imrat Sohanpal, MD. FRCPC
First Name & Middle Initial & Last Name & Degree
Shadi Babazadeh, MD
First Name & Middle Initial & Last Name & Degree
Andriy Strilchuk, MD. NP
Facility Name
Allevio Pain Management
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3B 3S6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramin Safakish, MD, FRCPC
Phone
6474788462
Email
Ramin.Safakish@allevioclinic.com
First Name & Middle Initial & Last Name & Degree
Imrat Sohanpal, MD, FRCPC
Phone
6474788462
Email
Imrat.Sohanpal@allevioclinic.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Results will be published
Citations:
Citation
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Pulsed vs Continuous Radiofrequency Neurotomy for Cervical Facet Joint Mediated Pain

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