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Pulsed vs Continuous Radiofrequency Neurotomy for Cervical Facet Joint Mediated Pain

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ClinicalTrials.gov Identifier: NCT04124445
Recruitment Status : Not yet recruiting
First Posted : October 11, 2019
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Allevio Pain Management Clinic

Tracking Information
First Submitted Date  ICMJE October 9, 2019
First Posted Date  ICMJE October 11, 2019
Last Update Posted Date October 11, 2019
Estimated Study Start Date  ICMJE December 10, 2019
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2019)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2019)
  • At least 30% Changes in Pain Score [ Time Frame: Beginning of the study , and every 3 months up to 12 months ]
    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 [ Time Frame: Beginning of the study , and every 3 months up to 12 months ]
    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 [ Time Frame: Beginning of the study , and every 3 months up to 12 months ]
    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 [ Time Frame: Beginning of the study , and every 3 months up to 12 months ]
    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 [ Time Frame: Beginning of the study , and every 3 months up to 12 months ]
    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 [ Time Frame: Beginning of the study , and every 3 months up to 12 months ]
    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 [ Time Frame: Beginning of the study , and every 3 months up to 12 months ]
    Changes in Global Improvement and Satisfaction score measured by PGIC
  • Changes in The 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)
  • Changes in General Anxiety Disorder Questionnaire [ Time Frame: Beginning of the study , and every 3 months up to 12 months ]
    Changes in General Anxiety Disorder Questionnaire (GAD)
  • Changes in Beck's Depression Inventory [ Time Frame: Beginning of the study , and every 3 months up to 12 months ]
    Changes in Beck's Depression Inventory (BDI)
  • 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 ]
    Changes in Patients self-reported perceived duration of effect (PSPDE)
  • Adverse events [ Time Frame: Beginning of the study , and every 3 months up to 12 months ]
    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 [ Time Frame: Beginning of the study , and every 3 months up to 12 months ]
    Changes in pain medication use, if it is narcotic, measured by Morphine Equivalent Dose
  • 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 ]
    Changes in the Leeds assessment of neuropathic symptoms and signs (LANSS), between minimum of zero and maximum of twenty four
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pulsed vs Continuous Radiofrequency Neurotomy for Cervical Facet Joint Mediated Pain
Official Title  ICMJE Pulsed vs Continuous Radiofrequency Neurotomy for Cervical Facet Joint Mediated Pain: a Single-blind Randomized Controlled Clinical Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Condition  ICMJE Chronic Cervical Faceto-genic Pain, Including Shoulder Pain and Cervicogenic Headache
Intervention  ICMJE Procedure: Pulsed 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.
Other Name: Continuous Radiofrequency Ablation
Study Arms  ICMJE
  • Active Comparator: Pulsed Radiofrequency Ablation
    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
    Intervention: Procedure: Pulsed Radiofrequency Ablation
  • Active Comparator: Continuous Radiofrequency Ablation
    Radiofrequency ablation of sensory nerves at minimum 3 levels of cervical spine, burn will be made at 80° for 60 seconds.
    Intervention: Procedure: Pulsed Radiofrequency Ablation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 10, 2019)
88
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2023
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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);

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04124445
Other Study ID Numbers  ICMJE 16327-16:325610-06-2019
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Results will be published
Responsible Party Allevio Pain Management Clinic
Study Sponsor  ICMJE Allevio Pain Management Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Allevio Pain Management Clinic
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP