Combined Continuous and Pulsed Radiofrequency Ablation for Pain Relief and Their Safety in Cervical Facet Pain

Continuous radiofrequency ablation (CRF) is the effective management for cervical facet joint pain but related with neuropathic symptoms in post-radiofrequency period. Additionally, pulse radiofrequency ablation (PRF) provides relief of neuropathic symptoms. However, the effect of CRF followed by PRF has yet to be validated

Study Overview

• Status: Completed
• Conditions: Radiofrequency Ablation
• Intervention / Treatment: Procedure: Flouroscopic guidance cervical medial branch radiofrequency ablation

Detailed Description

Diagnostic procedure symptomatic facet joint was designated according to pain referral. Also, medial branches were injected with 2% lidocaine 0.3 ml per site.

Treatment procedure The posterior technique was first described in 1995 . All interventions assessed the intravenous saline lock on arrival at the outpatient department using pulse oximetry and noninvasive blood pressure monitoring and intravenous sedation as required. Patients were assigned in a prone position under C-ARM fluoroscopic guidance with a Neurotherm NT 2000 Lesion Generator the (USA manufactured) . The electrode pad of the radiofrequency equipment was attached to the ipsilateral side of the posterior thigh. After the skin was then anesthetized with 1% lidocaine, a 20-gauge, 10-cm cannula with 10-mm curved active tip (Diros RF Cannula, Diros Technology Inc., Canada) was inserted along a 15 to 30 degree angle to the sagittal plane (slightly posterior oblique approach) . The cannula was applied until reaching the lateral part of the articular pillar . Then the depth of the cannula was checked using a lateral view. A probe was inserted through the cannula and linked to a radiofrequency generator (Diros Technology OWL, Canada). After impedance were accomplished at below 500 Ohm, sensory stimulation was performed at 50 Hz and the patient reported not feeling any tingling sensation along the distribution of dermatome. Consequently, a motor stimulation (2 Hz) was executed until multifidus twitching was presented at stimulation less than 1 volts and no motor twitching was observed along the myotome. A non-ionic contrast medium was injected to ensure the intravascular injection before 1% lidocaine 0.5 ml was injected after the needle reached the desired location. The study investigated two lesions due to the anatomical variation of the medial branches. Patients in the CRF group (n = 16) underwent CRF at 80°C for 90 seconds for 2 cycles. Patients in the CPRF group underwent CRF at 80°C for 90 seconds for 1 cycle followed by PRF at 42°C for 120 seconds for 1 cycle. 0.125% bupivacaine plus 2 mg of dexamethasone in a total volume of 1 mL were injected after lesioning had performed.

Measurement The demographic data including age, sex, comorbidities, body mass index (BMI), level of procedure, visual analog scale (VAS;1-100) Neck Pain Disability Index and complications were reviewed. It contains ten sectors: seven sectors related to everyday existing behaviors, two sectors correlated to pain, and one sector correlated to concentration. All items are marked from 0 to 5. A mark of 0 denotes the maximum level of function, while a mark of 5 indicates the bottom level of function. The maximum mark is 50, and a greater mark relates to an increased level of disability. The NDI scores were recorded before intervention and first month, third month, sixth month, ninth months and 12 months after intervention. The follow-up was performed either face to face or by phone, and patients were not permitted to use over-the counter analgesic medication. The primary outcome was number of patients who had successful treatment, expressed as at least 80% pain relief from baseline and NDI score less than 15 for at least 3 months . The secondary outcomes comprised the duration of pain relief defined as the time of pain relief until VAS had restored to at least 50% from baseline and side effects including numbness, ataxia, dysesthesia, hypersensitivity, itching and muscular weakness (dropped head syndrome) between group comparisons. A research assistant, who was uninvolved in the intervention or post-operative follow-up, collected all data in prospective medical records.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Fayoum, Egypt, 63512
    • Atef Mohamed mahmoud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients age from (30-75) years old.
• ASA ( I, II).
• Patients presenting positive diagnostic cervical medial branche block defined as pain relief more than 50% from baseline.

Exclusion Criteria:

• Repeated cervical radiofrequency ablation.
• Patients presenting neck pain with radicular symptoms.
• Previous cervical discectomy or fixation surgery.
• Malignancy.
• local infection
• Psychological problem.
• language barrier.
• History of allergy to radio-opaque contrast solution,lidocaine or bupivacaine. - Inadequate medical proplem (hepatic, renal, cardiac) patients.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Flouroscopic guidance cervical medial branch continous RF ablation; After the patient lying prone we obtaining the posterior approach with PA view then lateral 15 degrees the C shaped edge of the cervical vertebrae were appeared and then we advance the needle till reaching this C shaped till hitting the bone then slipping the active tip slightly therafter we obtaining lateral view to determine the depth of the needle over the cervical pedicle. patients in the continous radiofrequency group will be underwent continous radiofrequency at 80°C for 90 seconds for 2 cycles	Procedure: Flouroscopic guidance cervical medial branch radiofrequency ablation; Electromagnetic wave deposition near nerve tissue for pain management
Active Comparator: Flouroscopic guidance cervical medial branch combined pulsed and continous RF ablation; After the patient lying prone we obtaining the posterior approach with PA view then lateral 15 degrees the C shaped edge of the cervical vertebrae were appeared and then we advance the needle till reaching this C shaped till hitting the bone then slipping the active tip slightly therafter we obtaining lateral view to determine the depth of the needle over the cervical pedicle. patients in the continous and pulsed group will be underwent continous and pulsed radiofrequency at 80°C for 90 seconds for 1 cycle followed by pulsed radiofrequency at 42°C for 120 seconds for 1 cycle	Procedure: Flouroscopic guidance cervical medial branch radiofrequency ablation; Electromagnetic wave deposition near nerve tissue for pain management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neck disability index pre and post-intervention between comparison groups	Neck disability index : It contains ten sectors: seven sectors related to everyday existing behaviors, two sectors correlated to pain, and one sector correlated to concentration. All items are marked from 0 to 5. A mark of 0 denotes the maximum level of function, while a mark of 5 indicates the bottom level of function. The maximum mark is 50, and a greater mark relates to an increased level of disability.	One month
neck disability index pre and post-intervention between comparison groups	Neck disability index : It contains ten sectors: seven sectors related to everyday existing behaviors, two sectors correlated to pain, and one sector correlated to concentration. All items are marked from 0 to 5. A mark of 0 denotes the maximum level of function, while a mark of 5 indicates the bottom level of function. The maximum mark is 50, and a greater mark relates to an increased level of disability.	3 months
neck disability index pre and post-intervention between comparison groups	Neck disability index : It contains ten sectors: seven sectors related to everyday existing behaviors, two sectors correlated to pain, and one sector correlated to concentration. All items are marked from 0 to 5. A mark of 0 denotes the maximum level of function, while a mark of 5 indicates the bottom level of function. The maximum mark is 50, and a greater mark relates to an increased level of disability.	6 months
neck disability index pre and post-intervention between comparison groups	Neck disability index : It contains ten sectors: seven sectors related to everyday existing behaviors, two sectors correlated to pain, and one sector correlated to concentration. All items are marked from 0 to 5. A mark of 0 denotes the maximum level of function, while a mark of 5 indicates the bottom level of function. The maximum mark is 50, and a greater mark relates to an increased level of disability.	12 months
VAS SCORE	of procedure, visual analog scale (VAS;1-100)	One month
VAS SCORE	of procedure, visual analog scale (VAS;1-100)	3 months
VAS SCORE	of procedure, visual analog scale (VAS;1-100)	6 months
VAS SCORE	of procedure, visual analog scale (VAS;1-100)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of pain relief	The duration of pain relief was expressed as the period between pain relief and pain reoccurrence to 50% of pre-procedural pain level	One month, 3months,6 months, 12 months
Complications	Numbness, dysethesia, drop head syndrome, hypersensitivity, ataxia	One month, 3 months, 6months, 12 months

Collaborators and Investigators

• Sponsor: Fayoum University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: November 24, 2022
• First Submitted That Met QC Criteria: January 30, 2023
• First Posted (Actual): February 9, 2023

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Neck pain; Radiofrequency ablation; medial branch
• Other Study ID Numbers: R 333

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be given on resonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No