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

Continuous Versus Combined Continuous and Pulsed Radiofrequency Ablation for Pain Relief and Safety in Cervical Facet-Mediated Pain: A Prospective Randomized Study

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

One prevalent and incapacitating problem seen in pain treatment therapy is chronic neck pain originating from the cervical facet joints. (1). Cervical facet joint pain was shown to be 49% common in a recent study (2). Depending on the level of the cervical facet joint, a facet referral pattern is characteristic of cervical facet joint discomfort (3,4). Radiofrequency (RF) ablation of the medial branch nerves is a proven, minimally invasive therapeutic option for long-lasting pain alleviation once a good response to diagnostic cervical medial branch blocks validates the diagnosis. Cervical facet joint pain has been successfully treated with traditional continuous radiofrequency ablation (RFA) of the cervical medial branches (5). Regretfully, even with sufficient analgesia, over 40% of patients undergoing RFA experience negative side effects, including post-procedural sensory side effects like numbness, dysesthesia, and hypersensitivity. 6,7). As a result, Continuous radiofrequency ablation (CRF) is the established minimally invasive treatment for chronic facet-mediated spinal pain once diagnostic medial branch blocks confirm the pain source, producing a thermal lesion at the target nerve to interrupt nociceptive transmission. Manchikanti et al. rated continuous RFA as Level II evidence for managing chronic spinal pain from the facet joints, reflecting its established role in clinical practice (6). However, despite its efficacy, more than 40% of patients undergoing CRF of the cervical medial branches experience post-procedural sensory side effects such as numbness, dysesthesia, and hypersensitivity (7,8) prompting interest in alternative radiofrequency strategies that preserve analgesic benefit while reducing these neuropathic effects. Combining continuous and pulsed radiofrequency (CPRF) has been proposed as a strategy to preserve the analgesic effect achieved with thermal ablation while reducing the incidence of post-procedural neuropathic side effects through the added neuromodulatory pulsed phase (9). However, there are no studies comparing the effectiveness and safety of pulse versus combined radiofrequency ablation in the cervical facet joint. This study was designed to compare the effectiveness and safety of continuous radiofrequency (CRF) alone versus combined continuous and pulsed radiofrequency (CPRF) in patients with chronic cervical facet joint pain.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Al Fayyum, 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.
• American Society of Anesthesiologists (ASA) physical status class I or II
• ≥ 4 points on the verbal numeric rating scale (VNRS) (scored from 0 = no pain to 100 = worst pain imaginable)) before RF stimulation of the cervical medial branches;
• Patients presenting with a 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.	6 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
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.	12 months
VAS SCORE	of procedure, visual analog scale (VAS;0-100)	One month
VAS SCORE	of procedure, visual analog scale (VAS;0-100)	3 months
VAS SCORE	of procedure, visual analog scale (VAS;0-100)	12 months
VAS SCORE	of procedure, visual analog scale (VAS;0-100)	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	in years	1 hour before procedure
Weight	in Kilogram	1 hour before procedure
Height	in centimeter	1 hour before procedure
Body mass index	in kilogram/m2	1 hour before procedure

Collaborators and Investigators

• Sponsor: Fayoum University Hospital
• Investigators: Principal Investigator: Atef M Sayed, MD, Fayoum University

Publications and helpful links

General Publications

• Manchikanti L, Kaye AD, Boswell MV, Bakshi S, Gharibo CG, Grami V, Grider JS, Gupta S, Jha SS, Mann DP, Nampiaparampil DE, Sharma ML, Shroyer LN, Singh V, Soin A, Vallejo R, Wargo BW, Hirsch JA. A Systematic Review and Best Evidence Synthesis of the Effectiveness of Therapeutic Facet Joint Interventions in Managing Chronic Spinal Pain. Pain Physician. 2015 Jul-Aug;18(4):E535-82.
• Ojeda Nino A, Manterola Lasa O, Gracia Fabre C, Nebreda-Clavo CL, Ferreira-Dos-Santos G, Armand-Ugon R. Dropped head syndrome after bilateral cervical radiofrequency ablation. A case report and literature review. Interv Pain Med. 2024 Apr 16;3(2):100409. doi: 10.1016/j.inpm.2024.100409. eCollection 2024 Jun.
• Barnsley L, Lord S, Bogduk N. Comparative local anaesthetic blocks in the diagnosis of cervical zygapophysial joint pain. Pain. 1993 Oct;55(1):99-106. doi: 10.1016/0304-3959(93)90189-V.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): February 1, 2024

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): September 23, 2026
• Last Update Submitted That Met QC Criteria: September 18, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Neck pain; Radiofrequency ablation; medial branch
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neck Pain
• 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