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

NCT05719948 | Completed

• 1 other identifier: R 333
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Radiofrequency Ablation

Keywords

medial branch; Neck pain; Radiofrequency ablation

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (2)

• Duration of pain relief

  One month, 3months,6 months, 12 months

• Complications

  One month, 3 months, 6months, 12 months

Study Arms (2)

Flouroscopic guidance cervical medial branch continous RF ablation

ACTIVE COMPARATOR

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

Flouroscopic guidance cervical medial branch combined pulsed and continous RF ablation

ACTIVE COMPARATOR

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

Interventions

Flouroscopic guidance cervical medial branch radiofrequency ablation PROCEDURE

Electromagnetic wave deposition near nerve tissue for pain management

Flouroscopic guidance cervical medial branch combined pulsed and continous RF ablation; Flouroscopic guidance cervical medial branch continous RF ablation

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Atef Mohamed mahmoud

Al Fayyum, 63512, Egypt

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: None of the investigator or outcomees assessor know the intervention used
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: One model recieved continous RF while the other recieved combined pulsed and continous RF.

Study Record Dates

• First Submitted: November 24, 2022
• First Posted: February 9, 2023
• Study Start: October 1, 2020
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)