CClinicalTrials.gg
CompletedNCT05719948Updated Sep 23, 2026

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

An interventional study of Flouroscopic guidance cervical medial branch radiofrequency ablation in Radiofrequency Ablation, sponsored by Fayoum University Hospital. Completed at 1 site in Egypt. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Fayoum University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Oct 2021, registered Nov 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
39
Allocation
Randomized
Ages
30 Years to 75 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Radiofrequency Ablation

Browse trials for

Keywords

  • medial branch
  • Neck pain
  • Radiofrequency ablation
03

In context

Neck Pain

1,232 studies on the registry are indexed under Neck Pain; 254 are open to participants now.

This study's enrollment of 39 is below the median of 52 across 1,004 interventional studies indexed under Neck Pain.

Browse Neck Pain studies →

Lead sponsor

Fayoum University Hospital is the lead sponsor of 73 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
39 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • ProcedureFlouroscopic guidance cervical medial branch radiofrequency ablation

    Electromagnetic wave deposition near nerve tissue for pain management

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

Secondary outcomes

  1. 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

    Time frame: One month, 3months,6 months, 12 months

  2. Complications

    Numbness, dysethesia, drop head syndrome, hypersensitivity, ataxia

    Time frame: One month, 3 months, 6months, 12 months

  3. 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.

    Time frame: One month

  4. 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.

    Time frame: 3 months

  5. 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.

    Time frame: 12 months

  6. VAS SCORE

    of procedure, visual analog scale (VAS;0-100)

    Time frame: One month

  7. VAS SCORE

    of procedure, visual analog scale (VAS;0-100)

    Time frame: 3 months

  8. VAS SCORE

    of procedure, visual analog scale (VAS;0-100)

    Time frame: 12 months

  9. VAS SCORE

    of procedure, visual analog scale (VAS;0-100)

    Time frame: 6 months

Other outcomes

  1. Age

    in years

    Time frame: 1 hour before procedure

  2. Weight

    in Kilogram

    Time frame: 1 hour before procedure

  3. Height

    in centimeter

    Time frame: 1 hour before procedure

  4. Body mass index

    in kilogram/m2

    Time frame: 1 hour before procedure

07

Study locations

1 site
  • Atef Mohamed mahmoud
    Al Fayyum, 63512, Egypt
08

References and documents

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. PubMed 26218948 ↗
  • 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. PubMed 39238580 ↗
  • 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. PubMed 8278215 ↗

Individual participant data

Plan to share: No — Data will be given on resonable request

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05719948
Lead sponsor
Fayoum University Hospital
Responsible party
Atef Mohamed mahmoud (Associate professor, Fayoum University Hospital) — Principal investigator
First posted
Feb 9, 2023
Start date
Oct 1, 2021
Primary completion
Feb 1, 2024
Completion
Feb 1, 2024
Last update
Sep 23, 2026

Study contacts

Atef M Sayed, MD
principal investigator · Fayoum University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion