NCT06695481

Brief Summary

In this study, investigators compared the effectiveness of medial branch conventional radiofrequency application and combined radiofrequency application in patients with lumbar facet joint disease , focusing on pain scores. The combined radiofrequency application, a sequence of pulsed radiofrequency and conventional radiofrequency , has been shown to be successful in treating neck pain and headache. These findings are of significant importance in the field of pain management and spinal disorders.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 19, 2024

Completed
Last Updated

November 19, 2024

Status Verified

July 1, 2024

Enrollment Period

1 month

First QC Date

July 22, 2024

Last Update Submit

November 18, 2024

Conditions

Keywords

Pulsed Radiofrequency TreatmentRadiofrequency Ablation

Outcome Measures

Primary Outcomes (2)

  • Neuropathic Pain Scale

    Neuropathic Pain 4 Questions (DN4)

    Scores of the patients ; before the procedure and 6 and 12 months after the procedure are shownThe 7 symptoms items are scored by interviewing the patient.The scores are added and a score of 4 or more out of ,10 point (severe pain ) .

  • Pain Rating Scale

    Numeric Rating Scale

    The NRS scores of the patients before the procedure and 6 and 12 months after the procedure .NRS in which individuals rate their pain on an ten-point numerical scale. Zero:''no pain at all' ten-point ''severe pain''

Study Arms (2)

Conventional

In this group, only patients who had facet joint medial branch conventional RF applied to the patients who benefited after diagnostic injection into the facet joint were selected.

Procedure: Conventional RF

Combined

This group was selected retrospectively from patients who benefited from diagnostic injection into the facet joint and who underwent pulsed rf in addition to facet joint medial branch conventional rf.

Procedure: Combined RF

Interventions

The conventional RF group consists of patients who received medial branch RF with a duration of 2 minutes, at 80̊ C temperature, and 7 Volts.

Conventional
Combined RFPROCEDURE

In the combined RF group, treatment was initiated first with a conventional RF duration of 2 minutes at a temperature of 80̊ C at 7 Volts. Then, pulsed RF duration was applied for 6 minutes at a temperature of 42 C at 45 Volts, with a pulse frequency of 2 Hz and a width of 20 ms.

Combined

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are clinically diagnosed with lumbar facet joint pain after getting a pain reduction of over 50% following a selective diagnostic block (0.5 ml 2% lidocaine) performed on the facet joint medial branch block and after then RF (cobined or conventional) application under fluoroscopy.

You may qualify if:

  • years of age
  • Patients with low back pain for more than three months and did not respond to conservative treatment

You may not qualify if:

  • Patients who underwent facet joint medial branch RF treatment previously
  • Patients had additional interventional pain treatment or lumbar surgery within one year of the procedure
  • Patients had radicular and significant disc pathology, psychiatric diseases or mental problems, malignancies
  • Patients of one year follow-up could not be assessed entirely in the system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Çankaya, 06230, Turkey (Türkiye)

Location

Related Publications (2)

  • Malaithong W, Munjupong S. Combined Continuous Radiofrequency Ablation and Pulsed Neuromodulation to Treat Cervical Facet Joint Pain and Alleviate Postcervical Radiofrequency Side Effects. Anesth Pain Med. 2022 Dec 14;12(6):e129747. doi: 10.5812/aapm-129747. eCollection 2022 Dec.

    PMID: 36938106BACKGROUND
  • Ding Y, Li H, Hong T, Zhu Y, Yao P, Zhou G. Combination of Pulsed Radiofrequency with Continuous Radiofrequency Thermocoagulation at Low Temperature Improves Efficacy and Safety in V2/V3 Primary Trigeminal Neuralgia. Pain Physician. 2018 Sep;21(5):E545-E553.

    PMID: 30282402BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nalan Celebi, Professor

    Hacettepe University

    STUDY DIRECTOR
  • Tuğçe Yavuz, M.D

    Hacettepe University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

July 22, 2024

First Posted

November 19, 2024

Study Start

August 1, 2023

Primary Completion

September 1, 2023

Study Completion

October 1, 2023

Last Updated

November 19, 2024

Record last verified: 2024-07

Locations