NCT03396406

Brief Summary

Forty patients with history of recurrent TN were recruited in Assiut University Hospitals, Pain Unit from 2012 to 2017. Before the study, all patients were given adequate and informative data about the nature of the study, interventional procedure and its possible complications, and a well-informed written consent was obtained from each patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable

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, 2012

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 11, 2018

Completed
Last Updated

January 11, 2018

Status Verified

January 1, 2018

Enrollment Period

4.8 years

First QC Date

January 4, 2018

Last Update Submit

January 9, 2018

Conditions

Trigeminal Neuralgia

Keywords

trigeminal neuralgia, radiofrequency

Outcome Measures

Primary Outcomes (4)

  • Visual analog pain score

    The response for interventional treatment was evaluated in subsequent visits at pain clinic or by telephone

    one month

  • Visual analog pain score

    The response for interventional treatment was evaluated in subsequent visits at pain clinic or by telephone

    6 months

  • Visual analog pain score

    The response for interventional treatment was evaluated in subsequent visits at pain clinic or by telephone

    one year

  • Visual analog pain score

    The response for interventional treatment was evaluated in subsequent visits at pain clinic or by telephone

    2 years

Secondary Outcomes (1)

  • change in medical treatment

    2 years

Study Arms (2)

PCRF group

EXPERIMENTAL

received Pulsed radiofrequency (PRF) at 42°C for 8 minutes followed by CRF at 60°C for 270s

Device: Pulsed radiofrequency (PRF)

CRF group

EXPERIMENTAL

received sole thermocoagulation at 70°C for 270 s

Device: thermocoagulation

Interventions

Pulsed radiofrequency (PRF)DEVICE

received PRF at 42°C for 8 minutes followed by CRF at 60°C for 270s

PCRF group
thermocoagulationDEVICE

received sole CRF at 70°C for 270 s

CRF group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with severe, recurrent TN for more than 6 months, non-satisfactory pain relief with medical treatment or/and intolerable to medical drugs
  • Age more than 18 years old
  • Pain score ≥ 7
  • Patient consent to participate

You may not qualify if:

  • Known concurrent neurological or neurodegenerative diseases such as multiple sclerosis, and myasthenia gravis
  • Breast feeding or pregnant women
  • Advanced malignancy or brain stem tumors
  • Coagulopathy or patients on anticoagulant medications
  • Allergy/ sensitivity to Lidocaine anesthetic or/and non- ionic contrast media
  • Presence of Progressive Motor or sensory deficit in the distribution of trigeminal nerve
  • Active psychological or mental diseases
  • Uncontrolled medical or respiratory conditions
  • Patients who are unwilling to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university faculty of medicine

Asyut, 7111, Egypt

Location

Related Publications (2)

  • Elias WJ, Burchiel KJ. Microvascular decompression. Clin J Pain. 2002 Jan-Feb;18(1):35-41. doi: 10.1097/00002508-200201000-00006.

    PMID: 11803301BACKGROUND

  • Abdel-Rahman KA, Elawamy AM, Mostafa MF, Hasan WS, Herdan R, Osman NM, Ibrahim AS, Aly MG, Ali AS, Abodahab GM. Combined pulsed and thermal radiofrequency versus thermal radiofrequency alone in the treatment of recurrent trigeminal neuralgia after microvascular decompression: A double blinded comparative study. Eur J Pain. 2020 Feb;24(2):338-345. doi: 10.1002/ejp.1489. Epub 2019 Oct 16.

    PMID: 31571339DERIVED

MeSH Terms

Conditions

Trigeminal Neuralgia

Interventions

Pulsed Radiofrequency TreatmentElectrocoagulation

Condition Hierarchy (Ancestors)

Trigeminal Nerve DiseasesFacial NeuralgiaFacial Nerve DiseasesMouth DiseasesStomatognathic DiseasesCranial Nerve DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRadiofrequency TherapyRehabilitationCauteryAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Abdelrady S Ibrahim, M.D.

    Assiut university faculty of medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Anesthesia and Intensive care

Study Record Dates

First Submitted

January 4, 2018

First Posted

January 11, 2018

Study Start

August 1, 2012

Primary Completion

June 1, 2017

Study Completion

September 1, 2017

Last Updated

January 11, 2018

Record last verified: 2018-01

Locations

EG(1)