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Treatment of Recurrent Trigeminal Neuralgia by Using Extended Duration of Pulsed Radiofrequency

Primary Purpose

Trigeminal Neuralgia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Pulsed radiofrequency (PRF)
thermocoagulation
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigeminal Neuralgia focused on measuring trigeminal neuralgia, radiofrequency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • 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

Exclusion Criteria:

  • • 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

Sites / Locations

  • Assiut university faculty of medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PCRF group

CRF group

Arm Description

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

received sole thermocoagulation at 70°C for 270 s

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

change in medical treatment
need for tricyclic antidepressant

Full Information

First Posted
January 4, 2018
Last Updated
January 9, 2018
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03396406
Brief Title
Treatment of Recurrent Trigeminal Neuralgia by Using Extended Duration of Pulsed Radiofrequency
Official Title
Comparison of Extended Duration Pulsed Radiofrequency Plus Low Temperature Thermal Radiofrequency With Thermal Radiofrequency Alone in Treatment of Recurrent Trigeminal Neuralgia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 2012 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
All interventions were done in a specialized well-equipped unit at Assiut University hospital and continuous hemodynamic monitoring with pulse oximetry, blood pressure and ECG applied for each patient. Light sedation by using midazolam 5mg bolus. In a supine position with slightly extended head and under fluoroscopic control, C arm rotated caudo-cranially and ipsilateraly to produce an oblique submental view and visualize foramen ovale beside the ramus of the mandible. The point of entry varied according to the affected branch, but it ranged from 0.5-1.5 cm from the corner of the mouth. The point of entry cleaned by aseptic solution and anaesthetized with 1% of Lidocaine. C arm has been rotated laterally to confirm the depth of penetration once the needle entered into Meckel's cavity. RF electrode (22-G, 10 cm needle, with a curved 5 mm active tip, Neurotherm 1100) was used and the exact position of the needle confirmed by sensory stimulation, motor stimulation and negative aspiration as the following criteria:- Sensory stimulation (50 Hz) threshold between 0.1-0.3 V which made paresthesia and/ or tingling in the affected painful area. Patient was awake to respond to the sensory stimulation Motor stimulation at 2Hz with 0.1-1.5V caused muscle contraction of the lower mandible. After confirming the position of the RF electrode, each patient received 0.5 ml of 1% of Lidocaine to avoid discomfort during treatment. Then the type of intervention determined by the person who was responsible for randomisation process and who did not involve in assessing eligibility or interventional technique and divided into:- Group A: pulsed radiofrequency was applied for 4 cycles of 120 seconds ( 8 minutes in total) at 45 V and temperature was set at 42 C. then conventional radiofrequency thermal lesion was applied for 3 cycles of 90 seconds at 60 c. Group B: thermal energy was applied gradually for 3 cycles of 90 seconds at 70 C.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigeminal Neuralgia
Keywords
trigeminal neuralgia, radiofrequency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PCRF group
Arm Type
Experimental
Arm Description
received Pulsed radiofrequency (PRF) at 42°C for 8 minutes followed by CRF at 60°C for 270s
Arm Title
CRF group
Arm Type
Experimental
Arm Description
received sole thermocoagulation at 70°C for 270 s
Intervention Type
Device
Intervention Name(s)
Pulsed radiofrequency (PRF)
Intervention Description
received PRF at 42°C for 8 minutes followed by CRF at 60°C for 270s
Intervention Type
Device
Intervention Name(s)
thermocoagulation
Intervention Description
received sole CRF at 70°C for 270 s
Primary Outcome Measure Information:
Title
Visual analog pain score
Description
The response for interventional treatment was evaluated in subsequent visits at pain clinic or by telephone
Time Frame
one month
Title
Visual analog pain score
Description
The response for interventional treatment was evaluated in subsequent visits at pain clinic or by telephone
Time Frame
6 months
Title
Visual analog pain score
Description
The response for interventional treatment was evaluated in subsequent visits at pain clinic or by telephone
Time Frame
one year
Title
Visual analog pain score
Description
The response for interventional treatment was evaluated in subsequent visits at pain clinic or by telephone
Time Frame
2 years
Secondary Outcome Measure Information:
Title
change in medical treatment
Description
need for tricyclic antidepressant
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • 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 Exclusion Criteria: • 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdelrady S Ibrahim, M.D.
Organizational Affiliation
Assiut university faculty of medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut university faculty of medicine
City
Assiut
ZIP/Postal Code
7111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
11803301
Citation
Elias WJ, Burchiel KJ. Microvascular decompression. Clin J Pain. 2002 Jan-Feb;18(1):35-41. doi: 10.1097/00002508-200201000-00006.
Results Reference
background
PubMed Identifier
31571339
Citation
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.
Results Reference
derived

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Treatment of Recurrent Trigeminal Neuralgia by Using Extended Duration of Pulsed Radiofrequency

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