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

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ClinicalTrials.gov Identifier: NCT03396406
Recruitment Status : Completed
First Posted : January 11, 2018
Last Update Posted : January 11, 2018
Sponsor:
Information provided by (Responsible Party):
Abdelrady S Ibrahim, MD, Assiut University

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.

Condition or disease Intervention/treatment Phase
Trigeminal Neuralgia Device: Pulsed radiofrequency (PRF) Device: thermocoagulation Not Applicable

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:-

  1. 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
  2. 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Extended Duration Pulsed Radiofrequency Plus Low Temperature Thermal Radiofrequency With Thermal Radiofrequency Alone in Treatment of Recurrent Trigeminal Neuralgia
Actual Study Start Date : August 2012
Actual Primary Completion Date : June 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PCRF group
received Pulsed radiofrequency (PRF) at 42°C for 8 minutes followed by CRF at 60°C for 270s
Device: Pulsed radiofrequency (PRF)
received PRF at 42°C for 8 minutes followed by CRF at 60°C for 270s

Experimental: CRF group
received sole thermocoagulation at 70°C for 270 s
Device: thermocoagulation
received sole CRF at 70°C for 270 s




Primary Outcome Measures :
  1. Visual analog pain score [ Time Frame: one month ]
    The response for interventional treatment was evaluated in subsequent visits at pain clinic or by telephone

  2. Visual analog pain score [ Time Frame: 6 months ]
    The response for interventional treatment was evaluated in subsequent visits at pain clinic or by telephone

  3. Visual analog pain score [ Time Frame: one year ]
    The response for interventional treatment was evaluated in subsequent visits at pain clinic or by telephone

  4. Visual analog pain score [ Time Frame: 2 years ]
    The response for interventional treatment was evaluated in subsequent visits at pain clinic or by telephone


Secondary Outcome Measures :
  1. change in medical treatment [ Time Frame: 2 years ]
    need for tricyclic antidepressant



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03396406


Locations
Egypt
Assiut university faculty of medicine
Assiut, Egypt, 7111
Sponsors and Collaborators
Assiut University
Investigators
Principal Investigator: Abdelrady S Ibrahim, M.D. Assiut university faculty of medicine

Publications:
Responsible Party: Abdelrady S Ibrahim, MD, Assistant professor of Anesthesia and Intensive care, Assiut University
ClinicalTrials.gov Identifier: NCT03396406     History of Changes
Other Study ID Numbers: IRB0000871244
First Posted: January 11, 2018    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Abdelrady S Ibrahim, MD, Assiut University:
trigeminal neuralgia, radiofrequency

Additional relevant MeSH terms:
Neuralgia
Trigeminal Neuralgia
Trigeminal Nerve Diseases
Facial Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Facial Nerve Diseases
Mouth Diseases
Stomatognathic Diseases
Cranial Nerve Diseases