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

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

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.

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

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

More Information

Publications:

Elias WJ, Burchiel KJ. Microvascular decompression. Clin J Pain. 2002 Jan-Feb;18(1):35-41. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Abdelrady S Ibrahim, MD, Assistant professor of Anesthesia and Intensive care, Assiut University
• ClinicalTrials.gov Identifier: NCT03396406
• Other Study ID Numbers: IRB0000871244
• First Posted: January 11, 2018
• 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:

Trigeminal Neuralgia; Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases