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Recurrence of Trigeminal Neuralgia in Patient's Undergoing Radiofrequency Ablation

NCT ID: NCT05101577

Last Updated: 2021-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-01

Study Completion Date

2021-10-20

Brief Summary

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This study aims to find recurrence rate of the trigeminal neuralgia after patients undergo stereotactic rhizotomy by radiofrequency ablation at 80 degrees Celsius for 90 seconds under fluoroscopic guidance, a protocol that was modified from the originally described parameters for rhizotomy by John Tew, Chad J. Morgan and Andresw Grande et al. The presumption being that the higher temperature of the probe tip would lead to a more long-lasting lesion and lesser recurrence, but at the cost of more frequent sensory and motor deficits.

Detailed Description

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Conditions

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Trigeminal Neuralgia, Idiopathic

Keywords

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trigeminal neuralgia stereotactic rhizotomy radiofrequency ablation recurrence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

* 1\. Patients fulfilling ICHD criteria:

Recurrent paroxysms of unilateral facial pain in the distribution(s) of one or more divisions of the trigeminal nerve, with no radiation beyond, and fulfilling criteria B and C

A. Pain has all of the following characteristics:

1. lasting from a fraction of a second to 2 minutes
2. severe intensity
3. electric shock-like, shooting, stabbing or sharp in quality B. Precipitated by innocuous stimuli within the affected trigeminal distribution C. Not better accounted for by another ICHD-3 diagnosis.

2\. Age: Adults of both sexes 3. MRI brain ruled out organic or structural pathologies

Exclusion Criteria

* 1\. Patient with concomitant co-morbid conditions like brain tumours, vascular pathologies or coagulopathies.

2\. Patients who had previously undergone trigeminal ganglion neurolysis with either alcohol or phenol.

3\. Patients who were lost to follow-up before the completion of 6-month period or had not visited back after the procedure 4. Patients on oral anticoagulants 5. Patients declared high risk or ASA 3 and above for general anaesthesia.
Minimum Eligible Age

27 Years

Maximum Eligible Age

91 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shifa Clinical Research Center

OTHER

Sponsor Role lead

Responsible Party

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Muhammad Hasan Wasim

Fellow Pain Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Salman A. Saleem, MBBS;FCPS

Role: STUDY_DIRECTOR

Shifa Clinical Research Center

References

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Taha JM, Tew JM Jr, Buncher CR. A prospective 15-year follow up of 154 consecutive patients with trigeminal neuralgia treated by percutaneous stereotactic radiofrequency thermal rhizotomy. J Neurosurg. 1995 Dec;83(6):989-93. doi: 10.3171/jns.1995.83.6.0989.

Reference Type BACKGROUND
PMID: 7490643 (View on PubMed)

Rashid A, Pintea B, Kinfe TM, Surber G, Hamm K, Bostrom JP. LINAC stereotactic radiosurgery for trigeminal neuralgia -retrospective two-institutional examination of treatment outcomes. Radiat Oncol. 2018 Aug 22;13(1):153. doi: 10.1186/s13014-018-1102-2.

Reference Type BACKGROUND
PMID: 30134992 (View on PubMed)

Kao CH, Lee MH, Yang JT, Tsai YH, Lin MH. Percutaneous Radiofrequency Rhizotomy Is Equally Effective for Trigeminal Neuralgia Patients with or Without Neurovascular Compression. Pain Med. 2022 Apr 8;23(4):807-814. doi: 10.1093/pm/pnab221.

Reference Type BACKGROUND
PMID: 34264315 (View on PubMed)

Zhao G, Sun X, Zhang Z, Yang H, Zheng X, Feng B. Clinical efficacy of MVD combined with PSR in the treatment of primary trigeminal neuralgia. Exp Ther Med. 2020 Aug;20(2):1582-1588. doi: 10.3892/etm.2020.8871. Epub 2020 Jun 10.

Reference Type BACKGROUND
PMID: 32742390 (View on PubMed)

Elnashar A, Patel SK, Kurbanov A, Zvereva K, Keller JT, Grande AW. Comprehensive anatomy of the foramen ovale critical to percutaneous stereotactic radiofrequency rhizotomy: cadaveric study of dry skulls. J Neurosurg. 2019 Apr 19;132(5):1414-1422. doi: 10.3171/2019.1.JNS18899. Print 2020 May 1.

Reference Type BACKGROUND
PMID: 31003215 (View on PubMed)

Other Identifiers

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ShifaCRC

Identifier Type: -

Identifier Source: org_study_id