Recurrence of Trigeminal Neuralgia in Patient's Undergoing Radiofrequency Ablation

NCT05101577 | Completed

• 1 other identifier: ShifaCRC
• Study Type: observational
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Trigeminal Neuralgia, Idiopathic

Keywords

trigeminal neuralgia; stereotactic rhizotomy; radiofrequency ablation; recurrence

Outcome Measures

Primary Outcomes (2)

• Recurrence rate of trigeminal neuralgia after stereotactic rhizotomy

  Recurrence of pain in the same distribution of the trigeminal nerve branch or branches for which the stereotactic rhizotomy was originally performed

  Recurrence within 12 months of the intervention

• Proportion of patients with neurological deficits after stereotactic rhizotomy

  locally deviced protocol for stereotactic rhizotomy of the involved trigeminal gangion dictates the use of higher temperature of 80 degree Celsius for 90 seconds, which translates into better pain relief and longer pain free intervals at the cost of higher percentage of sensory and motor deficits

  5 years

Eligibility Criteria

• Age: 27 Years - 91 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients of all genders presenting to Pain Clinic, referred of otherwise, diagnosed to have trigeminal neuralgia without concomitant central nervous pathologies including space occupying lesions, vascular and auto-immune disorders, who were planned for stereotactic rhizotomy under deep sedation and monitored anesthesia care as daycare cases.

You may qualify if:

• \. 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:
• lasting from a fraction of a second to 2 minutes
• severe intensity
• 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.
• \. Age: Adults of both sexes 3. MRI brain ruled out organic or structural pathologies

You may not qualify if:

• \. Patient with concomitant co-morbid conditions like brain tumours, vascular pathologies or coagulopathies.
• \. Patients who had previously undergone trigeminal ganglion neurolysis with either alcohol or phenol.
• \. 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.

Sponsors & Collaborators

• Shifa Clinical Research Center: lead

Related Publications (5)

• 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.

  PMID: 7490643 BACKGROUND

• 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.

  PMID: 30134992 BACKGROUND

• 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.

  PMID: 34264315 BACKGROUND

• 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.

  PMID: 32742390 BACKGROUND

• 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.

  PMID: 31003215 BACKGROUND

MeSH Terms

Conditions

Trigeminal Neuralgia; Recurrence

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Salman A. Saleem, MBBS;FCPS

  Shifa Clinical Research Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow Pain Medicine

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: November 1, 2021
• Study Start: September 1, 2016
• Primary Completion: August 31, 2021
• Study Completion: October 20, 2021
• Last Updated: November 1, 2021

Record last verified: 2021-10