Comparison Between Radiofrequency and Balloon Compression in the Treatment of Idiopathic Trigeminal Neuralgia

University of Sao Paulo

Status: Terminated

Conditions: Trigeminal Neuralgia

Treatments: Procedure: Radiofrequency Thermal Coagulation Rhizotomy; Procedure: Balloon Compression Rhizotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02427074

1180/09

Details and patient eligibility

About

Two percutaneous procedures used in the treatment of idiopathic trigeminal neuralgia are analysed. The effects on pain relief, alterations in cutaneous sensibility and olfactory and salivatory functions are analysed as well.

Full description

Patients diagnosed with idiopathic trigeminal neuralgia, refractory or intolerant to medical treatment, are randomly assigned (after signing a consent form), to receive one of two percutaneous procedures. The patients are evaluated a week before and a week, a month, two months, three months and six months after the surgery.

The questionnaires (Short-Form of the McGill Pain Questionnaire - SF-MPQ, Douleur Neuropathique - DN4, Neuropathic Pain Symptom Inventory - NPSI, Brief Pain Inventory - BPI, Global Clinical Impression - GCI, Hospital Anxiety and Depression - HAD, Brief World Health Organization Quality of Life Questionnaire - WHOQOL-brief, Pain Catastrophizing Scale - PCS) and tests (Quantitative Sensory Testing - QST, olfactory threshold - OT - and discrimination - OD, taste threshold - TT, and salivatory quantification - SQ) are applied as follows:

• Pre-op evaluation: SF-MPQ, DN4, BPI, NPSI, HAD, WHOQOL-brief, PCS, QST, OT, OD, TT, SQ.
• First visit post-op: SF-MPQ, BPI, NPSI, GCI
• Second visit post-op: SF-MPQ, BPI, NPSI, GCI
• Third visit post-op: SF-MPQ, BPI, NPSI, GCI
• Fourth visit post-op: SF-MPQ, DN4, BPI, NPSI, GCI, WHOQOL-brief, HAD, PCS, QST, OT, TT, SQ.
• Fifth visit post-op: SF-MPQ, DN4, BPI, NPSI, GCI, WHOQOL-brief, HAD, PCS, QST, OT, OD, TT, SQ.

Patients with pain recurrence are excluded after the last visit attended. An exploratory analysis is made with 30 patients for a proper sample size calculation during the study.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Idiopathic Trigeminal Neuralgia
• Refractory/Intolerable medical treatment
• Pain restricted to second or third trigeminal division

Exclusion criteria

• Secondary Trigeminal Neuralgia
• Pain restricted to the first trigeminal division
• Refuse to participate
• Unable to comprehend the questionnaires

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

33 participants in 2 patient groups

Balloon Compression Rhizotomy

Active Comparator group

Description:

Patients that are submitted to Balloon Compression Rhizotomy

Treatment:

Procedure: Balloon Compression Rhizotomy

Radiofrequency Thermal Coagulation Rhizotomy

Active Comparator group

Description:

Patients that are submitted to Radiofrequency Thermal Coagulation Rhizotomy

Treatment:

Procedure: Radiofrequency Thermal Coagulation Rhizotomy