• IRSA. Stereotactic radiosurgery for patients with intractable typical trigeminal neuralgia who have failed medical management. Harrisburg (PA): IRSA; 2003 Sep. 10 p. (Radiosurgery practice guideline report; no. 1-03). [43 references]

This is the current release of the guideline.

Trigeminal neuralgia, typical (tic douloureux)

Evaluation
Management
Treatment

Neurological Surgery
Neurology
Radiation Oncology

Health Care Providers
Hospitals
Managed Care Organizations
Nurses
Physicians
Utilization Management

To develop an evidenced and consensus-based stereotactic radiosurgery practice guideline for trigeminal neuralgia treatment recommendations to be used by medical and public health professionals following the diagnosis of trigeminal neuralgia

Men and women with intractable (medically refractory) typical trigeminal neuralgia, often those with concomitant medical co-morbidity or advanced age

1. Stereotactic radiosurgery dosing schedules:
   • 75 Gy (single fraction to the trigeminal nerve)
   • 80 Gy (central dose targeted to the trigeminal nerve a few millimeters proximal to its entry into the brain stem)
   • 90 Gy (central dose to the trigeminal nerve near the trigeminal ganglion)
2. Follow-up
   • Assess pain relief (3, 6, 12 months)
   • Taper off medications if patient remains pain free
3. Recurrent trigeminal neuralgia
   • Repeat radiosurgery (50 – 60 Gy)

• Pain control
• Quality of life
• Neurological outcome

Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases

MEDLINE and PUBMED searches were completed for the years 1966 to September 2003. Search terms included: tic douloureux, trigeminal neuralgia, stereotactic radiosurgery, Gamma Knife®, irradiation, clinical trials, linear accelerator, research design, practice guidelines, and meta-analysis. Bibliographies from recent published reviews were reviewed and relevant articles were retrieved.

43

Expert Consensus (Committee)
Weighting According to a Rating Scheme (Scheme Given)

Review of Published Meta-Analyses
Systematic Review with Evidence Tables

Not stated

Expert Consensus

The recommendations were a synthesis of research obtained in the evidence gathering process by a core group of two members. The recommendations were mailed to all committee members and feedback was obtained through a survey asking for comments and whether the recommendation should serve as a practice guideline. No significant disagreements existed.

Not applicable

A formal cost analysis was not performed and published cost analyses were not reviewed.

External Peer Review
Internal Peer Review

The final statement incorporates all relevant evidence obtained by the literature search in conjunction with the final consensus recommendations supported by all working group members. The guideline was approved by the IRSA (International RadioSurgery Association) Board of Directors and issued in September 2003.

• Stereotactic radiosurgery is defined as a relatively high dose of focused radiation delivered precisely to the trigeminal root nerve, under the direct supervision of a medical team (neurosurgeon, radiation oncologist, registered nurse, and medical physicist), in one surgical session.
• Patients with typical trigeminal neuralgia who have had an adequate trial of medications can be offered stereotactic radiosurgery. Stereotactic radiosurgery is typically used in patients with medical co-morbidities or pain refractory to prior surgical procedures, patients at risk for side effects from percutaneous ablative procedures, and those in more advanced age groups.
• The optimal dose range for trigeminal neuralgia has been established. A commonly used dose range of 75 to 90 Gy in a single fraction to the trigeminal nerve is suggested, using a 4-mm collimator radiation field. Most centers prefer 80 Gy as a central dose targeted to the trigeminal nerve a few millimeters proximal to its entry into the brain stem; however, 90 Gy as a central dose to the trigeminal nerve near the trigeminal ganglion has also been used routinely in some centers.
• Patients who have failed other surgical procedures for trigeminal neuralgia should also receive 75 to 90 Gy to the trigeminal nerve. A safe interval between the initial surgery and stereotactic radiosurgery is unknown, but it is reasonable to perform radiosurgery if there is no improvement or pain recurs following the initial surgical procedures.
• After radiosurgery, patients are followed to assess pain relief at three-month, six-month and yearly intervals. Their pre-radiosurgery pain medications are continued at the same doses until pain relief is obtained. Medications can be gradually tapered off if the patient remains pain free.
• Patients who have recurrence of pain following trigeminal neuralgia radiosurgery or who had a partial initial response can undergo a second stereotactic radiosurgery using 50 to 70 Gy to the trigerminal nerve (depending on the elapsed time between treatments). A generally safe interval between first and second radiosurgeries is six months.
• At present, technology to deliver focal small-volume fields is limited to Gamma Knife® by the strength of published data. Early data from dedicated modified linear accelerator centers with documented ability to deliver beams <5 mm are under evaluation.

The original guideline contains a clinical algorithm for "Trigeminal Neuralgia Management."

Type I, II, and III evidence exists in support of stereotactic radiosurgery for intractable trigeminal neuralgia. Refer to the "Rating Scheme for the Strength of the Evidence" field.

• Studies show a significant decrease in pain (decreased severity and reduced need to take medications). Complete pain relief (excellent or good) was maintained in 63.6 + 3.3% of patients at one year and in 56.6 + 3.8% at three years. Greater than 50% pain relief was maintained in 75.8 + 2.9% of patients at one year and in 67.2 + 3.9% at three years.
• Literature has documented the cost savings benefit of stereotactic radiosurgery versus invasive surgical procedures and the lower risk potential of bleeding, anesthesia problems, infections, and side effects which may be transient or permanent disabilities from open surgery.

The main complications after radiosurgery are new facial sensory symptoms caused by partial trigeminal nerve injury. Seventeen patients (7.7%) in one series developed increased facial paresthesia and/or facial numbness that lasted longer than six months. One patient (0.4%) developed deafferentation pain. Increased risk of trigeminal nerve dysfunction has been reported with the use of high-dose (90 Gy) radiosurgery.

Patients with well controlled trigeminal neuralgia through medical management

This guideline is not intended as a substitute for professional medical advice and does not address specific treatments or conditions for any patient. Those consulting this guideline are to seek qualified consultation utilizing information specific to their medical situation. Further, the IRSA does not warrant any instrument or equipment nor make any representations concerning its fitness for use in any particular instance nor any other warranties whatsoever.

An implementation strategy was not provided.

Getting Better
Living with Illness

Effectiveness
Patient-centeredness

• IRSA. Stereotactic radiosurgery for patients with intractable typical trigeminal neuralgia who have failed medical management. Harrisburg (PA): IRSA; 2003 Sep. 10 p. (Radiosurgery practice guideline report; no. 1-03). [43 references]

Not applicable: The guideline was not adapted from another source.

2003 Sep

IRSA - Professional Association

IRSA is a non-profit entity dedicated to promoting the development of scientifically relevant practice guidelines for stereotactic radiosurgery. IRSA works to educate and provide support for physicians, hospitals, insurers, and patients.

IRSA

IRSA Physician Advisory Board Guidelines Committee

Committee members: Dr. L. Dade Lunsford, MD, Neurosurgeon (Chair); Ajay Niranjan, MBBS, MCh, Neurosurgeon; Ron Young, MD, Neurosurgeon; Ronald Brisman, MD, Neurosurgeon; David Cunningham, MD, Neurosurgeon; Christer Lindquist, MD, Neurosurgeon (European Co-Chair); David Newell, MD, Neurosurgeon; John C. Flickinger, MD, Radiation Oncologist; Ann Maitz, MS, Medical Physicist; Tonya K. Ledbetter, MS, MFS, Editor; Rebecca L. Emerick, MS, MBA, CPA, ex officio

Not stated

This is the current release of the guideline.

None available

This NGC summary was completed by ECRI on March 8, 2004. The information was verified by the guideline developer on April 7, 2004.

This guideline is copyrighted by IRSA and may not be reproduced without the written permission of IRSA. IRSA reserves the right to revoke copyright authorization at any time without reason.