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Guideline Summary
Guideline Title
Stereotactic radiosurgery for patients with intractable typical trigeminal neuralgia who have failed medical management.
Bibliographic Source(s)
IRSA. Stereotactic radiosurgery for patients with intractable typical trigeminal neuralgia who have failed medical management. Harrisburg (PA): IRSA; 2009 Jan. 11 p. (Radiosurgery practice guideline report; no. 1-03).  [68 references]
Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: 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]

Scope

Disease/Condition(s)

Trigeminal neuralgia, typical (tic douloureux)

Guideline Category
Evaluation
Management
Treatment
Clinical Specialty
Neurological Surgery
Neurology
Radiation Oncology
Intended Users
Dentists
Health Care Providers
Hospitals
Managed Care Organizations
Nurses
Physicians
Utilization Management
Guideline Objective(s)
  • To develop an evidence and consensus-based stereotactic radiosurgery practice guideline to be used by medical and public health professionals to make radiosurgery treatment recommendations for patients with intractable trigeminal neuralgia who have failed (refractory to or intolerant of) medical management
  • To improve outcomes for typical trigeminal neuralgia patients by assisting physicians and clinicians in applying research evidence to clinical decisions while promoting the responsible use of health care resources
Target Population

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

Interventions and Practices Considered
  1. Stereotactic radiosurgery dosing schedules:
    • 75 Gy (single fraction to the trigeminal nerve)
    • 80 Gy (single fraction to the trigeminal nerve)
    • 90 Gy (single fraction to the trigeminal nerve)
  2. Follow-up
    • Assess pain relief (3, 6, 12 months)
    • Taper off medications if patient remains pain free
  3. Recurrent trigeminal neuralgia
    • Repeat radiosurgery (50–70 Gy in a single fraction to the trigeminal nerve)
Major Outcomes Considered
  • Pain control
  • Quality of life (adverse effects of radiosurgery)
  • Neurological outcome
  • Use of pain medications

Methodology

Methods Used to Collect/Select the Evidence
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

MEDLINE and PUBMED searches were completed for the years 1966 to January 2009. Search terms included: tic douloureux, trigeminal neuralgia, stereotactic radiosurgery, Gamma Knife®, CyberKnife®, irradiation, clinical trials, research design, practice guidelines, and meta-analysis. Bibliographies from recent published reviews were reviewed and relevant articles were retrieved.

Number of Source Documents

68

Methods Used to Assess the Quality and Strength of the Evidence
Expert Consensus (Committee)
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence

This classification is based on the Bandolier system (http://www.medicine.ox.ac.uk/bandolier/band6/b6-5.html External Web Site Policy) adapted for a systematic review.

Type & Strength of Evidence in Medical Literature

Type I: Evidence from a systematic review (which includes at least one randomized controlled trial and a summary of all included studies).

Type II: Evidence from a well designed randomized controlled trial of appropriate size.

Type III: Evidence from a well designed intervention study without randomization. A common research design is the before-and-after study.

Type IV: Evidence from a well designed non-experimental study, e.g., cohort, case-control or cross-sectional studies. (Also includes studies using purely qualitative methods. Economic analyses [cost-effectiveness studies] are also classified as Type IV evidence.)

Type V: Opinions of respected authorities, based on clinical evidence, descriptive studies or reports of expert consensus committees.

Methods Used to Analyze the Evidence
Systematic Review with Evidence Tables
Description of the Methods Used to Analyze the Evidence

The literature identified was reviewed and opinions were sought from experts in the diagnosis and management of trigeminal neuralgia, including members of the working group.

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

The working group included physicians and staff of major medical centers that provide radiosurgery.

The initial draft of the consensus statement was a synthesis of research information obtained in the evidence gathering process. Members of the working group provided formal written comments that were incorporated into the preliminary draft of the statement. No significant disagreements existed. 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 listed in the original guideline document.

Rating Scheme for the Strength of the Recommendations

Not applicable

Cost Analysis

Guideline developers reviewed published cost analyses.

Method of Guideline Validation
External Peer Review
Internal Peer Review
Description of Method of Guideline Validation

The recommendations were mailed to all committee members. Feedback was obtained through this e-mail survey consisting of proposed guidelines asking for comments on the guidelines and whether the recommendation should serve as a practice guideline.

This practice guideline is an updated original guideline approved by the International RadioSurgery Association (IRSA) Board of Directors and issued in January 2009.

Recommendations

Major Recommendations
  • Brain Stereotactic Radiosurgery (SRS) involves the use of precisely directed, closed skull, single fraction (one session) of radiation to create a desired radiobiologic response within the brain with minimal effects to surrounding structures or tissues. In the case of trigeminal neuralgia a relatively high dose of focused radiation is delivered precisely to the trigeminal nerve under the direct supervision of a radiosurgery team. In Centers of Excellence, the radiosurgery team is composed of a neurosurgeon, radiation oncologist, physicist and registered nurse.
  • Patients with typical trigeminal neuralgia who have had an adequate trial of medications can be offered stereotactic radiosurgery. 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 months and six months, then at 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 trigeminal 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. Current data suggest that CyberKnife® stereotactic radiosurgery for trigeminal neuralgia has an increased risk of sensory dysfunction and other neurological complications (see Table 1 in the original guideline document).
Clinical Algorithm(s)

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

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

Type 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.

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Studies show a significant decrease in pain (decreased severity and reduced need to take medications).

Subgroup(s) Most Likely to Benefit

Patients with typical trigeminal neuralgia (intermittent lancinating pain typically relieved by carbamazepine) without prior surgical procedure

Potential Harms
  • The main complications after radiosurgery are new facial sensory symptoms caused by partial trigeminal nerve injury.
  • Current data suggest that CyberKnife® stereotactic radiosurgery for trigeminal neuralgia has an increased risk of sensory dysfunction and other neurological complications (see Table 1 in the original guideline document).

Major adverse effects of trigeminal neuralgia radiosurgery occur very infrequently with Gamma Knife® technology:

  • Facial numbness <10%
  • Neuropathic pain <1%
  • Motor weakness <1%

Subgroup(s) Likely to Be Harmed

Patients with:

  • Atypical facial pain (non-paroxysmal pain)
  • Deafferentation facial pain
  • Temporomandibular joint (TMJ) related facial pain
  • Orofacial pain

Qualifying Statements

Qualifying Statements
  • 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 situations. Further, the International RadioSurgery Association (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.
  • This guideline is intended to provide the scientific foundation and initial framework for patients who have been diagnosed with trigeminal neuralgia. The assessment and recommendations provided herein represent the best professional judgment of the working group at this time, based on clinical research data and expertise currently available. The conclusions and recommendations will be regularly reassessed as new information becomes available.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Implementation Tools
Clinical Algorithm
Patient Resources
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Getting Better
Living with Illness
IOM Domain
Effectiveness

Identifying Information and Availability

Bibliographic Source(s)
IRSA. Stereotactic radiosurgery for patients with intractable typical trigeminal neuralgia who have failed medical management. Harrisburg (PA): IRSA; 2009 Jan. 11 p. (Radiosurgery practice guideline report; no. 1-03).  [68 references]
Adaptation

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

Date Released
2003 Sep (revised 2009 Jan)
Guideline Developer(s)
IRSA - Professional Association
Source(s) of Funding

IRSA (International RadioSurgery Association)

Guideline Committee

The IRSA Medical Advisory Board Guidelines Committee and representatives in the industry.

Composition of Group That Authored the Guideline

The radiosurgery guidelines group is comprised of neurosurgeons and radiation oncologists. Community representatives did not participate in the development of this guideline.

Committee members: L. Dade Lunsford, M.D., Neurosurgeon, Chair; Ajay Niranjan, M.B.B.S., M.Ch., Neurosurgeon; Ron Young, M.D., Neurosurgeon; Ronald Brisman, M.D., Neurosurgeon; David Cunningham, M.D., Neurosurgeon; Christer Lindquist, M.D., Neurosurgeon; David Newell, M.D., Neurosurgeon; John C. Flickinger, M.D., Radiation Oncologist; Tonya K. Ledbetter, M.S., M.F.S, Editor; Rebecca L. Emerick, M.S., M.B.A., C.P.A., ex officio

Financial Disclosures/Conflicts of Interest

The International RadioSurgery Association (IRSA) makes every effort to avoid any actual or potential conflicts of interest that may arise as a result of a personal, professional, or business interest of a member of the radiosurgery guidelines group.

Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: 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]

Guideline Availability

Electronic copies: Available in Portable Document Format (PDF) from the IRSA Web site External Web Site Policy.

Print copies: Available from the IRSA, P.O. Box 5186, Harrisburg, PA 17110.

Availability of Companion Documents

None available

Patient Resources

The following is available:

  • Trigeminal neuralgia. Brain Talk 2003;8(1):1-12. Electronic copies: Available in Portable Document Format (PDF) from the IRSA Web site External Web Site Policy.

Print copies: Available from the IRSA, P.O. Box 5186, Harrisburg, PA 17110.

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC Status

This NGC summary was completed by ECRI on March 8, 2004. The information was verified by the guideline developer on April 7, 2004. This NGC summary was updated by ECRI Institute on August 11, 2009. The updated information was verified by the guideline developer on August 31, 2009.

Copyright Statement

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.

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