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Surface Acoustic Wave Ultrasound in Trigeminal Neuralgia Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01447108
Recruitment Status : Completed
First Posted : October 5, 2011
Last Update Posted : December 27, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:

The "Suicide Disease", Trigeminal Neuralgia (TN) is arguably caused by one of the most discrete and eloquently reversible central nervous system lesions known to the field of neurology.

Recently Dr Adahan H. and Dr Binshtok A. have completed an open label series of 25 subjects with refractory TN showing a remarkable positive response rate to TN's treatment with Low Intensity Low Frequency Surface Acoustic Wave Ultrasound (LILF/SAWU).

The primary objective of this study, therefore, is to determine whether this apparent efficacy of Low Intensity Low Frequency Ultrasound (LILFU) in the treatment of TN pain could withstand the rigors of an n=1 crossover placebo control study.

Participants with refractory trigeminal neuralgia pain despite optimized pharmacotherapy for at least six months will be screened for participation in the study based on rigorous inclusion and exclusion criteria. It is judged rather unlikely that such subjects will experience spontaneous regression of their disease in the course of this study.

Patients meeting the inclusion criteria will be treated with four weeks of a placebo Low Intensity Low Frequency Surface Acoustic Wave Ultrasound (LILF/SAWU) device while continuing with their pharmaco-analgesic regimen. All patients will be crossed over to active LILF/SAWU therapy for the next four weeks. Patients will be blinded to all treatments throughout the study. Patients will be instructed to use the device daily overnight, and remove it upon wakening. The device is programmed to work in cycles of 30 minutes on and 30 minutes off, for a total of six- eight hours of intermittent treatment.

At the end of the second month of the study, patients will be offered a choice as to whether they wished to continue with the current (active) device or go back to the 1st (sham) device.

Patient's pain severity will be tracked every two weeks over the course of three months. Functional health and well being will be monitored at intake, post "Placebo" period, post "Active" period and at completion of the study.

Condition or disease Intervention/treatment Phase
Trigeminal Neuralgia Tic Douloureux Device: Low Intensity Low Frequency Surface Acoustic Wave Ultrasound (PainShield™) Phase 4

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Examining the Efficacy of Low Intensity Low Frequency Surface Acoustic Wave Ultrasound(LILF/SAWU) in Trigeminal Neuralgia Pain
Study Start Date : November 2011
Primary Completion Date : November 2012
Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: TN patients
Patients suffering from Trigeminal neuralgia
Device: Low Intensity Low Frequency Surface Acoustic Wave Ultrasound (PainShield™)

All subjects will be treated four weeks with a placebo PainShield™ while continuing with their current pharmaco- analgesic regimen. Aferterwards all subjects will be crossed over to active Painshield™ therapy for the next four weeks.

The Painshield™ device is a patch, which will be applied to their forehead for six-eight hours during night while sleeping.

Other Name: PainShield™

Outcome Measures

Primary Outcome Measures :
  1. Level of pain [ Time Frame: Change in level of pain from baseline to after two months of treatment ]
    Barrow Neurological Index score (BNI ) pain intensity scale will be used

  2. Pain intensity and quality of pain [ Time Frame: Change in intensity and quality of pain from baseline to after two months of treatment ]
    "SFMPQ" - Short form MCGILL Pain Questionnaire will be used.

  3. Functional Health and Wellbeing [ Time Frame: Change in functional health and wellbeing from baseline to after two months of treatment ]
    SF-36 Questionnaire will be used

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged 18 years or above.
  • Diagnosed with trigeminal neuralgia refractory to medical treatment (modified BNI V).

Exclusion Criteria:

  • Male or female, under the age of 18.
  • Active illicit drug use
  • Pregnancy.
  • Psychiatric illness which may prevent the patient from participation in the study.
  • Anesthesia dolorosa with pain greater than or equal to 3/10
  • Dental implants.
  • Other known pathology of the trigeminal nerve including iatrogenic anesthesia dolorosa.
  • Cancer and bone metastases.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01447108

Sheba Medical Center
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Principal Investigator: Manuel Zwecker, MD Sheba Medical Center
More Information

Campbell C. K. Surface Acoustic wave devices for mobile and wireless communications. Chapter-Fundamentals of surface acoustic waves and devices. Academic press NY p20-25.

Responsible Party: Dr. Manuel Zwecker MD, Senour physician at the Department of Neurological Rehabilitation, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01447108     History of Changes
Other Study ID Numbers: SHEBA-8601-11-MZ-CTIL
First Posted: October 5, 2011    Key Record Dates
Last Update Posted: December 27, 2012
Last Verified: December 2012

Keywords provided by Dr. Manuel Zwecker MD, Sheba Medical Center:
Trigeminal Neuralgia
Tic Douloureux
Low Intensity Low Frequency Surface Acoustic Wave Ultrasound

Additional relevant MeSH terms:
Trigeminal Neuralgia
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Trigeminal Nerve Diseases
Facial Neuralgia
Facial Nerve Diseases
Mouth Diseases
Stomatognathic Diseases
Cranial Nerve Diseases