Surface Acoustic Wave Ultrasound in Trigeminal Neuralgia Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Manuel Zwecker MD, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01447108
First received: September 15, 2011
Last updated: December 26, 2012
Last verified: December 2012
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Examining the Efficacy of Low Intensity Low Frequency Surface Acoustic Wave Ultrasound(LILF/SAWU) in Trigeminal Neuralgia Pain

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Level of pain [ Time Frame: Change in level of pain from baseline to after two months of treatment ] [ Designated as safety issue: No ]
    Barrow Neurological Index score (BNI ) pain intensity scale will be used

  • Pain intensity and quality of pain [ Time Frame: Change in intensity and quality of pain from baseline to after two months of treatment ] [ Designated as safety issue: No ]
    "SFMPQ" - Short form MCGILL Pain Questionnaire will be used.

  • Functional Health and Wellbeing [ Time Frame: Change in functional health and wellbeing from baseline to after two months of treatment ] [ Designated as safety issue: No ]
    SF-36 Questionnaire will be used


Enrollment: 16
Study Start Date: November 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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™

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01447108

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

Publications:

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
Study First Received: September 15, 2011
Last Updated: December 26, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Sheba Medical Center:
Trigeminal Neuralgia
Tic Douloureux
Low Intensity Low Frequency Surface Acoustic Wave Ultrasound

Additional relevant MeSH terms:
Neuralgia
Tics
Trigeminal Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Dyskinesias
Trigeminal Nerve Diseases
Cranial Nerve Diseases

ClinicalTrials.gov processed this record on April 17, 2014