Examining the Efficacy of Low Intensity Low Frequency Surface Acoustic Wave Ultrasound(LILF/SAWU) in Trigeminal Neuralgia Pain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Level of pain
研究概览
简要总结
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.
详细描述
- Introduction:
Trigeminal neuralgia (TN) is one of the most severe and progressive forms of chronic neuropathic pain.
The latest scientific work has shown that the most likely cause of TN is a highly reversible tiny central nervous system (CNS) lesion at the root entry zone (REZ) of the trigeminal nerve measuring less than 0.5 cm cubed.
The presence of a discrete, highly eloquent and highly reversible central nervous system (CNS) lesion presents a unique opportunity to test and measure the neuroegenerative potential of therapeutic modalities that can be effectively delivered to the site of this pathology.
Ultrasound has been shown to be an effective treatment for the demyelination found in carpal tunnel syndrome in man ( Ebenbicher , Resch , Nicolakis, Weisinger ,Uhl, Ghanemm and Fialka 1998) , with numerous research studies showing its ability to accelerate peripheral nerve regeneration and functional recovery in rats(Crisci and Ferreria, 2002). There is also a growing body of scientific evidence demonstrating the efficacy of ultrasound in facilitating wound healing and analgesia. Numerous published research studies of ultrasound, and specifically LILFU, have provided Level 1 evidence of efficacy in bone healing, prevention and treatment of fracture non-union, acceleration of fracture healing, and it is also showing promise in the field of tendon healing. (Campbell C.K and Jorns 2007). In vitro, low-intensity ultrasound, has been shown to have direct non thermal effects on cell physiology, stimulating the expression of numerous genes involved in the healing process, including aggrecan, an insulin-like growth factor, transforming collagen, nitric oxide synthase, cytokines, and angiogenesis (Devor, Amir and Rappaport , 2002).
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •Male or female, under the age of
- •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.
结局指标
主要结局
Level of pain
时间窗: Change in level of pain from baseline to after two months of treatment
Barrow Neurological Index score (BNI ) pain intensity scale will be used
Pain intensity and quality of pain
时间窗: Change in intensity and quality of pain from baseline to after two months of treatment
"SFMPQ" - Short form MCGILL Pain Questionnaire will be used.
Functional Health and Wellbeing
时间窗: Change in functional health and wellbeing from baseline to after two months of treatment
SF-36 Questionnaire will be used
次要结局
未报告次要终点
研究者
Dr. Manuel Zwecker MD
Senour physician at the Department of Neurological Rehabilitation
Sheba Medical Center