Duloxetine in Patients With Diabetic in Peripheral Neuropathic Pain With or Without Co-morbid Major...
Diabetic NeuropathiesDepressive Disorder1 moreThe primary objective is to evaluate, separately in diabetic polyneuropathic pain (DPNP) patients with and without co-morbid major depressive disorder (MDD), whether duloxetine given as 60 mg to 120 mg once daily (QD) leads to a clinically relevant improvement as measured by the change in Brief Pain Inventory (BPI) 24 hours average interference score from baseline to after 12 weeks. A clinically relevant improvement will be demonstrated if the confidence interval for the mean change from baseline does not lie above the clinically relevant change of -1.35. If statistically significant results are obtained for the DPNP patients with MDD, then the same evaluation will be performed for the DPNP patients without MDD in another confirmatory analysis. As secondary objectives the study will compare the two groups (MDD+/MDD-) regarding efficacy of duloxetine on BPI severity scales, the distribution of different percentages of pain reduction among the patient population, and the patients and physicians impressions of severity and improvement of pain. The study will also compare treatment outcomes regarding patient-relevant functionality and quality of life (QoL) between the two groups (MDD+/MDD-) by evaluating each single BPI interference item, the Short Form 12 (SF-12) Health Questionnaire and the West Haven Multidimensional Pain Inventory (MPI). As a third group of secondary objectives the efficacy of duloxetine of the psychological symptoms (e.g. depression) of DPNP patients with or without depression will be assessed using the Hamilton depression scale, the Beck Depression Inventory-II and the hospital Anxiety and Depression Scale. Further the effect of duloxetine treatment on fasting blood glucose (FBG) and hemoglobin A1c (HbA1c) will be evaluated. To monitor safety and tolerability, treatment discontinuation rates, treatment emergent adverse events, change in vital signs, laboratory results and suicidal thoughts will be assessed.
Efficacy and Safety Study of Lamotrigine to Treat Trigeminal Neuralgia
Trigeminal NeuralgiaThe purpose of this study was to determine the efficacy and safety of lamotrigine in patients with trigeminal neuralgia (TGN).
A 17-Week Trial To Assess Pregabalin For The Treatment Of Nerve Pain Due To Spinal Cord Injury
NeuralgiaSpinal Cord InjuriesThe purpose of this study is to evaluate if pregabalin relieves nerve pain associated with spinal cord injury compared to placebo (pill that contains no active medicine). This study will also evaluate the safety of pregabalin in this patient population.
Clonidine Versus Adenosine to Treat Neuropathic Pain
PainThe purpose of this study is to determine the effects of clonidine and adenosine on nerve pain.
The Use of Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Pain of Predominantly...
Neuropathic PainThe aim of this study is to investigate the effectiveness of TENS in addition to routine care in patients with chronic pain of predominantly neuropathic origin, compared to treatment with routine care alone." Hypothesis: An eventually neuropathic pain component is needed to be identified and alleviated in chronic pain patients to improve the quality of rehabilitation. 0-hypothesis: TENS is not better than than placebo, medication or standard rehabilitation program. A neuropathic pain component does not demand special considerations in rehabilitation of chronic pain patients.
New Topical Treatment for Continued Pain After Shingles
Postherpetic NeuralgiaShingles is an outbreak of rash or blisters on the skin that is caused by the same virus that causes chicken pox. Some people experience continued pain even after the shingles rash and blisters have healed; this pain is known as postherpetic neuralgia. The purpose of this study is to evaluate the effectiveness of a new topical treatment for postherpetic neuralgia in adults.
Treatment of Painful Diabetic Neuropathy With Photon Stimulation
Diabetic NeuropathyPainful3 more1. Objectives: To assess the efficacy of Photon Stimulation compared with placebo, in treating the pain of diabetic neuropathy. To show that Photonic Stimulation for the treatment of painful diabetic neuropathy is cost effective compared to traditional medical interventions. The latter will be explored by an extensive search of the literature and from an equal number of patients being treated in traditional medical practices using traditional medical interventions. At the conclusion of the study the data will be analyzed for cost-benefits and the possibility of crafting a best-practices approach to treat these syndromes that cost billions of dollars a year in health care expenses and lost productivity. 2. Research Design This is a double blinded, randomized, placebo-controlled study of 120 patients with painful diabetic neuropathy. These 120 will be randomly assigned treatments utilizing Photon Therapy, using a defined treatment protocol. We expect that some patients will drop out, and our goal is 100 treated patients, for statistical purposes. The Photon Therapy group will be split into two groups, one group that receives Active Photon Therapy and one group that will be treated with the same type of equipment that has been modified to emit no infrared photons (Non Active Photon Therapy Group ("Placebo")). The patients in the "Non Active Photon Therapy Group" will be offered an Active Photon Treatment Session after completion of the study. The patients in the Photon Therapy Groups will be randomized. There will also be an Historical Control Group of patients, fifty, will have received traditional medical interventions (e.g., narcotics, seizure medications) in traditional medical practices. Data from these individuals will be used to calculate potential cost savings. 3. Methodology: Subjects who meet the inclusion and exclusion criteria and have signed a valid informed consent will be eligible to participate in the study. After screening, subjects in the Photon Therapy groups (both active and nonactive) will undergo four treatment sessions. The first treatment session will vary from the second, third and fourth. During all treatment session, each patient will be imaged with the TIP Infrared Camera before, and after treatment. Infrared imaging can visualize skin temperature changes in a noninvasive manner (2). The first treatment will utilize slightly different protocol than subsequent visits, reduced Photon dosage, 120 instead of 240 joules. Proprioception and protective sensation, characterized by the Semmes-Weinstein monofilament test, and visual and analog pain scoring will also be evaluated before and after each Photon Therapy treatment. 4. Finding: To date, we have just completed 120 patients, using a block randomization scheme not previously reported in this field. We have collected data on nerve function, pain, quality of life, and skin circulation. The data will remain stored until the study is complete to preserve the blinded nature of the project. Data analysis is still incomplete. 4. Clinical Significance Diabetic neuropathy is a chronic and progressive condition that potentially leads to disabling pain, and worse, amputation, for many individuals in the United States each year. Present treatments utilize antiseizure medications, opiate analgesics, and antidepressants, and are inconsistently effective. Development of a new treatment strategy potentially could have significant benefit for a great many patients.
A 2 Week Study of Topical KD7040 in the Treatment of Postherpetic Neuralgia (PHN)
Postherpetic NeuralgiaShingles2 moreThis study will evaluate the safety and efficacy of 2 weeks of topical KD7040 versus placebo in the treatment of postherpetic neuralgia.
Efficacy and Tolerability of Novel A2A Agonist in Treatment of Diabetic Neuropathic Pain
Diabetic Neuropathic PainThe purpose of this study is to evaluate the efficacy and tolerability of BVT.115959 in diabetic patients with neuropathic pain who are either not on analgesia or are on stable analgesia in the month prior to entering the study.
The Efficacy of Motor Cortex Stimulation for Pain Control
Neuropathic PainPhantom Limb Pain5 moreThe objective is to determine if motor cortex stimulation works for the following conditions: Deafferentation facial pain, Upper extremity complex regional pain syndrome (CRPS) and Brachial plexus avulsion or phantom limb pain. Each of these groups of 6 patients (total of 18) will be studied independently and all patients will be implanted with a motor cortex stimulation system. They will be randomised to either a regular or low stimulation setting in the two arms of the study. Each arm will last 3 months.