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A Symptom Management Efficacy Study to Reduce Distal Neuropathic Pain

减轻远端神经病理性疼痛的症状管理功效研究

基本信息

批准号：
10405461
负责人：
JOYCE K ANASTASI
金额：
$ 66.47万
依托单位：
NEW YORK UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-08-27 至 2025-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10405461
关键词：
Ache Acupuncture Therapy Adult Adverse event Affect Analgesics Anti-Retroviral Agents Anticonvulsants Antidepressive Agents Blinded Chinese Traditional Medicine Chronic Clinical Clinical Trials Cooperative Group Data Diagnosis Diagnostic Distal Drug Side Effects Effectiveness FDA approved Generations Guidelines HIV Impairment Interview Literature Lower Extremity Measures Modeling Moxibustion Narcotic Analgesics Needles Neurologic Neuropathy Numbness Outcome Pain Pain intensity Pain management Patients Peripheral Nervous System Diseases Persons Pharmaceutical Preparations Pharmacotherapy Phase Placebo Control Placebos Population Prevalence Procedures Protocols documentation Quality of life Randomized Randomized Clinical Trials Randomized Controlled Clinical Trials Safety Sensory Severities Symptoms Testing Therapeutic Time United States National Institutes of Health Viral Load result Visit Waiting Lists active method base clinically relevant diaries distal sensory peripheral neuropathy effective intervention effective therapy effectiveness measure efficacy clinical trial efficacy study efficacy testing evidence base experience follow-up health related quality of life improved instrument neurotoxic non-opioid analgesic novel novel strategies novel therapeutic intervention pain scale painful neuropathy physical symptom predicting response prospective public health relevance sensory neuropathy side effect symptom management treatment group treatment response

项目摘要

Distal sensory peripheral neuropathy (DSP) is a chronic, debilitating painful condition affecting quality of life in 20%-50% of persons living with HIV. Treatments prescribed to manage DSP pain, such as nonnarcotic and narcotic analgesics, antidepressants and anticonvulsants, are largely ineffective. Our studies, using acupuncture and moxibustion (Acu/Moxa) to manage HIV DSP pain, show promise as an effective therapy. This study builds on preliminary data to test a novel approach, Acu/Moxa, to manage chronic lower-limb DSP pain in adults living with HIV. IMPACT: there are no FDA-approved agents for this indication in HIV. Effective management of DSP pain is an unmet therapeutic need for this population. Results from this study can provide patients and clinicians with an evidenced-based non-pharmacologic therapeutic option to manage this painful condition. The literature, our clinical experience, our preliminary studies and strength of our team provide a strong rationale to conduct a rigorous, randomized, blinded, placebo-controlled clinical trial of the efficacy of Acu/Moxa for HIV DSP pain that adheres to the CONSORT and STRICTA guidelines. Subjects with HIV-related lower limb DSP pain are randomized to one of four Conditions: 1) Standard (fixed) protocol Acu/Moxa, 2) Individualized (tailored) protocol Acu/Moxa, 3) Sham Acu/Placebo Moxa (control), or 4) WaitList (control). Subjects attend six weeks of twice weekly treatment sessions and 3 non-treatment follow-up sessions at weeks 9, 11, and 15. All subjects are assessed by a blinded diagnostic acupuncturist (DA) and those assigned to Conditions 1, 2 and 3 receive treatments by an unblinded treating acupuncturist (TA). Specific Aims are: #1 determine group differences in weekly average pain (Gracely Pain Scale) at the end of treatment (Tx) and end of follow-up (F/U); SA#2 determine group differences in improvement in specific sensory symptoms (Subjective Peripheral Neuropathy Screen and neurological sensory testing (NST)) and patient-rated effectiveness (Clinical Global Improvement, NIH PROMIS Pain Intensity and Health-Related Quality of Life (MOS-HIV)) at Tx and F/U; SA#3 determine group differences in safety profiles; and SA#4, explore how baseline measures, TCM diagnoses, NST and pain medication use predict response to treatment. The primary intent-to-treat analysis of group differences in within-subject longitudinal change from baseline to Tx and F/U uses linear mixed models for repeated measures (LMMrm) with fixed effects for DA, treatment group, time, their interactions with covariate adjustment for the level of the outcome at baseline (SA#1 & SA#2). Preliminary studies estimate of “medium” effect sizes for the Gracely Pain Scale and 20% attrition indicates the need for 196 subjects to achieve 80% power and 5% alpha to detect the superiority of one active treatment to control, and one active treatment to the other. Cross-sectional and longitudinal associations between TCM diagnoses, NST assessments and pain medication use with change in patient-rated effectiveness will use multiple correlation/regression for aim #4.

远端感觉性周围神经病变（DSP）是一种慢性、使人衰弱的疼痛性疾病，影响生活质量 20%-50%的艾滋病毒感染者。用于管理DSP疼痛的处方治疗，如非麻醉性和麻醉性镇痛药、抗抑郁药和抗惊厥药大多无效。我们的研究，使用针灸（Acu/艾草）治疗HIV DSP疼痛，显示出作为一种有效疗法的前景。本研究建立在初步数据的基础上，以测试一种新的治疗慢性下肢DSP的方法，Acu/艾草成人艾滋病毒感染者的痛苦。影响：没有FDA批准的药物用于HIV的这种适应症。有效 DSP疼痛的管理是该人群未满足的治疗需求。这项研究的结果可以提供患者和临床医生有一个基于证据的非药物治疗选择，以管理这种痛苦的条件文献、我们的临床经验、我们的初步研究和我们团队的实力提供了一个进行一项严格、随机、设盲、安慰剂对照的临床试验， Acu/艾草治疗HIV DSP疼痛，符合CONSORT和STRICTA指南。将患有HIV相关下肢DSP疼痛的受试者随机分配至以下四种情况之一：1）标准（固定）方案Acu/艾草，2）个体化（定制）方案Acu/艾草，3）假Acu/安慰剂艾草（对照），或4） WaitList（control）.受试者参加为期6周的每周两次治疗和3次非治疗随访第9、11和15周的会议。所有受试者均由盲法诊断穿刺医师（DA）进行评估，被分配到条件1、2和3的患者接受非盲治疗针灸师（TA）的治疗。具体目标是：#1在治疗结束时确定每周平均疼痛（Gracely疼痛量表）的组间差异治疗（Tx）和随访结束（F/U）; SA#2确定特定感觉症状（主观周围神经病变筛查和神经感觉测试（NST））和患者评定的有效性（临床总体改善，NIH PROMIS疼痛强度和健康相关 Tx和F/U时的生活质量（MOS-HIV））; SA#3确定安全性特征的组间差异; SA#4，探讨基线测量、中医诊断、NST和止痛药使用如何预测治疗反应。受试者内从基线至基线的纵向变化的组间差异的主要意向治疗分析 Tx和F/U使用重复测量线性混合模型（LMMrm），DA、治疗为固定效应组，时间，它们与基线结果水平的协变量调整的相互作用（SA#1 & SA#2）。初步研究估计Gracely疼痛量表和20%损耗的“中等”效应量表明需要196例受试者达到80%把握度和5% α，以检测一种活性药物的优效性治疗与对照，一种活性治疗与另一种活性治疗。横向和纵向关联中医诊断、NST评估和止痛药使用之间的差异，对于目标#4，有效性将使用多重相关/回归。