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.

远端感觉周围神经病（DSP）是一种慢性，令人衰弱的疼痛状况，影响生活质量在20％-50％的艾滋病毒患者中。规定管理DSP疼痛的治疗麻醉镇痛药，抗抑郁药和抗惊厥药在很大程度上无效。我们的研究，使用针灸和Moxibustion（ACU/MOXA）管理HIV DSP疼痛，显示出有效疗法的希望。这项研究以初步数据为基础，以测试一种新方法ACU/MOXA来管理慢性下LIMB DSP 患有艾滋病毒的成年人的疼痛。影响：艾滋病毒中没有FDA批准的药物。有效的 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具有基于证据的非药物治疗选择的患者和临床医生可以控制这种痛苦健康）状况。文献，我们的临床经验，我们的初步研究和团队的力量提供了强烈的理由进行严格，随机，盲，安慰剂对照的临床试验的效率符合配偶和严格指南的HIV DSP疼痛的ACU/MOXA。与HIV相关的下肢DSP疼痛的受试者被随机分为四个条件之一：1）标准（固定）协议ACU/MOXA，2）个性化（量身定制的）协议ACU/MOXA，3）假ACU/安慰剂MOXA（对照）或4）候补名单（控制）。受试者参加六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。所有受试者均由盲目的诊断针灸师（DA）和那些分配给条件1、2和3的条件的人通过一个未盲的针灸师（TA）接受治疗。具体目的是：＃1确定每周平均疼痛（GraClieled疼痛量表）的群体差异治疗（TX）和随访结束（F/U）； SA＃2确定具体改进的群体差异感觉症状（主观周围神经病筛查和神经感觉测试（NST））和患者评价的有效性（临床全球改善，NIH Promis疼痛强度和与健康有关在TX和F/U处的生活质量（MOS-HIV））； SA＃3确定安全概况的群体差异；和SA＃4，探索基线测量，TCM诊断，NST和止痛药物的使用如何预测对治疗的反应。从基线到受试者内部纵向变化的群体差异的主要意图对治疗分析 TX和F/U使用线性混合模型进行重复测量（LMMRM），对DA，处理固定效果小组，时间，与基线结果水平的协变量调整相互作用（SA＃1＆ SA＃2）。初步研究估计了疼痛量表的“中”效应大小和20％的损耗表示需要196名受试者实现80％的功率，而5％的alpha需要检测一个活动的优势治疗以控制，另一种主动治疗。横截面和纵向关联在TCM诊断，NST评估和止痛药物使用情况下，患者评分的变化有效性将对目标4使用多个相关/回归。