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：
10153892
负责人：
JOYCE K ANASTASI
金额：
$ 70.39万
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 2023-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10153892
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 Controlled Clinical Trials 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 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、令人衰弱的疼痛性疾病，影响生活质量 20%-50% 的 HIV 感染者接受治疗 DSP 疼痛，例如非麻醉药物和药物。我们的研究使用的麻醉镇痛药、抗抑郁药和抗惊厥药基本上无效。针灸 (Acu/Moxa) 治疗 HIV DSP 疼痛有望成为一种有效的疗法。本研究以初步数据为基础，测试一种管理慢性下肢 DSP 的新方法 Acu/Moxa 影响：尚无 FDA 批准的药物可用于治疗 HIV 的这一适应症。 DSP 疼痛的管理是该人群未满足的治疗需求。本研究的结果可以提供这一点。患者和婴儿有基于证据的非药物治疗选择来控制这种痛苦文献、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信息。进行严格的、随机的、盲法的、安慰剂对照的临床试验的有效性的强有力的理由 Acu/Moxa 用于治疗 HIV DSP 疼痛，符合 CONSORT 和 STRICTA 指南。患有 HIV 相关下肢 DSP 疼痛的受试者被随机分配至四种情况之一：1) 标准（固定） Acu/Moxa 方案，2) 个体化（定制）Acu/Moxa 方案，3) Sham Acu/Placebo Moxa（对照），或 4) 等待名单（对照）。受试者参加为期六周的每周两次的治疗课程和 3 次非治疗随访。第 9、11 和 15 周进行。所有受试者均由盲法诊断针灸师 (DA) 进行评估，并属于条件 1、2 和 3 的患者接受非盲针灸治疗师 (TA) 的治疗。具体目标是： #1 确定每周平均疼痛（优雅疼痛量表）的组间差异治疗 (Tx) 和随访结束 (F/U) 确定特定改善的组间差异；感觉症状（主观周围神经病变筛查和神经感觉测试（NST））和患者评价的有效性（临床整体改善、NIH PROMIS 疼痛强度和健康相关 Tx 和 F/U 的生活质量 (MOS-HIV)；SA#3 确定安全性方面的组间差异；探索基线测量、中医诊断、NST 和止痛药物的使用如何预测治疗反应。对受试者内从基线到基线的纵向变化进行组间差异的主要意向治疗分析 Tx 和 F/U 使用线性混合模型进行重复测量 (LMMrm)，对 DA、治疗具有固定效应组、时间、它们与基线结果水平的协变量调整的相互作用（SA#1 和 SA#2) 的初步研究估计了 Gracely Pain Scale 的“中等”效应大小和 20% 的流失率。表示需要 196 名受试者达到 80% 功率和 5% alpha 才能检测一种活性物质的优越性治疗与控制，一种积极治疗与另一种治疗的横向和纵向关联。中医诊断、NST 评估和止痛药使用之间随患者评分变化的变化有效性将使用多重相关/回归来实现目标#4。