Effect of TENS on Knee Osteoarthritis Pain, Hyperalgesia, and Function

TENS 对膝骨关节炎疼痛、痛觉过敏和功能的影响

• 批准号: 7289659
• 负责人: Barbara Rakel
• 金额: $ 7.31万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-07-13 至 2009-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7289659
• 关键词: Activities of Daily Living; Address; Adverse effects; Affect; Aftercare; Age; American; Animal Model; Animals; Arthritis; Basic Science; Behavior; Chronic; Clinical; Clinical Research; Condition; Consensus; Cyclooxygenase Inhibitors; Data; Degenerative polyarthritis; Devices; Double-Blind Method; Drug Interactions; Effectiveness; Elderly; Electrodes; Frequencies; Funding; Future; Goals; Health Personnel; Heating; Hyperalgesia; Individual; Intake; Intervention; Knee; Knee Osteoarthritis; Medication Management; Methods; Movement; Musculoskeletal; Outcome; Outcome Measure; Pain; Pain Threshold; Pain management; Patients; Perception; Pharmaceutical Preparations; Physiological; Placebos; Placement; Purpose; Quality of life; Ramp; Randomized; Randomized Controlled Trials; Research; Research Personnel; Rest; Review, Systematic (PT); Risk; Score; Screening procedure; Secondary Hyperalgesias; Skin; Standards of Weights and Measures; Stimulus; Telephone; Testing; Time; Transcutaneous Electric Nerve Stimulation; Translating; Treatment Protocols; Visit; cost; disability; functional status; healthy volunteer; heat stimulus; improved; innovation; pressure; prospective; research study; response; spontaneous pain

DESCRIPTION (provided by applicant): Background: Osteoarthritis (OA) is a common, painful, and limiting condition that affects an estimated 20 million Americans. Identification of effective non-pharmacologic strategies is critical for control of OA pain because of the increased intake of medications in older adults with this condition and recent concerns regarding COX inhibitors. Transcutaneous electrical nerve stimulation (TENS) is effective for pain relief in patients with OA and may be particularly effective for the knee. However, more standardized treatment protocols, stimulation parameters, and outcome measures are needed. Studies in animals with arthritis of the knee show that low and high frequency TENS has no effect on spontaneous pain behaviors but reduces hyperalgeisa (increased pain in response to noxious stimuli). Purpose: The primary aim of this study is to compare the effect of high (100Hz) and low (10Hz) frequency TENS to placebo in 120 patients with OA (40 per group) on primary and secondary hyperalgesia, subjective pain scores, and function. We hypothesize that TENS will reduce hyperalgesia and pain with movement, resulting in increased function. Another concern is that there is not an appropriate placebo for TENS. Since TENS delivers an electrical current through the skin to produce pain relief, patients can typically feel the stimulation under the electrodes. Standard placebo-TENS does not deliver a current. A new device has the capability of mimicking a true TENS application. The secondary aim of this study is to compare the effect of short burst placebo-TENS (new device), standard placebo-TENS, and active TENS in 90 healthy volunteers (30 per group) on perception of intervention, and pain thresholds and temporal summation to heat and pressure stimuli. Methods: Two prospective, randomized, double blind, controlled trials will be conducted. Subjects in both trials will receive telephone screening and a single visit for intervention and testing. Trial #1 will assess pain thresholds and temporal summation to pressure and heat stimuli before and after TENS application and perception of treatment after TENS. Trial #2 will assess VAS pain scores, pain thresholds and temporal summation to force, pressure, and heat stimuli, and TUG function tests before and after TENS application. Significance: This research will provide pilot data for future R01 funding to explore the longitudinal effect of TENS on chronic OA pain, functional ability and quality of life. It is the first to test a new placebo-TENS device and systematically examine the effect of TENS on a variety of physiological parameters (primary and secondary hyperalgesia) and clinical outcome measures (subjective pain at rest and with movement, function) in knee OA. These studies will further allow us to translate basic science experiments previously performed in animal models of arthritis to the clinical setting. By achieving a better understanding of the effect of TENS on pain associated with osteoarthritis, health care providers will be better able to use this non-drug strategy to improve pain control for older adults who are at risk for drug interactions and medication side effects. This will improve the functional status and independence of older adults suffering from this chronic, painful, limiting condition.

描述（申请人提供）：背景：骨关节炎（OA）是一种常见、疼痛和限制性疾病，影响约2000万美国人。有效的非药物策略的识别是控制OA疼痛的关键，因为这种情况下，老年人的药物摄入量增加，最近的关注考克斯抑制剂。经皮神经电刺激（TENS）可有效缓解OA患者的疼痛，对膝关节尤其有效。然而，需要更标准化的治疗方案、刺激参数和结果测量。对膝关节炎动物的研究表明，低频和高频TENS对自发性疼痛行为没有影响，但可减少痛觉过敏（对伤害性刺激的反应增加疼痛）。目的：本研究的主要目的是在120例OA患者（每组40例）中比较高频（100 Hz）和低频（10 Hz）TENS与安慰剂对原发性和继发性痛觉过敏、主观疼痛评分和功能的影响。我们假设TENS将减少痛觉过敏和运动疼痛，从而增加功能。另一个问题是，没有一个适当的安慰剂TENS。由于TENS通过皮肤输送电流以缓解疼痛，因此患者通常可以感受到电极下的刺激。标准安慰剂-TENS不输送电流。一种新的设备具有模仿真正的TENS应用的能力。本研究的次要目的是在90名健康志愿者（每组30名）中比较短阵发安慰剂-TENS（新器械）、标准安慰剂-TENS和活性TENS对干预感知、疼痛阈值和对热和压力刺激的时间总和的影响。方法：将进行两项前瞻性、随机、双盲、对照试验。两项试验中的受试者将接受电话筛选和单次访视，以进行干预和检测。试验#1将评估在TENS应用之前和之后的疼痛阈值和对压力和热刺激的时间总和以及TENS之后的治疗感知。试验#2将评估VAS疼痛评分、疼痛阈值和力、压力和热刺激的时间总和，以及TENS应用前后的TUG功能测试。重要性：这项研究将为未来的R 01基金提供试点数据，以探索TENS对慢性OA疼痛，功能能力和生活质量的纵向影响。这是第一个测试新的安慰剂-TENS设备，并系统地检查TENS对膝关节OA的各种生理参数（原发性和继发性痛觉过敏）和临床结局指标（休息时和运动时的主观疼痛，功能）的影响。这些研究将进一步使我们能够将以前在关节炎动物模型中进行的基础科学实验转化为临床环境。通过更好地了解TENS对骨关节炎相关疼痛的影响，医疗保健提供者将能够更好地使用这种非药物策略来改善老年人的疼痛控制，这些老年人有药物相互作用和药物副作用的风险。这将改善患有这种慢性，痛苦，限制性疾病的老年人的功能状态和独立性。