{"title":"Reducing Pain and Improving Mobility Using Haptic Patch Technology: Results of the RESTORE Study.","authors":"Janet Fason, Peter Hurwitz, Jeffrey Gudin","doi":"10.1007/s40122-025-00780-0","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Acute and chronic pain affects patients' overall health status and well-being, and the assessment and treatment of these patients can be challenging. Unfortunately, many patients fail to respond to the available multimodal treatment options, with some even failing advanced interventions including surgery. Therefore, alternative approaches to pain treatment represent an unmet medical need. Haptic vibrotactile trigger technology (VTT) is designed to target nociceptive pathways and is theorized to disrupt the neuromatrix of pain. The aim of this study was to evaluate the analgesic effects of a wearable VTT haptic patch in adults diagnosed with mild-to-moderate acute or chronic pain.</p><p><strong>Methods: </strong>This was a prospective, randomized, controlled, double-blind study. A total of 118 research participants (58 male, 60 female) met the inclusion criteria and were enrolled in the study. Participants were randomly assigned to either a treatment group receiving the active patch (N = 64) or a control group which used a similar-appearing vehicle/placebo patch (N = 54). Assessments were performed at baseline (day 0), day 7, and day 14. Reduction in pain severity and interference was assessed using the validated Brief Pain Inventory (BPI), and range of motion/flexibility assessment was performed using the Schober (only for low back pain), goniometer, and bubble inclinometer tests. Data for the active patch user group and the control group were aggregated and compared over the 14-day time frame of the study.</p><p><strong>Results: </strong>The active patch user group had significantly greater improvement in pain severity and reduction in pain interference; in addition, the active patch group showed greater objective improvement in range of motion (ROM)/flexibility than the control group at day 7 and day 14.</p><p><strong>Conclusion: </strong>These findings suggest that this non-pharmacological, noninvasive, topical VTT haptic patch (FREEDOM Super Patch with VTT) can reduce pain severity and increase ROM/flexibility. Considering the multitude of serious adverse effects associated with standard pharmacological pain treatments, clinicians should consider this readily available, over-the-counter VTT patch as a potential first-line or adjunct therapy to treat pain.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT06505005.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":""},"PeriodicalIF":3.3000,"publicationDate":"2025-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pain and Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40122-025-00780-0","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Introduction: Acute and chronic pain affects patients' overall health status and well-being, and the assessment and treatment of these patients can be challenging. Unfortunately, many patients fail to respond to the available multimodal treatment options, with some even failing advanced interventions including surgery. Therefore, alternative approaches to pain treatment represent an unmet medical need. Haptic vibrotactile trigger technology (VTT) is designed to target nociceptive pathways and is theorized to disrupt the neuromatrix of pain. The aim of this study was to evaluate the analgesic effects of a wearable VTT haptic patch in adults diagnosed with mild-to-moderate acute or chronic pain.
Methods: This was a prospective, randomized, controlled, double-blind study. A total of 118 research participants (58 male, 60 female) met the inclusion criteria and were enrolled in the study. Participants were randomly assigned to either a treatment group receiving the active patch (N = 64) or a control group which used a similar-appearing vehicle/placebo patch (N = 54). Assessments were performed at baseline (day 0), day 7, and day 14. Reduction in pain severity and interference was assessed using the validated Brief Pain Inventory (BPI), and range of motion/flexibility assessment was performed using the Schober (only for low back pain), goniometer, and bubble inclinometer tests. Data for the active patch user group and the control group were aggregated and compared over the 14-day time frame of the study.
Results: The active patch user group had significantly greater improvement in pain severity and reduction in pain interference; in addition, the active patch group showed greater objective improvement in range of motion (ROM)/flexibility than the control group at day 7 and day 14.
Conclusion: These findings suggest that this non-pharmacological, noninvasive, topical VTT haptic patch (FREEDOM Super Patch with VTT) can reduce pain severity and increase ROM/flexibility. Considering the multitude of serious adverse effects associated with standard pharmacological pain treatments, clinicians should consider this readily available, over-the-counter VTT patch as a potential first-line or adjunct therapy to treat pain.
急性和慢性疼痛影响患者的整体健康状况和福祉，这些患者的评估和治疗可能具有挑战性。不幸的是，许多患者对现有的多模式治疗方案没有反应，有些甚至失败了先进的干预措施，包括手术。因此，疼痛治疗的替代方法代表了未满足的医疗需求。触觉振动触觉触发技术（VTT）是针对伤害感知通路而设计的，理论上可以破坏疼痛的神经基质。本研究的目的是评估可穿戴式VTT触觉贴片对诊断为轻度至中度急性或慢性疼痛的成人的镇痛效果。方法：前瞻性、随机、对照、双盲研究。共有118名研究参与者（男性58名，女性60名）符合纳入标准并入选本研究。参与者被随机分配到接受活性贴片的治疗组（N = 64）或使用外观相似的载体/安慰剂贴片的对照组（N = 54）。在基线（第0天）、第7天和第14天进行评估。使用经过验证的简短疼痛量表（BPI）评估疼痛严重程度和干扰的减轻程度，并使用Schober（仅用于腰痛）、测角仪和气泡倾角仪测试进行活动范围/灵活性评估。在14天的研究时间框架内，对活跃贴片使用者组和对照组的数据进行汇总和比较。结果：主动贴片使用组在疼痛严重程度和疼痛干扰程度上均有显著性改善；此外，在第7天和第14天，主动贴片组在活动范围(ROM)/灵活性方面比对照组有更大的客观改善。结论：这些研究结果表明，这种非药物，无创，局部VTT触觉贴片（FREEDOM Super patch with VTT）可以减轻疼痛严重程度并增加ROM/灵活性。考虑到与标准药物疼痛治疗相关的大量严重不良反应，临床医生应该考虑将这种现成的非处方VTT贴片作为治疗疼痛的潜在一线或辅助疗法。试验注册：ClinicalTrials.gov识别码，NCT06505005。
期刊介绍：
Pain and Therapy is an international, open access, peer-reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of pain therapies and pain-related devices. Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also encouraged.
Areas of focus include, but are not limited to, acute pain, cancer pain, chronic pain, headache and migraine, neuropathic pain, opioids, palliative care and pain ethics, peri- and post-operative pain as well as rheumatic pain and fibromyalgia.
The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports, trial protocols, short communications such as commentaries and editorials, and letters. The journal is read by a global audience and receives submissions from around the world. Pain and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
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