Michael A Überall, Christian Simanski, Mike Zellnig, Mariëlle Eerdekens, Sylvia Engelen, Myriam Heine, Fabienne Percot, Rita Freitas, Lucia Garcia Guerra, Tamara Quandel
{"title":"高浓度（179 mg）辣椒素贴片反复治疗手术或外伤性神经损伤后周围神经性疼痛的进行性反应：来自12个月德国CASPAR注册研究的结果","authors":"Michael A Überall, Christian Simanski, Mike Zellnig, Mariëlle Eerdekens, Sylvia Engelen, Myriam Heine, Fabienne Percot, Rita Freitas, Lucia Garcia Guerra, Tamara Quandel","doi":"10.1007/s40122-025-00752-4","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Peripheral neuropathic pain after nerve injury (PNI) caused by surgery or trauma can severely impact daily life. The high-concentration capsaicin patch (HCCP, 179 mg) is a topical therapy approved for peripheral neuropathic pain, including PNI. This study utilizes data from the German Pain e-Registry (GPeR) to investigate the real-world effectiveness of HCCP in managing PNI across multiple treatments over 1 year.</p><p><strong>Methods: </strong>CASPAR is a retrospective, non-interventional cohort study investigating patients with peripheral neuropathic pain treated with HCCP. The present analysis included 499 patients with PNI who received ≥ 1 HCCP with ≥ 12 months of follow-up. Key measures included pain intensity, quality of life (QoL), affective distress, sleep disturbances, and overall functioning. Furthermore, analgesic use and adverse events associated with HCCP treatment were evaluated.</p><p><strong>Results: </strong>The mean average daily pain intensity (API) decreased from 52.5 mm on the visual analog scale (VAS) at baseline to 21.5 mm at month 12 in patients receiving four HCCPs. At month 12, a ≥ 30% reduction in API was observed in 25.8%, 44.9%, 85.3%, and 97.8% of patients receiving one, two, three, and four HCCP treatments, respectively. Significant improvements were also noted in physical and mental QoL, sleep, mood, and daily functioning. Patients receiving three or four HCCP treatments maintained pain relief and symptom improvements over the 12-month period, whereas those who discontinued treatment after one or two treatments experienced symptom rebound. In addition, repeated HCCP treatments were associated with a marked reduction in concomitant analgesic use and an increase in days of normal activities. Adverse events were mild-to-moderate application-site reactions, consistent with the well-established safety profile of HCCP.</p><p><strong>Conclusions: </strong>HCCP treatment is associated with reductions in pain intensity and improvements in sleep, mood, and overall QoL in patients with PNI. These benefits are amplified with continued treatment and are accompanied by reduced use of concomitant analgesics and more days of usual activities, although a direct causal relationship cannot be confirmed within the context of this observational study.</p><p><strong>Clinical trial registration: </strong>EU PAS number: EUPAS1000000106.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1399-1416"},"PeriodicalIF":3.3000,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12279645/pdf/","citationCount":"0","resultStr":"{\"title\":\"Progressive Response of Repeated Treatment with High-Concentration (179 mg) Capsaicin Patch in Peripheral Neuropathic Pain After Surgical or Traumatic Nerve Injury: Findings from the 12-Month German CASPAR Registry Study.\",\"authors\":\"Michael A Überall, Christian Simanski, Mike Zellnig, Mariëlle Eerdekens, Sylvia Engelen, Myriam Heine, Fabienne Percot, Rita Freitas, Lucia Garcia Guerra, Tamara Quandel\",\"doi\":\"10.1007/s40122-025-00752-4\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Peripheral neuropathic pain after nerve injury (PNI) caused by surgery or trauma can severely impact daily life. The high-concentration capsaicin patch (HCCP, 179 mg) is a topical therapy approved for peripheral neuropathic pain, including PNI. This study utilizes data from the German Pain e-Registry (GPeR) to investigate the real-world effectiveness of HCCP in managing PNI across multiple treatments over 1 year.</p><p><strong>Methods: </strong>CASPAR is a retrospective, non-interventional cohort study investigating patients with peripheral neuropathic pain treated with HCCP. The present analysis included 499 patients with PNI who received ≥ 1 HCCP with ≥ 12 months of follow-up. Key measures included pain intensity, quality of life (QoL), affective distress, sleep disturbances, and overall functioning. Furthermore, analgesic use and adverse events associated with HCCP treatment were evaluated.</p><p><strong>Results: </strong>The mean average daily pain intensity (API) decreased from 52.5 mm on the visual analog scale (VAS) at baseline to 21.5 mm at month 12 in patients receiving four HCCPs. At month 12, a ≥ 30% reduction in API was observed in 25.8%, 44.9%, 85.3%, and 97.8% of patients receiving one, two, three, and four HCCP treatments, respectively. Significant improvements were also noted in physical and mental QoL, sleep, mood, and daily functioning. Patients receiving three or four HCCP treatments maintained pain relief and symptom improvements over the 12-month period, whereas those who discontinued treatment after one or two treatments experienced symptom rebound. In addition, repeated HCCP treatments were associated with a marked reduction in concomitant analgesic use and an increase in days of normal activities. Adverse events were mild-to-moderate application-site reactions, consistent with the well-established safety profile of HCCP.</p><p><strong>Conclusions: </strong>HCCP treatment is associated with reductions in pain intensity and improvements in sleep, mood, and overall QoL in patients with PNI. 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Progressive Response of Repeated Treatment with High-Concentration (179 mg) Capsaicin Patch in Peripheral Neuropathic Pain After Surgical or Traumatic Nerve Injury: Findings from the 12-Month German CASPAR Registry Study.
Introduction: Peripheral neuropathic pain after nerve injury (PNI) caused by surgery or trauma can severely impact daily life. The high-concentration capsaicin patch (HCCP, 179 mg) is a topical therapy approved for peripheral neuropathic pain, including PNI. This study utilizes data from the German Pain e-Registry (GPeR) to investigate the real-world effectiveness of HCCP in managing PNI across multiple treatments over 1 year.
Methods: CASPAR is a retrospective, non-interventional cohort study investigating patients with peripheral neuropathic pain treated with HCCP. The present analysis included 499 patients with PNI who received ≥ 1 HCCP with ≥ 12 months of follow-up. Key measures included pain intensity, quality of life (QoL), affective distress, sleep disturbances, and overall functioning. Furthermore, analgesic use and adverse events associated with HCCP treatment were evaluated.
Results: The mean average daily pain intensity (API) decreased from 52.5 mm on the visual analog scale (VAS) at baseline to 21.5 mm at month 12 in patients receiving four HCCPs. At month 12, a ≥ 30% reduction in API was observed in 25.8%, 44.9%, 85.3%, and 97.8% of patients receiving one, two, three, and four HCCP treatments, respectively. Significant improvements were also noted in physical and mental QoL, sleep, mood, and daily functioning. Patients receiving three or four HCCP treatments maintained pain relief and symptom improvements over the 12-month period, whereas those who discontinued treatment after one or two treatments experienced symptom rebound. In addition, repeated HCCP treatments were associated with a marked reduction in concomitant analgesic use and an increase in days of normal activities. Adverse events were mild-to-moderate application-site reactions, consistent with the well-established safety profile of HCCP.
Conclusions: HCCP treatment is associated with reductions in pain intensity and improvements in sleep, mood, and overall QoL in patients with PNI. These benefits are amplified with continued treatment and are accompanied by reduced use of concomitant analgesics and more days of usual activities, although a direct causal relationship cannot be confirmed within the context of this observational study.
Clinical trial registration: EU PAS number: EUPAS1000000106.
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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