Heavon M Allen, Melinda M Holena, Lauren E Allen, SiNing Zhao, Renan C Castillo, Steven P Cohen, Robert W Hurley, Daniel O Scharfstein, Jennifer A Haythornthwaite, Srinivasa N Raja, Stephen T Wegener, Christine M Rini, Francis J Keefe, Jordan Bridges, Ron Reeder, Richard E Thompson, Dan Hanley, Claudia M Campbell
{"title":"一项随机、实用、比较有效性试验的研究设计和方案，评估改善膝关节骨关节炎疼痛（SKOAP）患者预后的顺序策略：保守治疗评估。","authors":"Heavon M Allen, Melinda M Holena, Lauren E Allen, SiNing Zhao, Renan C Castillo, Steven P Cohen, Robert W Hurley, Daniel O Scharfstein, Jennifer A Haythornthwaite, Srinivasa N Raja, Stephen T Wegener, Christine M Rini, Francis J Keefe, Jordan Bridges, Ron Reeder, Richard E Thompson, Dan Hanley, Claudia M Campbell","doi":"10.1016/j.semarthrit.2025.152834","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Treatment guidelines for knee osteoarthritis (KOA) vary across organizations, partly due to the lack of high-quality evidence. Experts disagree on the role of psychological management, pharmacologic treatments including opioids, and interventional therapies.</p><p><strong>Methods/design: </strong>The Sequenced strategy for Knee OsteoArthritis Pain (SKOAP) trial is a multi-site, randomized, pragmatic clinical trial that uses a two-phase sequential design to evaluate the effectiveness of several interventions in individuals reporting KOA pain. Described here is the protocol for Phase 1 of the trial sequence which focuses on conservative treatments. All participants receive Best Practices (BP), a guideline-based approach to care that includes physical therapies, alternative treatments, and over-the-counter medications. Participants are then randomized to one of three groups: (1) BP alone, (2) BP plus duloxetine (30-120 mg/day), or (3) BP plus duloxetine and painTRAINER, a web-based, Cognitive Behavioral Therapy (CBT)-informed pain coping skills training. Phase 1 aims to determine whether the combination of duloxetine and BP improves pain compared to BP alone, and whether the combination of painTRAINER, duloxetine and BP provides additional benefit compared to duloxetine combined with BP. The analysis will include a modified Intention to Treat (mITT) approach and two Per-Protocol (PP) analyses; Receipt of Prescription (PP-ROP) and Minimum Effective Dose (PP-MinED). A third aim of Phase 1 is to identify clinical characteristics, patient-level factors, and psychosocial phenotypes that predict short- and long-term outcomes.</p><p><strong>Discussion: </strong>Findings from Phase 1 of the SKOAP trial will provide evidence on the effectiveness of non-opioid pharmacologic and psychological interventions for the treatment of painful KOA beyond established best practices. It may also help refine personalized treatment strategies.</p>","PeriodicalId":21715,"journal":{"name":"Seminars in arthritis and rheumatism","volume":"75 ","pages":"152834"},"PeriodicalIF":4.4000,"publicationDate":"2025-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Study design and protocol of a randomized, pragmatic, comparative effectiveness trial evaluating a sequenced strategy for improving outcomes in people with knee osteoarthritis pain (SKOAP): Conservative treatment evaluation.\",\"authors\":\"Heavon M Allen, Melinda M Holena, Lauren E Allen, SiNing Zhao, Renan C Castillo, Steven P Cohen, Robert W Hurley, Daniel O Scharfstein, Jennifer A Haythornthwaite, Srinivasa N Raja, Stephen T Wegener, Christine M Rini, Francis J Keefe, Jordan Bridges, Ron Reeder, Richard E Thompson, Dan Hanley, Claudia M Campbell\",\"doi\":\"10.1016/j.semarthrit.2025.152834\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Treatment guidelines for knee osteoarthritis (KOA) vary across organizations, partly due to the lack of high-quality evidence. Experts disagree on the role of psychological management, pharmacologic treatments including opioids, and interventional therapies.</p><p><strong>Methods/design: </strong>The Sequenced strategy for Knee OsteoArthritis Pain (SKOAP) trial is a multi-site, randomized, pragmatic clinical trial that uses a two-phase sequential design to evaluate the effectiveness of several interventions in individuals reporting KOA pain. Described here is the protocol for Phase 1 of the trial sequence which focuses on conservative treatments. All participants receive Best Practices (BP), a guideline-based approach to care that includes physical therapies, alternative treatments, and over-the-counter medications. Participants are then randomized to one of three groups: (1) BP alone, (2) BP plus duloxetine (30-120 mg/day), or (3) BP plus duloxetine and painTRAINER, a web-based, Cognitive Behavioral Therapy (CBT)-informed pain coping skills training. Phase 1 aims to determine whether the combination of duloxetine and BP improves pain compared to BP alone, and whether the combination of painTRAINER, duloxetine and BP provides additional benefit compared to duloxetine combined with BP. The analysis will include a modified Intention to Treat (mITT) approach and two Per-Protocol (PP) analyses; Receipt of Prescription (PP-ROP) and Minimum Effective Dose (PP-MinED). A third aim of Phase 1 is to identify clinical characteristics, patient-level factors, and psychosocial phenotypes that predict short- and long-term outcomes.</p><p><strong>Discussion: </strong>Findings from Phase 1 of the SKOAP trial will provide evidence on the effectiveness of non-opioid pharmacologic and psychological interventions for the treatment of painful KOA beyond established best practices. It may also help refine personalized treatment strategies.</p>\",\"PeriodicalId\":21715,\"journal\":{\"name\":\"Seminars in arthritis and rheumatism\",\"volume\":\"75 \",\"pages\":\"152834\"},\"PeriodicalIF\":4.4000,\"publicationDate\":\"2025-09-23\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Seminars in arthritis and rheumatism\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.semarthrit.2025.152834\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"RHEUMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Seminars in arthritis and rheumatism","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.semarthrit.2025.152834","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"RHEUMATOLOGY","Score":null,"Total":0}
Study design and protocol of a randomized, pragmatic, comparative effectiveness trial evaluating a sequenced strategy for improving outcomes in people with knee osteoarthritis pain (SKOAP): Conservative treatment evaluation.
Background: Treatment guidelines for knee osteoarthritis (KOA) vary across organizations, partly due to the lack of high-quality evidence. Experts disagree on the role of psychological management, pharmacologic treatments including opioids, and interventional therapies.
Methods/design: The Sequenced strategy for Knee OsteoArthritis Pain (SKOAP) trial is a multi-site, randomized, pragmatic clinical trial that uses a two-phase sequential design to evaluate the effectiveness of several interventions in individuals reporting KOA pain. Described here is the protocol for Phase 1 of the trial sequence which focuses on conservative treatments. All participants receive Best Practices (BP), a guideline-based approach to care that includes physical therapies, alternative treatments, and over-the-counter medications. Participants are then randomized to one of three groups: (1) BP alone, (2) BP plus duloxetine (30-120 mg/day), or (3) BP plus duloxetine and painTRAINER, a web-based, Cognitive Behavioral Therapy (CBT)-informed pain coping skills training. Phase 1 aims to determine whether the combination of duloxetine and BP improves pain compared to BP alone, and whether the combination of painTRAINER, duloxetine and BP provides additional benefit compared to duloxetine combined with BP. The analysis will include a modified Intention to Treat (mITT) approach and two Per-Protocol (PP) analyses; Receipt of Prescription (PP-ROP) and Minimum Effective Dose (PP-MinED). A third aim of Phase 1 is to identify clinical characteristics, patient-level factors, and psychosocial phenotypes that predict short- and long-term outcomes.
Discussion: Findings from Phase 1 of the SKOAP trial will provide evidence on the effectiveness of non-opioid pharmacologic and psychological interventions for the treatment of painful KOA beyond established best practices. It may also help refine personalized treatment strategies.
期刊介绍：
Seminars in Arthritis and Rheumatism provides access to the highest-quality clinical, therapeutic and translational research about arthritis, rheumatology and musculoskeletal disorders that affect the joints and connective tissue. Each bimonthly issue includes articles giving you the latest diagnostic criteria, consensus statements, systematic reviews and meta-analyses as well as clinical and translational research studies. Read this journal for the latest groundbreaking research and to gain insights from scientists and clinicians on the management and treatment of musculoskeletal and autoimmune rheumatologic diseases. The journal is of interest to rheumatologists, orthopedic surgeons, internal medicine physicians, immunologists and specialists in bone and mineral metabolism.
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