Evidence map›Paper›PMID 41061328›Full record

ArticleSeminars in arthritis and rheumatism2025

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.

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 and 9 more

Abstract readClinical Trial Protocol
In one paragraph

Article in Seminars in arthritis and rheumatism, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Heavon M AllenJohns Hopkins University, School of Medicine, Department of Psychiatry and Behavioral Sciences, 5510 Nathan Shock Drive, Ste 100, Baltimore, MD 21224, USA.
Melinda M HolenaJohns Hopkins University, School of Medicine, Department of Psychiatry and Behavioral Sciences, 5510 Nathan Shock Drive, Ste 100, Baltimore, MD 21224, USA.
Lauren E AllenJohns Hopkins University, School of Public Health, Major Extremity Trauma Research Consortium, 415N. Washington Street, Baltimore, MD 21231, USA.
SiNing ZhaoJohns Hopkins University, School of Public Health, Major Extremity Trauma Research Consortium, 415N. Washington Street, Baltimore, MD 21231, USA.
Renan C CastilloJohns Hopkins University, School of Public Health, Major Extremity Trauma Research Consortium, 415N. Washington Street, Baltimore, MD 21231, USA.
Steven P CohenNorthwestern University Feinberg School of Medicine, Departments of Anesthesiology, Neurology, Physical Medicine & Rehabilitation, Psychiatry and Neurological Surgery, 259 E Erie St Ste 1400, Chicago, IL 60611, USA.
Robert W HurleyWake Forest University School of Medicine, Departments of Anesthesiology, Translational Neuroscience, and Public Health; Pain Outcomes Lab; Medical Center Blvd, Winston-Salem, NC 27157, USA.
Daniel O ScharfsteinUniversity of Utah, School of Medicine, Department of Population Health Sciences, Division of Biostatistics, 295 Chipeta Way, Salt Lake City, UT 84108, USA.
Jennifer A HaythornthwaiteJohns Hopkins University, School of Medicine, Department of Psychiatry and Behavioral Sciences, 5510 Nathan Shock Drive, Ste 100, Baltimore, MD 21224, USA.
Srinivasa N RajaJohns Hopkins University, School of Medicine, Department of Anesthesia and Critical Care Medicine, Division of Pain Medicine, 600N. Wolfe St., Baltimore, MD 21287, USA.
Stephen T WegenerJohns Hopkins University School of Medicine, Department of Physical Medicine and Rehabilitation, 600N. Wolfe Street, Baltimore, MD 2128A7, USA.
Christine M RiniNorthwestern University Feinberg School of Medicine, Department of Medical Social Science, 625N. Michigan Avenue, Chicago, IL 60611; Robert H. Lurie Comprehensive Cancer Center of Northwestern University; 675N St Clair St Fl 21 Ste 100, Chicago, IL 60611, USA.
Francis J KeefeDuke University, School of Medicine, Departments of Psychiatry and Behavioral Sciences, Psychology and Neuroscience, Medicine, and Anesthesiology, 2200W Main St, Suite 340, Durham, NC 27705, USA.
Jordan BridgesUniversity of Utah, Utah Data Coordinating Center, 295 Chipeta Way, Salt Lake City, UT 84108, USA.
Ron ReederUniversity of Utah, School of Medicine, Department of Pediatrics, 295 Chipeta Way, Salt Lake City, UT 84108, USA.
Richard E ThompsonJohns Hopkins University, School of Medicine, Johns Hopkins Institute for Clinical & Translational Research, Brian Injury Outcomes (BIOS), 750 E. Pratt St., 16th floor, Baltimore, MD 21202, USA.
Dan HanleyJohns Hopkins University, School of Medicine, Johns Hopkins Institute for Clinical & Translational Research, Brian Injury Outcomes (BIOS), 750 E. Pratt St., 16th floor, Baltimore, MD 21202, USA.
Claudia M CampbellJohns Hopkins University, School of Medicine, Department of Psychiatry and Behavioral Sciences, 5510 Nathan Shock Drive, Ste 100, Baltimore, MD 21224, USA. Electronic address: ccampb41@jhmi.edu.
SKOAP Consortium

Funding

COVID-19 Supplement - Center for Innovative TRIals in ChilDrEN and AdulTs (TRIDENT)U24TR001608 · NCATS · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K., BERNARD, GORDON RAPHAEL · 2016 to 2022
$177.0M
Utah Trial Innovation CenterU24TR001597 · NCATS · UNIVERSITY OF UTAH · PI DEAN, JONATHAN MICHAEL · 2016 to 2022
$39.6M
Johns Hopkins-Tufts Trial Innovation Center HEAL Pain ERN SupplementU24TR001609 · NCATS · JOHNS HOPKINS UNIVERSITY · PI HANLEY, DANIEL F · 2016 to 2022
$36.3M
Improving Clinical trial Education, Recruitment, and Enrollment at CTSA Hubs (I-CERCH) - HEAL SupplementU24TR001579 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI HARRIS, PAUL A., WILKINS, CONSUELO HOPKINS · 2016 to 2022
$34.1M
Increasing Participant Diversity in a 'Sequenced-Strategy to Improve Outcomes in people with Knee Osteoarthritis Pain (SKOAP)UH3AR077360 · NIAMS · JOHNS HOPKINS UNIVERSITY · PI CAMPBELL, CLAUDIA MICHELLE, CASTILLO, RENAN C · 2020 to 2023
$13.8M
HEAL Sickle Cell and CDE SupplementU24TR004315 · NCATS · UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH · PI DWYER, JAMIE P., SWARD, KATHERINE ANN · 2022 to 2025
$13.8M
HEAL Clinical Coordinating Resource Center for the Pain Management Effectiveness Research NetworkU24TR004314 · NCATS · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K., GREENBERG, RACHEL G · 2022 to 2025
$10.8M
Johns Hopkins Statistical and Safety Resource Center-HEAL PAIN ERNU24TR004316 · NCATS · JOHNS HOPKINS UNIVERSITY · PI HANLEY, DANIEL F · 2022 to 2025
$7.2M
STEPS: Supporting Trials for Effective Pain SolutionsU24TR004317 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI HARRIS, PAUL A., WILKINS, CONSUELO HOPKINS · 2022 to 2025
$4.0M
NCATS NIH HHS U24 TR001579NCATS NIH HHS U24 TR001597NCATS NIH HHS U24 TR001608NCATS NIH HHS U24 TR001609NCATS NIH HHS U24 TR004314NCATS NIH HHS U24 TR004315NCATS NIH HHS U24 TR004316NCATS NIH HHS U24 TR004317NIAMS NIH HHS UH3 AR077360
6 · The paper itself

Abstract

backgroundTreatment 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/

designThe 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.

Indexed as

Conservative TreatmentDuloxetine HydrochlorideOsteoarthritis, KneePain ManagementCognitive Behavioral TherapyComparative Effectiveness ResearchFemaleHumansMaleMiddle AgedPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicTreatment OutcomeDuloxetine HydrochlorideCBTChronic painCognitive behavioral therapyDuloxetineKnee osteoarthritisPragmatic clinical trials

Identifiers

PMID41061328
PMCPMC12766632

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.