The DOI matches its Crossref record; 111 of the 113 references it cites were found in a registry or an index.
Customization of Pain Treatments: Single-Case Design and Analysis
Abstract
The aim of this paper is to acquaint pain researchers and practitioners with recent developments in the single-case experimental approach and their potential to allow for tailoring the treatment and its evaluation to the specific complaints, aptitudes, or profile of the individual patient, without violating the canons of good science and practice. After contrasting the single-case experimental approach and the case-study approach, we show the possibilities of customization in design, measurement, and test statistics. This is done by distinguishing 2 types of single-case designs--alternation designs and phase designs--and 2 types of replication strategies--simultaneous replications and sequential replications. In addition, tailor-made randomization tests are proposed for alternation, phase, and simultaneous replication designs and the combining of P values to perform a meta-analysis on designs that are sequentially replicated. With our emphasis on: 1) randomization in the design; 2) the possibilities for a statistical test (together with the determination of power and the calculation of effect sizes); 3) the importance of reliable and valid measurement; and 4) the role of replication, we demonstrate how internal validity, statistical-conclusion validity, construct validity, and external validity concerns can be dealt with within a single-case experimental approach framework. Finally, the many research examples and references to clinical work illustrate the usefulness of the approach.
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“SCED studies can provide a clear understanding of change in outcomes and processes at the individual level, and a perspective on therapeutic mechanisms that considerably expands upon findings from RCTs (Onghena & Edgington, 2005;Vlaeyen et al., 2020).”
From Acceptance and Commitment Therapy for women living with Vulvodynia: A single-case experimental design study of a treatment delivered online (2022) · cites this paper as Onghena & Edgington, 2005
In the citing paper
“Compared with RCTs, n-of-1 study designs use repeated measurements to provide a more fine-graded, time-sensitive and context-sensitive picture of individual trajectories and pattern, thus allowing to evaluate effects at the within-person level.23”
From Development, evaluation and implementation of a digital behavioural health treatment for chronic pain: study protocol of the multiphase DAHLIA project (2022) · cites this paper as [23]
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Åkerblom, S., Perrin, S., Fischer, M. R., & McCracken, L. M. (2022) · Scandinavian Journal of Pain · doi:10.1515/sjpain-2021-0100 · Cited by 9
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“Typically, there are five overarching categories that each have subcategories on their basic form (cf. classification by Onghena and Edgington, 2005): Phase, alternation, multiple baseline, changing criterion, and hybrid.”
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“Single-case designs are increasingly recognized as a valuable addition to randomized controlled trials for studying the feasibility and potential effectiveness of interventions, in particular for rare diseases like SSc (Onghena & Edgington, 2005; Gupta, Faughnan, Tomlinson, & Bayoumi, 2011).”
BackgroundManolov, R. (2017) · Anuario de Psicología/The UB Journal of Psychology · doi:10.1016/j.anpsic.2017.05.004 · Cited by 11
“The ATD has been called an alternation design (Onghena & Edgington, 2005), a comparison design (Hammond & Gast, 2010) and a comparing interventions design (Wolery et al., 2011).”
MethodInfluentialFengler, R. K. B., Jacobs, J. W. G., Bac, M., van Wijck, A. J. M., & van Meeteren, N. L. U. (2006) · Clinical Rheumatology · doi:10.1007/s10067-006-0297-z · Cited by 9
“single-case experiments have higher practicality as compared to RCTs, and therefore, are more useful to demonstrate accountability in a clinical setting on a more regular basis [16].”
BackgroundNonparametric meta-analysis for single-case research: Confidence intervals for combined effect sizes
Michiels, B., & Onghena, P. (2018) · Behavior Research Methods · doi:10.3758/s13428-018-1044-5 · Cited by 9
“…as an appropriate statistical test to evaluate treatment effects in randomized SCEs (e.g., Bulté & Onghena, 2008; Edgington, 1967; Ferron & Levin, 2014; Heyvaert & Onghena, 2014; Levin, Ferron, & Kratochwill, 2012; Levin, Marascuilo, & Hubert, 1978; Onghena, 1992; Onghena & Edgington, 1994, 2005).”
Self-citationThe Effect of Computer-Assisted Cognitive Rehabilitation on Working Memory in Children with ADHD
Robatmili, S. (2019) · International Journal of Psychology · doi:10.24200/ijpb.2018.115071 · Cited by 9
“It extends the basic single case AB phase design by implementing several AB designs simultaneously to different people, behaviors, or settings (Ferron & Scott, 2005; Onghena & Edgington, 2005).”
MethodCederberg, J. T., Bartels, S. L., Thulin, M., Beeckman, M., Wicksell, R. K., & Goubert, L. (2024) · Clinical Journal of Pain · doi:10.1097/ajp.0000000000001200 · Cited by 9
“56 Aside from psychological fl exibility, another resilience factor of interest for future investigation is self-ef fi cacy, for which an association with CPSP has been demonstrated.”
BackgroundThe dynamics of pain avoidance: the exploration–exploitation dilemma
Krypotos, A., Crombez, G., & Vlaeyen, J. W. S. (2024) · Pain · doi:10.1097/j.pain.0000000000003222 · Cited by 8
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“The idea proposed in Solmi et al. (2012) is to estimate the time functional shape of observations separately for the sub-datasets related to the different treatments, using a nonparametric smoother, and then to use a summary statistic which is able to measure the difference among the several smoothed time-processes.”
Self-citationEpilogue to the Special Topic Series
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Tate, R. L., Perdices, M., Rosenkoetter, U., McDonald, S., Togher, L., Shadish, W. R., Horner, R. H., Kratochwill, T. R., Barlow, D. H., Kazdin, A. E., et al. (2019) · Pratiques Psychologiques · doi:10.1016/j.prps.2019.03.001 · Cited by 10
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Self-citationBrief report: The effectiveness of Dutch Cell Dogs: A multiple case experimental study
Offermans, J. E., Duindam, H. M., Asscher, J. J., Stams, G. J. J. M., & Creemers, H. E. (2020) · Clinical Child Psychology and Psychiatry · doi:10.1177/1359104520940744 · Cited by 7
“More assessments improve the stability of mean-levels per phase and randomization of baseline periods helps to rule out alternative explanations for intervention effects (Borckardt et al., 2008; Onghena & Edgington, 2005).”
Bontinck, J., den Hollander, M., Kaas, A., de Jong, J. D., & Timmers, I. (2022) · Journal of Clinical Medicine · doi:10.3390/jcm11051360 · Cited by 7
Morley, S. (2015) · Scandinavian Journal of Pain · doi:10.1016/j.sjpain.2015.02.004 · Cited by 7
“andomisation also offers the single case experimenter the powrful analytic tool of formal randomisation tests [7].”
Langenberg, B., Wurpts, I. C., Geuke, G. G. M., & Onghena, P. (2022) · Evaluation & the Health Professions · doi:10.1177/01632787211067533 · Cited by 7
“Therefore, by its emphasis on experimental manipulation and measurement, single-case experimental research is distinct from observational single-case time series research and qualitative case studies (Onghena & Edgington, 2005).”
MethodSelf-citationScholten, S., Herzog, P., Glombiewski, J. A., & Kaiser, T. (2024) · Pain · doi:10.1097/j.pain.0000000000003363 · Cited by 9
de Zoete, R. M. J., Nikles, J., Coombes, J. S., Onghena, P., & Sterling, M. M. (2022) · Disability and Rehabilitation · doi:10.1080/09638288.2022.2127937 · Cited by 6
Self-citationRandomization tests for ABAB designs: comparing-data-division- specific and common distributions.
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Lutz, W., Glombiewski, J. A., Deisenhofer, A., & Rubel, J. A. (2021) · Elsevier eBooks · doi:10.1016/b978-3-437-21352-6.00030-4 · Cited by 6
Wijnhoven, L. A. M. W., Engels, R. C. M. E., Onghena, P., Otten, R., & Creemers, D. H. M. (2022) · Journal of Autism and Developmental Disorders · doi:10.1007/s10803-021-04927-8 · Cited by 6
Self-citationHall, G. J., Putzeys, S., Kratochwill, T. R., & Levin, J. R. (2024) · Educational Psychology Review · doi:10.1007/s10648-024-09962-2 · Cited by 5
“Randomizing the sequences is more typical and credible in ATDs (see Onghena & Edgington, 1994, 2005) and in within-case replicated AB or AB k designs (Levin et al., 2012).”
de Roos, C., Offermans, J. E., Bouwmeester, S., Lindauer, R., & Scheper, F. Y. (2025) · European Journal of Psychotraumatology · doi:10.1080/20008066.2024.2447654 · Cited by 5
Robertz, A., Törnhage, C.-J., Nilsson, S., Nyman, V., & Kantzer, A.-K. (2024) · Complementary Therapies in Clinical Practice · doi:10.1016/j.ctcp.2024.101909 · Cited by 5
Analyzing data in single-case experimental designs: Objectives and available software options
Manolov, R., & Rochat, L. (2024) · Journal of Behavioral and Cognitive Therapy · doi:10.1016/j.jbct.2024.100511 · Cited by 5
Lourenço, M. G., Fuller, T., Ranson, S., Vlaeyen, J., & Cima, R. (2022) · Ear and Hearing · doi:10.1097/aud.0000000000001261 · Cited by 5
Meta-Analysis of Single-Case Data: A Monte Carlo Investigation of a Three Level Model
Owens, C. M. (2011) · Digital Commons - University of South Florida (University of South Florida) · Cited by 5
Norman‐Nott, N., Wilks, C. R., Hesam‐Shariati, N., Schroeder, J., Suh, J., Czerwinski, M. P., & Gustin, S. M. (2021) · BMJ Open · doi:10.1136/bmjopen-2020-041745 · Cited by 5
Manolov, R., Onghena, P., & Noortgate, W. V. D. (2022) · Evidence-Based Communication Assessment and Intervention · doi:10.1080/17489539.2022.2040164 · Cited by 5
“The sequence of conditions is predetermined (Kratochwill & Levin, 1980) and it can be counterbalanced or determined at random, under several possible randomization schemes, such as the completely randomized design or the randomized block design (Onghena & Edgington, 1994, 2005).”
BackgroundSelf-citationAssessing Consistency in Single-Case Alternation Designs
Manolov, R., Tanious, R., De, T. K., & Onghena, P. (2020) · Behavior Modification · doi:10.1177/0145445520923990 · Cited by 5
“Alternation designs are SCEDS that are characterized by the rapid alternation of the treatment levels, in contrast to phase designs that are characterized by a larger number of consecutive measurement occasions under the same treatment level (Onghena & Edgington, 2005).”
BackgroundSelf-citationManolov, R., & Onghena, P. (2023) · Behavior Research Methods · doi:10.3758/s13428-023-02230-1 · Cited by 5
Self-citationHecker, L., King, S., Stapert, S. Z., Geusgens, C. A. V., den Hollander, M., Fleischeuer, B., & Heugten, C. M. V. (2024) · Journal of Head Trauma Rehabilitation · doi:10.1097/htr.0000000000001023 · Cited by 6
Janssen, H., van den Berg, K. C., Keijsers, G. P. J., Paulik, G., Newman‐Taylor, K., Taylor, C. D. J., Steel, C., & Marcelis, M. C. (2025) · Schizophrenia Bulletin · doi:10.1093/schbul/sbaf033 · Cited by 4
“51 We used this randomization test procedure to compare the imagery and AVHs measures for phases A 1 and B, B and A 2 , and A 1 and A 2 .”
Effects of asymmetric loading on lateral spinal curvature in young adults with scoliosis
Li, S. S., & Chow, D. H. K. (2018) · Prosthetics and Orthotics International · doi:10.1177/0309364618757784 · Cited by 4
Moeyaert, M., & Fingerhut, J. E. (2022) · Harvard data science review · doi:10.1162/99608f92.3574f1dc · Cited by 4
“Alternative AD methods involve vote counting (Michael Borenstein et al., 2009) or combining p values (Michael Borenstein et al., 2009)(Onghena & Edgington, 2005).”
van Goethem, A. A. J., Mulders, D., de Jong, J. R., Arntz, A. R., & Egger, J. I. M. (2015) · Research Publications (Maastricht University) · Cited by 4
Atzeni, T. (2012) · Applied Neuropsychology Adult · doi:10.1080/09084282.2011.643957 · Cited by 3
“…categorized either as a nomothetic approach (e.g., group studies) or an idiographic one (e.g., singlecase experiment), where the test of a hypothesis involves identifying the effect of one or several manipulated independent variables on a dependent variable (Juhel, 2008; Onghena & Edgington, 2005).”
BackgroundMethodIntervention research in anorexia nervosa – a plea for single case experimental designs
Melles, H., Lemmens, L. H. J. M., & Jansen, A. T. M. (2025) · Eating Disorders · doi:10.1080/10640266.2025.2471218 · Cited by 3
“Changes in these variables that occur during phase B can then be causally linked to the intervention being studied, while maximizing internal and external validity (Kazdin, 2019, 2021; Onghena & Edgington, 2005; Smith, 2012).”
InfluentialA robot intervention for adults with ADHD and insomnia–A mixed-method proof-of-concept study
Støre, S. J., Tillfors, M., Angelhoff, C., & Norell‐Clarke, A. (2023) · PLoS ONE · doi:10.1371/journal.pone.0290984 · Cited by 4
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Self-citationType I error rates and power of two randomization test procedures for the changing criterion design
Manolov, R., & Tanious, R. (2023) · Behavior Research Methods · doi:10.3758/s13428-023-02303-1 · Cited by 2
“…compare the results of the current study with the results from a simulation study on a randomization test applied to alternating treatments design with block randomization (also called randomized block designs) (Onghena & Edgington, 2005), given that the randomization procedure is similar to BAC.”
ResultIngeman, K., Frydendal, D. H., Frostholm, L., Bjerre-Nielsen, E., Wellnitz, K. B., Onghena, P., Wright, K. D., & Rask, C. U. (2025) · JMIR Formative Research · doi:10.2196/65396 · Cited by 1
“The P values calculated for each participant were combined using the Edgington additive method [59].”
Self-citationIshita, S. Z., Kaliappan, S., Rashik, M., Epstein, D. A., & Karkar, R. (2026) · CHI Conference on Human Factors in Computing Systems · doi:10.1145/3772318.3791551 · Cited by 2
“Conversely, the system is instructed to suggest randomized designs only when the independent variable has a more immediate, short-lived effect [42, 74], ensuring the chosen experimental structure can validly detect a relationship.”
Wiertz, C. M. H., van Meulenbroek, T., Lamper, C., Hemmen, B., Sep, S. J. S., Huijnen, I. P. J., Goossens, M. E. J. B., Burgers, J. S., & Verbunt, J. (2024) · JMIR Research Protocols · doi:10.2196/63951 · Cited by 2
Peeters, N., van Passel, B., Hendriks, G., Becker, E. S., & Krans, J. (2024) · Psychiatry Research Case Reports · doi:10.1016/j.psycr.2024.100241 · Cited by 2
Janssen, E. P. J., Spauwen, P. J. J., Rijnen, S. J. M., & Ponds, R. (2025) · Neuropsychological Rehabilitation · doi:10.1080/09602011.2024.2444999 · Cited by 2
“For each participant, a SCED was used in which baseline phase (A) length of either 2, 3 or 4 weeks was randomized across participants (Onghena & Edgington, 2005; Smith, 2012) using start-point randomization (Michiels & Onghena, 2019).”
Lourenco, M. P. C. G., Cima, R. F. F., & Vlaeyen, J. W. S. (2021) · Progress in brain research · doi:10.1016/bs.pbr.2021.04.009 · Cited by 2
The effects of a self-regulated writing Intervention on English learners' academic writing skills
Akhmedjanova, D. R. (2020) · Scholars Archive - University at Albany (University at Albany, State University of New York) · doi:10.54014/ctf1-vh9s · Cited by 2
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“A multiple baseline design is considered an experimental single-case designs and allows testing whether changes in parenting behavior and parental stress are the result of the intervention and not of time, and whether the change is meaningful (Onghena & Edgington, 2005; Tanious & Onghena, 2019).”
Self-citationOba, T., Takano, K., Sugawara, D., & Kimura, K. (2025) · JMIR Formative Research · doi:10.2196/69556 · Cited by 1
“Randomization tests were conducted on each participant and group of participants [46].”
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Annotated Bibliography of Single Subject Studies
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Dialectische gedragstherapie voor de behandeling van BPS
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“Missing data points are displayed as gaps in the time series, allowing us to interpret potential patterns of missingness and to examine whether they may relate to the dependent variables or to contextual factors [56].”
Petrevska, M., Wright, F. V., Khan, A., Sert, S., Ferreira, I. D., Munce, S., Fehlings, D. L., & Biddiss, E. A. (2026) · Journal of NeuroEngineering and Rehabilitation · doi:10.1186/s12984-025-01819-1
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Self-citationGertler, P., Emery, H., Doubleday, J., Tate, R. L., Filipčíková, M., Honan, C. A., Wong, D. K., Carrier, S. L., Ownsworth, T., Douglas, J. M., et al. (2026) · Neuropsychological Rehabilitation · doi:10.1080/09602011.2026.2682140
Sharaa, H. A., Bartels, S. L., Onghena, P., Taygar, A. S., Engman, L., Flink, I. K., Petersson, S., Boersma, K., McCracken, L. M., Simons, L. E., et al. (2026) · Digital Health · doi:10.1177/20552076261467865 · Cited by 1
“56 Specifically, we summed individual directional p-values across participants for each diary item, which we then compared to a reference distribution of sums generated under the null hypothesis with the p-values following a uniform [0,1] distribution.”
Self-citationTanious, R., Madden, V. J., Sharma, S., Cañeiro, J. P., Lee, J. K., Wicksell, R. K., Parker, R., & Vlaeyen, J. W. S. (2026) · Pain · doi:10.1097/j.pain.0000000000004063
Metadata
- Authors
- Onghena, P., & Edgington, E. S.
- Affiliations
- KU Leuven (BE)
- University of Calgary (CA)
- Corresponding author
- Onghena, Patrick
- ORCID
- Onghena, Patrick
- Venue
- The Clinical Journal of Pain
- Published
- 2005-01
- Volume
- 21
- Issue
- 1
- Pages
- 56-68
- ISSN
- 0749-8047 (ISSN-L)
- OpenAlex
- W2117635631
- Cited by
- 188
- References
- 113
- Citations by year
- 2026: 6 · 2025: 10 · 2024: 14 · 2023: 10 · 2022: 16 · 2021: 13 · 2020: 13 · 2019: 17 · 2018: 7 · 2017: 12 · 2016: 8 · 2015: 9 · 2014: 5 · 2013: 6 · 2012: 10
- FWCI
- 0.31
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Clinical Journal of Pain (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Health Professions › Physical Therapy, Sports Therapy and Rehabilitation › Musculoskeletal pain and rehabilitation
- Health Sciences › Medicine › Anesthesiology and Pain Medicine › Pain Management and Opioid Use
- Keywords
- single-case experimental design, pain management, personalized treatment, replication strategies, permutation tests, combining p-values, meta-analysis, internal validity, statistical conclusion validity, construct validity, generalizability, reliability and validity, effect size, power analysis
- MeSH terms
- Data Interpretation, Statistical, Humans, Research Design, Reproducibility of Results, Randomized Controlled Trials as Topic, Pain Management
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