Boosting open-label placebo effects in acute induced pain in healthy adults (BOLPAP-study): study protocol of a randomized controlled trial
IntroductionPain is a highly prevalent symptom in the hospital setting, but treatment options remain limited. Harnessing the placebo effect in an ethical manner could provide a new possibility to reduce pain in clinical practice. So called open-label placebos (OLP) have been shown to elicit signific...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2024-02-01
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| Series: | Frontiers in Medicine |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fmed.2024.1238878/full |
| _version_ | 1797310517378809856 |
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| author | Matthijs de Leeuw Mirjam Laager Jens Gaab Wilhelm Ruppen Tobias Schneider |
| author_facet | Matthijs de Leeuw Mirjam Laager Jens Gaab Wilhelm Ruppen Tobias Schneider |
| author_sort | Matthijs de Leeuw |
| collection | DOAJ |
| description | IntroductionPain is a highly prevalent symptom in the hospital setting, but treatment options remain limited. Harnessing the placebo effect in an ethical manner could provide a new possibility to reduce pain in clinical practice. So called open-label placebos (OLP) have been shown to elicit significant effects in reducing acute pain. But, before implementation, more knowledge concerning the properties of OLPs is needed. This study aims to assess the duration of analgesic effects from OLP and to determine the possibility of boosting such effects.Methods and analysisThis is the protocol of an ongoing (first patient enrolled in March 2023) single-site randomized trial investigating OLPs in two parts (i.e., substudies). In both parts, pain will be induced in healthy adults using an intradermal electrical stimulation model. Participants in Part 1 will have two study visits: An interventional visit with one OLP injection accompanied by an evidence-based treatment rationale and a control visit with no treatment. For Part 2, participants will be randomized into three groups: (1) A fixed-time “Booster” group including one single repetition of the OLP injection at a fixed time point, (2) an on-demand “Booster” group including one single repetition of the OLP injection on-demand, and (3) a control group who will receive just one OLP injection. Differences in pain ratings over time (using the Numeric Rating Scale) will be analyzed with several two-sample t-tests. The time point for a fixed-time “Booster” in Part 2 will be derived from Part 1 with additional statistical tools such as a broken-stick mixed-effect model.DiscussionThis study aims to further characterize the analgesic effects of OLPs. In doing so, it will provide valuable information needed for later implementation of OLPs in clinical practice, where they could play a role in multimodal analgesic concepts.Ethics and disseminationThe “Ethikkommission Nordwest- und Zentralschweiz” (BASEC 2023-00296) approved the study protocol. Results of the analysis will be submitted for publication in a peer-reviewed journal.Clinical Trial RegistrationThis study is registered at ClinicalTrials.gov (NCT05819476) and is listed in the Swiss National Registry at kofam.ch (SNCTP000005470). |
| first_indexed | 2024-03-08T01:45:08Z |
| format | Article |
| id | doaj.art-50c75da3951c48379da103580b9de67e |
| institution | Directory Open Access Journal |
| issn | 2296-858X |
| language | English |
| last_indexed | 2024-03-08T01:45:08Z |
| publishDate | 2024-02-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Medicine |
| spelling | doaj.art-50c75da3951c48379da103580b9de67e2024-02-14T13:02:30ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2024-02-011110.3389/fmed.2024.12388781238878Boosting open-label placebo effects in acute induced pain in healthy adults (BOLPAP-study): study protocol of a randomized controlled trialMatthijs de Leeuw0Mirjam Laager1Jens Gaab2Wilhelm Ruppen3Tobias Schneider4Pain Unit, Clinic for Anesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel, Basel, SwitzerlandDepartment of Clinical Research, University of Basel, Basel, SwitzerlandDivision of Clinical Psychology and Psychotherapy, Faculty of Psychology, University of Basel, Basel, SwitzerlandPain Unit, Clinic for Anesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel, Basel, SwitzerlandPain Unit, Clinic for Anesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel, Basel, SwitzerlandIntroductionPain is a highly prevalent symptom in the hospital setting, but treatment options remain limited. Harnessing the placebo effect in an ethical manner could provide a new possibility to reduce pain in clinical practice. So called open-label placebos (OLP) have been shown to elicit significant effects in reducing acute pain. But, before implementation, more knowledge concerning the properties of OLPs is needed. This study aims to assess the duration of analgesic effects from OLP and to determine the possibility of boosting such effects.Methods and analysisThis is the protocol of an ongoing (first patient enrolled in March 2023) single-site randomized trial investigating OLPs in two parts (i.e., substudies). In both parts, pain will be induced in healthy adults using an intradermal electrical stimulation model. Participants in Part 1 will have two study visits: An interventional visit with one OLP injection accompanied by an evidence-based treatment rationale and a control visit with no treatment. For Part 2, participants will be randomized into three groups: (1) A fixed-time “Booster” group including one single repetition of the OLP injection at a fixed time point, (2) an on-demand “Booster” group including one single repetition of the OLP injection on-demand, and (3) a control group who will receive just one OLP injection. Differences in pain ratings over time (using the Numeric Rating Scale) will be analyzed with several two-sample t-tests. The time point for a fixed-time “Booster” in Part 2 will be derived from Part 1 with additional statistical tools such as a broken-stick mixed-effect model.DiscussionThis study aims to further characterize the analgesic effects of OLPs. In doing so, it will provide valuable information needed for later implementation of OLPs in clinical practice, where they could play a role in multimodal analgesic concepts.Ethics and disseminationThe “Ethikkommission Nordwest- und Zentralschweiz” (BASEC 2023-00296) approved the study protocol. Results of the analysis will be submitted for publication in a peer-reviewed journal.Clinical Trial RegistrationThis study is registered at ClinicalTrials.gov (NCT05819476) and is listed in the Swiss National Registry at kofam.ch (SNCTP000005470).https://www.frontiersin.org/articles/10.3389/fmed.2024.1238878/fullopen-label placeboboosterplacebo analgesiaacute painelectrically-evoked painhyperalgesia |
| spellingShingle | Matthijs de Leeuw Mirjam Laager Jens Gaab Wilhelm Ruppen Tobias Schneider Boosting open-label placebo effects in acute induced pain in healthy adults (BOLPAP-study): study protocol of a randomized controlled trial Frontiers in Medicine open-label placebo booster placebo analgesia acute pain electrically-evoked pain hyperalgesia |
| title | Boosting open-label placebo effects in acute induced pain in healthy adults (BOLPAP-study): study protocol of a randomized controlled trial |
| title_full | Boosting open-label placebo effects in acute induced pain in healthy adults (BOLPAP-study): study protocol of a randomized controlled trial |
| title_fullStr | Boosting open-label placebo effects in acute induced pain in healthy adults (BOLPAP-study): study protocol of a randomized controlled trial |
| title_full_unstemmed | Boosting open-label placebo effects in acute induced pain in healthy adults (BOLPAP-study): study protocol of a randomized controlled trial |
| title_short | Boosting open-label placebo effects in acute induced pain in healthy adults (BOLPAP-study): study protocol of a randomized controlled trial |
| title_sort | boosting open label placebo effects in acute induced pain in healthy adults bolpap study study protocol of a randomized controlled trial |
| topic | open-label placebo booster placebo analgesia acute pain electrically-evoked pain hyperalgesia |
| url | https://www.frontiersin.org/articles/10.3389/fmed.2024.1238878/full |
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