Background & Aims
Post-dural-puncture headache (PDPH) affects approximately 10% of patients after lumbar puncture (LP) [1]. Physicians usually discuss the risk of PDPH with patients before obtaining consent for the procedure. Prior research suggested that not mentioning the risk beforehand could substantially reduce headaches after LP, implicating that they are subject to strong nocebo effects [2]. However, withholding information conflicts with patient autonomy principles. Experimental studies propose communication techniques like positive framing, recency and primacy effects, emphasizing coping strategies, informing about nocebo effects, and empathetic behavior as effective mitigators of nocebo effects without altering risk disclosure content [3]. This study tests whether an optimized risk disclosure protocol employing these techniques can reduce post-LP headaches compared to a standard disclosure among inpatients at the neurologic department of the University Hospital Essen.
Methods
In this preregistered, prospective, randomized, controlled clinical trial conducted at the University Hospital Essen, a total of n = 80 patients with an indication for a diagnostic lumbar puncture are randomly assigned to either the experimental group (EXP) or the treatment-as-usual group (TAU). Procedural information and risk disclosure for LP are presented orally by the study physician according to different protocols: for EXP, optimized communication strategies aimed to reduce nocebo effects are applied, while TAU receives standard delivery of contents. LP is performed by the same study physician. Data is collected through online surveys and interviews conducted by personnel blinded to group allocation. The primary outcome is the degree of impairment by headache post lumbar puncture, measured on a numeric rating scale from 0-10 at 3h, 24h, and 72h after the procedure.
Results
Data collection commenced in December 2023 and is anticipated to conclude in May 2024. The preliminary findings will be presented at the conference.
Conclusions
This study investigates the cumulative impact of several communication strategies designed to reduce headache after lumbar puncture as an initial proof-of-concept. Our objective is to apply knowledge derived from preclinical research on expectation effects and their modifiers, testing the efficacy of easily implementable techniques to diminish the nocebo component of procedure-related unwanted effects in a naturalistic clinical setting.
References
1.Nath, S., et al., Atraumatic versus conventional lumbar puncture needles: a systematic review and meta-analysis. Lancet, 2018. 391(10126): p. 1197-1204.
2.Daniels, A.M. and R. Sallie, Headache, lumbar puncture, and expectation. Lancet, 1981. 1(8227): p. 1003.
3.Manai, M., et al., How to prevent, minimize, or extinguish nocebo effects in pain: a narrative review on mechanisms, predictors, and interventions. Pain Rep, 2019. 4(3): p. e699.
Presenting Author
Livia Asan
Poster Authors
Livia Asan
MD
University Hospital Essen, Department of Neurology
Lead Author
Julian Kleine-Borgmann
MD
Lead Author
Dagny Holle-Lee
MD
Lead Author
Sven Benson
Prof. Dr.
Lead Author
Christoph Kleinschnitz
MD
Lead Author
Johanna Sophie Gronen
Lead Author
Ulrike Bingel
University Duisburg-Essen, University Hospital
Lead Author
Topics
- Placebo