Pain state-dependent multimodal assessment in non-specific low back pain: a pseudorandomized study design with implementation insights
- 1Integrative Spinal Research, Department of Chiropractic Medicine, Balgrist University Hospital, University of Zurich, Zurich, Switzerland; Neuroscience Center Z
Abstract
BackgroundFluctuations in pain intensity are intrinsic to non-specific chronic low back pain (nsCLBP). Nevertheless, pain fluctuations have rarely been considered when investigating pathophysiological mechanisms. Therefore, a novel study protocol was developed and implemented to systematically assess the impact of fluctuating pain states on pain-related measures.
MethodsThe final study cohort consisted of 45 nsCLBP patients and 47 age- and sex-matched healthy controls (HCs). Patients participated in three visits, conducted during different pain states (i.e. clinically relevant pain, low-intensity clinical pain / pain-free, clinically irrelevant pain induced using a Qutenza 8% capsaicin patch). Pain fluctuations were monitored through online assessments every four days and guided the pseudorandomized visit scheduling. HCs participated in a single visit. Each study visit comprised a multimodal battery of pain-related measures.
Results93.33% of patients completed all three visit types in a pseudorandomized order ({chi}{superscript 2}=1.50, p=0.826). Visit scheduling was possible due to the high self-report adherence (median=93.48%), unrelated to self-report burden ({rho}=-0.097, p=0.53). Study visits were conducted during different pain states, as indicated by: i) the significantly higher low back pain intensity in the clinically relevant pain visit (mean[SD]: 3.98[0.90]), compared to the low-intensity clinical pain (1.03[0.86]) and clinically irrelevant pain (1.13[0.82]) visits (p-values<0.001), as well as by ii) the successful induction of a moderate-to-high clinically irrelevant pain across assessments.
ConclusionDespite scheduling complexity and pain state transition uncertainty, a pain state-dependent pseudorandomized study design is feasible and could improve the understanding of nsCLBP mechanisms.
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BibTeX
@misc{barrientos2026pain,
title = {{Pain state-dependent multimodal assessment in non-specific low back pain: a pseudorandomized study design with implementation insights}},
author = {B. Chozas Barrientos and M. Hau and L. Sirucek and A. Langenfeld and M. Wehrli and B. Wirth and N. Zoelch and J. Devan and S. Dudli and P. Schweinhardt},
howpublished = {medRxiv},
year = {2026},
month = aug,
doi = {10.64898/2026.08.26.26359760},
url = {https://www.medrxiv.org/content/10.64898/2026.08.26.26359760v1},
note = {CC BY},
}
RIS
TY - UNPB
TI - Pain state-dependent multimodal assessment in non-specific low back pain: a pseudorandomized study design with implementation insights
AU - B. Chozas Barrientos
AU - M. Hau
AU - L. Sirucek
AU - A. Langenfeld
AU - M. Wehrli
AU - B. Wirth
AU - N. Zoelch
AU - J. Devan
AU - S. Dudli
AU - P. Schweinhardt
PY - 2026
DA - 2026/08/26
PB - medRxiv
DO - 10.64898/2026.08.26.26359760
UR - https://www.medrxiv.org/content/10.64898/2026.08.26.26359760v1
AB - BackgroundFluctuations in pain intensity are intrinsic to non-specific chronic low back pain (nsCLBP). Nevertheless, pain fluctuations have rarely been considered when investigating pathophysiological mechanisms. Therefore, a novel study protocol was developed and implemented to systematically assess the impact of fluctuating pain states on pain-related measures. MethodsThe final study cohort consisted of 45 nsCLBP patients and 47 age- and sex-matched healthy controls (HCs). Patients participated in three visits, conducted during different pain states (i.e. clinically relevant pain, low-intensity clinical pain / pain-free, clinically irrelevant pain induced using a Qutenza 8% capsaicin patch). Pain fluctuations were monitored through online assessments every four days and guided the pseudorandomized visit scheduling. HCs participated in a single visit. Each study visit comprised a multimodal battery of pain-related measures. Results93.33% of patients completed all three visit types in a pseudorandomized order ({chi}{superscript 2}=1.50, p=0.826). Visit scheduling was possible due to the high self-report adherence (median=93.48%), unrelated to self-report burden ({rho}=-0.097, p=0.53). Study visits were conducted during different pain states, as indicated by: i) the significantly higher low back pain intensity in the clinically relevant pain visit (mean[SD]: 3.98[0.90]), compared to the low-intensity clinical pain (1.03[0.86]) and clinically irrelevant pain (1.13[0.82]) visits (p-values<0.001), as well as by ii) the successful induction of a moderate-to-high clinically irrelevant pain across assessments. ConclusionDespite scheduling complexity and pain state transition uncertainty, a pain state-dependent pseudorandomized study design is feasible and could improve the understanding of nsCLBP mechanisms.
ER -