@misc{10481/97674,
year = {2024},
month = {11},
url = {https://hdl.handle.net/10481/97674},
abstract = {The HEALTHYBACK trial is based on a multimodal
intervention to determine the effectiveness of a supervised
physical exercise, mindfulness, behaviour change and
pain neuroscience education programme on several health
variables in individuals with chronic primary low back pain
(CPLBP). The study will be a randomised controlled trial
among 70 individuals diagnosed with CPLBP (aged 18–65
years). The intervention will be conducted in person within
a hospital setting for 16 weeks and comprises a first phase
(16 sessions supervised physical exercise (2 days/week,
45 min/session), mindfulness (1 day/week, 2.5 hours/
session), behaviour change (daily/24 hours via a wrist-worn
activity prompting device) and pain neuroscience
education (1 day/biweekly, 2 hours/session)) and a
second phase (16 sessions functional full-body
muscle
strengthening exercise, 3 days/week, 50 min/session). The
primary outcomes will include perceived acute pain, pain
pressure threshold, conditioned pain modulation, temporal
summation of pain and disability due to pain. Secondary
measures will include physical fitness, body composition,
gait parameters, device-measured
physical activity and
sedentary behaviour, haematological profile, self-reported
sedentary behaviour, quality of life, pain catastrophising,
mental health, sleep duration and quality, and symptoms
related to central sensitisation. The groups will undergo
pretest (before the intervention), post-test
(after each phase
of the intervention) and retest (at a 6-week
detraining
period after the intervention) measurements. The results
will determine the effectiveness of multidimensional
interventions on several health parameters in individuals
with CPLBP. They will provide knowledge for pain
management and functioning in affected individuals, which
might diminish the need for primary healthcare services.
Trial registration number: NCT06114264.},
organization = {Instituto de Salud Carlos III through the
fellowships CP20/00178 and PI22/01791, co-funded
by the European Social Fund},
organization = {Instituto de Salud Carlos III through the PFIS contract
(FI23/00034), co-funded
by the European Social Fund+},
organization = {'Margarita Salas' postdoctoral grant UCOR01MS, convened by the University
of Córdoba (UCO) and funded by the Ministry of the University of Spain and the
European Union-Next
Generation EU},
publisher = {BMJ Publishing Group},
title = {Multimodal intervention based on physical exercise, mindfulness, behaviour change and education to improve pain and health in patients with chronic primary low back pain: a study protocol of the HEALTHYBACK randomised controlled trial},
doi = {10.1136/bmjsem-2024-002188},
author = {Tsiarleston, Gavriella and López-Fernández, Maria Dolores and Pavón Muñoz, Rodrigo and Aguilera García, Iván and López Corchón, María and Delgado Fernández, Manuel and Castellote Caballero, Yolanda and Donoso, Belén and Mesa Ruiz, Antonio Manuel and Pozuelo Calvo, Rocio and Ríos Ortiz, Ángela María and Álvarez Corral, Gemma and Marín Jiménez, Nuria and Martínez García, Dario and Chirosa Ríos, Ignacio Jesús and Segura Jiménez, Víctor},
}