Evidence map›Paper›PMID 39610994›Full record

ArticleBMJ open sport & exercise medicine2024

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.

Gavriella Tsiarleston, María Dolores López-Fernández, Rodrigo Pavón-Muñoz, Iván Aguilera-García, María López-Corchón, Manuel Delgado-Fernández, María Yolanda Castellote-Caballero, Belén Donoso, Antonio Manuel Mesa-Ruiz, Rocío Pozuelo-Calvo and 6 more

Erratum issued Registry-linked trialAbstract read
In one paragraph

Article in BMJ open sport & exercise medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT06114264 (Multimodal Intervention to Improve Pain and Health in Patients With Non-specific Chronic Low Back Pain), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06114264 nacompletednot on this map

Multimodal Intervention to Improve Pain and Health in Patients With Non-specific Chronic Low Back Pain: the HEALTHY BACK Project

TypeinterventionalSponsorIBS GranadaRan2023 to 2025Enrolled70ConditionsPain, Chronic, Neurologic Manifestations, Back Pain, Low Back PainArmsMultimodal + Resistance Programs, Control group
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors.

Gavriella TsiarlestonInstituto de Investigación Biosanitaria ibs.GRANADA, Granada, Spain.
María Dolores López-FernándezInstituto de Investigación Biosanitaria ibs.GRANADA, Granada, Spain.ORCID 0000-0002-2383-8362
Rodrigo Pavón-MuñozPhysical Activity for Health Promotion (PA-HELP) Research Group, Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Granada, Spain.
Iván Aguilera-GarcíaFaculty of Health Sciences, University of Granada, Granada, Spain.
María López-CorchónBrain and Pain Lab, Department of Clinical Psychology and Psychobiology, Faculty of Psychology, University of Santiago de Compostela, Santiago de Compostela, Spain.
Manuel Delgado-FernándezPhysical Activity for Health Promotion (PA-HELP) Research Group, Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Granada, Spain.
María Yolanda Castellote-CaballeroDepartment of Health Sciences, University of Jaén, Jaén, Spain.
Belén DonosoDepartment of Psychology, Faculty of Education Sciences and Psychology, University of Cordoba, Cordoba, Spain.
Antonio Manuel Mesa-RuizInstituto de Investigación Biosanitaria ibs.GRANADA, Granada, Spain.
Rocío Pozuelo-CalvoInstituto de Investigación Biosanitaria ibs.GRANADA, Granada, Spain.
Ángela María Ríos-OrtizUGC Medicina Física y Rehabilitación, Hospital Universitario Virgen de las Nieves, Granada, Spain.
Gemma Álvarez-CorralInstituto de Investigación Biosanitaria ibs.GRANADA, Granada, Spain.
Nuria Marín-JiménezGALENO Research Group, Department of Physical Education, Faculty of Education Sciences, University of Cádiz, Cádiz, Spain.
Dario Martinez-GarciaDepartment of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Granada, Spain.
Ignacio Jesús Chirosa RíosDepartment of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Granada, Spain.
Víctor Segura-JiménezInstituto de Investigación Biosanitaria ibs.GRANADA, Granada, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

ExerciseExercise rehabilitationGait analysisLumbar spinePhysical activity

Identifiers

PMID39610994
PMCPMC11603803

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.