Clinical trial NCT04115670: Influence of Health Determinants on Physical Exercise Therapy With a Neurocognitive Focus on Chronic Low Back Pain
Official title: Influence of Health Determinants and Therapeutic Alliance on the Effectiveness of a Pain Neuroscience Education Combined With Motor Control Training With Neurocognitive Focus on Chronic Lumbar Pain in a Population of Professional Caregivers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Low-back Pain
Lead sponsor: Fundació Universitària del Bages
Sponsor class: OTHER
First posted: 2019-10-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Protocols in which pain neuroscience education is combined with physical exercise have shown recently greater effectiveness in the treatment of low back pain in comparison to protocols based only on one of the two approaches. The professional caregiver has a high incidence of low back pain related to the specific aspects of this collection with the low physical condition, the typical tasks performed and other psychosocial aspects. Individual characteristics of these caregivers may condition the effectiveness of the therapy as well as demographic aspects or the alliance between patient and physiotherapist. The aim of this study is to determine the influence of certain health determinants on the effectiveness of a therapy that combines pain neuroscience education and motor control training from a neurocognitive perspective on chronic low back pain in a population of professional caregivers in Bages, analyzing the reduction of low back pain, the improvement of functionality, the reduction of muscle movement and the improvement of muscle coordination.

It will be a quasi-experimental pre-post design, prospective, with a control group, lasting 3 months. The intervention will be performed using a sample of professional caregivers, and the data will be collected before the intervention, at the end of the intervention, and 3-6 months after the intervention. Pain, functionality, conducts of fear/avoidance, and muscular coordination will be analyzed


Eligibility criteria: Inclusion Criteria:

* Of legal age
* Participants who present lumbar or lumbosacral pain all the time for more than 1 year
* Score of 6 on the Visual Analogical Scale
* Have been at work (same position) longer than 1 year

Exclusion Criteria:

* Other alterations and diseases of the musculoskeletal system that may interfere with the results of the intervention.
* Pregnancy during the study time
* Older than 65 years old

Primary outcomes:
measure: Change from Baseline in Pain perceived at 3 months: Visual Analogue Scale
timeFrame: Baseline and 3 months
measure: Change from Baseline in Pain perceived at 6 months: Visual Analogue Scale
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change from Baseline in Fear and avoidance of movement at 3 months
timeFrame: Baseline and 3 months
measure: Change from Baseline in Pain disability at 3 months: Oswestry Disability Index
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Manresa
country: Spain
facility: Universitat de Vic-Universitat de Catalunya (UVic-UCC)
state: Barcelona
Study officials:
affiliation: University of Vic - Central University of Catalonia
name: Júlia Jubany, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Radebold A, Cholewicki J, Panjabi MM, Patel TC. Muscle response pattern to sudden trunk loading in healthy individuals and in patients with chronic low back pain. Spine (Phila Pa 1976). 2000 Apr 15;25(8):947-54. doi: 10.1097/00007632-200004150-00009.
citation: Kamper SJ, Apeldoorn AT, Chiarotto A, Smeets RJ, Ostelo RW, Guzman J, van Tulder MW. Multidisciplinary biopsychosocial rehabilitation for chronic low back pain. Cochrane Database Syst Rev. 2014 Sep 2;2014(9):CD000963. doi: 10.1002/14651858.CD000963.pub3.
citation: Malfliet A, Kregel J, Meeus M, Cagnie B, Roussel N, Dolphens M, Danneels L, Nijs J. Applying contemporary neuroscience in exercise interventions for chronic spinal pain: treatment protocol. Braz J Phys Ther. 2017 Sep-Oct;21(5):378-387. doi: 10.1016/j.bjpt.2017.06.019. Epub 2017 Jul 8.
citation: Yang H, Haldeman S, Lu ML, Baker D. Low Back Pain Prevalence and Related Workplace Psychosocial Risk Factors: A Study Using Data From the 2010 National Health Interview Survey. J Manipulative Physiol Ther. 2016 Sep;39(7):459-472. doi: 10.1016/j.jmpt.2016.07.004. Epub 2016 Aug 25.