Influence of Health Determinants on Physical Exercise Therapy With a Neurocognitive Focus on Chronic Low Back Pain

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

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

Study Overview

• Status: Unknown
• Conditions: Chronic Low-back Pain
• Intervention / Treatment: Behavioral: Group of educational intervention on the neurophysiology of pain and physical exercises; Behavioral: Control group

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olga Borao, PhD; Phone Number: 363 0034 938774179; Email: oborao@umanresa.cat
• Study Contact Backup: Name: Júlia Jubany, PhD; Phone Number: 370 0034 938774179; Email: jjubany@umanresa.cat

Study Locations

• Spain
  • Barcelona
    • Manresa, Barcelona, Spain, 08242
      • Universitat de Vic-Universitat de Catalunya (UVic-UCC)
      • Contact: Olga Borao, PhD; Phone Number: 363 0034 938774179; Email: oborao@umanresa.cat
      • Contact: Júlia Jubany, PhD; Phone Number: 370 0034 938774179; Email: jjubany@umanresa.cat
      • Sub-Investigator: Mireia Campoy, University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: specific intervention (experimental); Specific intervention (experimental). The intervention group will carry out 3 sessions of specific pain education + 15 sessions of physical training.	Behavioral: Group of educational intervention on the neurophysiology of pain and physical exercises; The physiotherapist of the institution will execute the intervention on the group: 3 first pedagogical sessions on the neurophysiology of pain, distributed: 1 group session, 1 individual session at home, 1 in a personal interview format. These 3 sessions will last 2 weeks to be completed.; Afterward, the protocol of physical exercise training will begin, supervised by the same physiotherapist who carried out the three initial sessions. There will be 15 sessions of specific and individualized physical exercise, in small groups of maximum 5 people. The duration of this part will be 10 weeks, so that from week 1 to 5 is 2 times per week, and from week 6 to 10 just 1 time per week.
Active Comparator: control group (no intervention); NO intervention	Behavioral: Control group; The control group will follow its normal course of activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Pain perceived at 3 months: Visual Analogue Scale	Analisis of pain, using the Visual Analogue Scale, that measure from 0 (no pain) to 10 (excruciating pain)	Baseline and 3 months
Change from Baseline in Pain perceived at 6 months: Visual Analogue Scale	Analisis of pain, using the Visual Analogue Scale, that measure from 0 (no pain) to 10 (excruciating pain)	Baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Fear and avoidance of movement at 3 months	Tampa Scale of Kinesophobia, a scale with 11 items, the rating ranges from 11 points to 44 points. A high value indicates that there is a high degree of fear of movement.	Baseline and 3 months
Change from Baseline in Pain disability at 3 months: Oswestry Disability Index	Oswestry Disability Index, This scale consists of 10 questions, each of them with answers graduated from 0 (no relevant) to 5 (very relevant), from which the % of disability of the individual is obtained from the formula: Total points of the answers / 50 *100= % disabled	Baseline and 3 months

Collaborators and Investigators

• Sponsor: Fundació Universitària del Bages
• Investigators: Principal Investigator: Júlia Jubany, PhD, Universitat de Vic-Universitat Central de Catalunya

Publications and helpful links

General Publications

• Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, Woolf A, Vos T, Buchbinder R. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012 Jun;64(6):2028-37. doi: 10.1002/art.34347. Epub 2012 Jan 9.
• 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;(9):CD000963. doi: 10.1002/14651858.CD000963.pub3.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 2, 2019
• Primary Completion (Anticipated): April 30, 2020
• Study Completion (Anticipated): December 20, 2020

Study Registration Dates

• First Submitted: October 1, 2019
• First Submitted That Met QC Criteria: October 3, 2019
• First Posted (Actual): October 4, 2019

Study Record Updates

• Last Update Posted (Actual): October 4, 2019
• Last Update Submitted That Met QC Criteria: October 3, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: UManresa_Caregivers2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data about the protocol intervention, primary outcome measures and final report will be available for the Institution director.
• IPD Sharing Time Frame: Before the intervention starts
• IPD Sharing Access Criteria: Only for institution director
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No