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

NCT04115670 | Unknown

• 1 other identifier: UManresa_Caregivers2019
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Low-back Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change from Baseline in Fear and avoidance of movement at 3 months

  Baseline and 3 months

• Change from Baseline in Pain disability at 3 months: Oswestry Disability Index

  Baseline and 3 months

Study Arms (2)

specific intervention (experimental)

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

control group (no intervention)

ACTIVE COMPARATOR

NO intervention

Behavioral: Control group

Interventions

Group of educational intervention on the neurophysiology of pain and physical exercises BEHAVIORAL

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.

specific intervention (experimental)

Control group BEHAVIORAL

The control group will follow its normal course of activity

control group (no intervention)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundació Universitària del Bages: lead

Study Sites (1)

Universitat de Vic-Universitat de Catalunya (UVic-UCC)

Manresa, Barcelona, 08242, Spain

Location

Related Publications (5)

• 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.

  PMID: 22231424 BACKGROUND

• 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.

  PMID: 10767807 BACKGROUND

• 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.

  PMID: 25180773 BACKGROUND

• 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.

  PMID: 28736211 BACKGROUND

• 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.

  PMID: 27568831 BACKGROUND

MeSH Terms

Interventions

Exercise; Control Groups

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Júlia Jubany, PhD

  University of Vic - Central University of Catalonia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olga Borao, PhD

CONTACT

0034 938774179; oborao@umanresa.cat

Júlia Jubany, PhD

CONTACT

0034 938774179; jjubany@umanresa.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 4, 2019
• Study Start: December 2, 2019
• Primary Completion: April 30, 2020
• Study Completion: December 20, 2020
• Last Updated: October 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Before the intervention starts
• Access Criteria: Only for institution director

Locations

ES (1)