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

NCT ID: NCT04115670

Last Updated: 2019-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-02

Study Completion Date

2020-12-20

Brief Summary

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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

Detailed Description

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Conditions

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Chronic Low-back Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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specific intervention (experimental)

Specific intervention (experimental). The intervention group will carry out 3 sessions of specific pain education + 15 sessions of physical training.

Group Type EXPERIMENTAL

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

Intervention Type 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.

control group (no intervention)

NO intervention

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type BEHAVIORAL

The control group will follow its normal course of activity

Interventions

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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.

Intervention Type BEHAVIORAL

Control group

The control group will follow its normal course of activity

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundació Universitària del Bages

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Júlia Jubany, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Vic - Central University of Catalonia

Locations

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

Manresa, Barcelona, Spain

Site Status

Countries

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Spain

Central Contacts

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Olga Borao, PhD

Role: CONTACT

0034 938774179 ext. 363

Júlia Jubany, PhD

Role: CONTACT

0034 938774179 ext. 370

Facility Contacts

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Olga Borao, PhD

Role: primary

0034 938774179 ext. 363

Júlia Jubany, PhD

Role: backup

0034 938774179 ext. 370

References

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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.

Reference Type BACKGROUND
PMID: 10767807 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25180773 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28736211 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27568831 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22231424 (View on PubMed)

Other Identifiers

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UManresa_Caregivers2019

Identifier Type: -

Identifier Source: org_study_id

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