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

Chronic Low-back Pain Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04115670
• Other study ID #: UManresa_Caregivers2019
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2, 2019
• Est. completion date: December 20, 2020

Study information

• Verified date: October 2019
• Source: Fundació Universitària del Bages
• Contact: Olga Borao, PhD
• Phone: 0034 938774179
• Email: oborao[@]umanresa.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 20, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

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.
• Control group
The control group will follow its normal course of activity

Locations

Country	Name	City	State
Spain	Universitat de Vic-Universitat de Catalunya (UVic-UCC)	Manresa	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Universitària del Bages

Country where clinical trial is conducted

Spain, 

References & 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. Review. — View 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;(9):CD000963. doi: 10.1002/14651858.CD000963.pub3. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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