Influence of Health Determinants on Physical Exercise Therapy With a Neurocognitive Focus on Chronic Low Back Pain
Primary Purpose
Chronic Low-back Pain
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Group of educational intervention on the neurophysiology of pain and physical exercises
Control group
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low-back Pain
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
Sites / Locations
- Universitat de Vic-Universitat de Catalunya (UVic-UCC)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
specific intervention (experimental)
control group (no intervention)
Arm Description
Specific intervention (experimental). The intervention group will carry out 3 sessions of specific pain education + 15 sessions of physical training.
NO intervention
Outcomes
Primary Outcome Measures
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)
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)
Secondary Outcome Measures
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.
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
Full Information
NCT ID
NCT04115670
First Posted
October 1, 2019
Last Updated
October 3, 2019
Sponsor
Fundació Universitària del Bages
1. Study Identification
Unique Protocol Identification Number
NCT04115670
Brief Title
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
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 2, 2019 (Anticipated)
Primary Completion Date
April 30, 2020 (Anticipated)
Study Completion Date
December 20, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Universitària del Bages
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
specific intervention (experimental)
Arm Type
Experimental
Arm Description
Specific intervention (experimental). The intervention group will carry out 3 sessions of specific pain education + 15 sessions of physical training.
Arm Title
control group (no intervention)
Arm Type
Active Comparator
Arm Description
NO intervention
Intervention Type
Behavioral
Intervention Name(s)
Group of educational intervention on the neurophysiology of pain and physical exercises
Intervention Description
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
Intervention Name(s)
Control group
Intervention Description
The control group will follow its normal course of activity
Primary Outcome Measure Information:
Title
Change from Baseline in Pain perceived at 3 months: Visual Analogue Scale
Description
Analisis of pain, using the Visual Analogue Scale, that measure from 0 (no pain) to 10 (excruciating pain)
Time Frame
Baseline and 3 months
Title
Change from Baseline in Pain perceived at 6 months: Visual Analogue Scale
Description
Analisis of pain, using the Visual Analogue Scale, that measure from 0 (no pain) to 10 (excruciating pain)
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
Change from Baseline in Fear and avoidance of movement at 3 months
Description
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.
Time Frame
Baseline and 3 months
Title
Change from Baseline in Pain disability at 3 months: Oswestry Disability Index
Description
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
Time Frame
Baseline and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olga Borao, PhD
Phone
0034 938774179
Ext
363
Email
oborao@umanresa.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Júlia Jubany, PhD
Phone
0034 938774179
Ext
370
Email
jjubany@umanresa.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Júlia Jubany, PhD
Organizational Affiliation
Universitat de Vic-Universitat Central de Catalunya
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitat de Vic-Universitat de Catalunya (UVic-UCC)
City
Manresa
State/Province
Barcelona
ZIP/Postal Code
08242
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olga Borao, PhD
Phone
0034 938774179
Ext
363
Email
oborao@umanresa.cat
First Name & Middle Initial & Last Name & Degree
Júlia Jubany, PhD
Phone
0034 938774179
Ext
370
Email
jjubany@umanresa.cat
First Name & Middle Initial & Last Name & Degree
Mireia Campoy, University
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
22231424
Citation
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.
Results Reference
background
PubMed Identifier
10767807
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.
Results Reference
background
PubMed Identifier
25180773
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.
Results Reference
background
PubMed Identifier
28736211
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.
Results Reference
background
PubMed Identifier
27568831
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.
Results Reference
background
Learn more about this trial
Influence of Health Determinants on Physical Exercise Therapy With a Neurocognitive Focus on Chronic Low Back Pain
We'll reach out to this number within 24 hrs