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

Study Overview
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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

Official Title
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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

Conditions
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Chronic Low-back Pain

Intervention / Treatment
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* Behavioral: Group of educational intervention on the neurophysiology of pain and physical exercises
* Behavioral: Control group


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: specific intervention (experimental)<br>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<br>* 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.<br>|
| Active Comparator: control group (no intervention)<br>NO intervention | Behavioral: Control group<br>* The control group will follow its normal course of activity<br>|

What is the study measuring?
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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 |