Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04115670
Recruitment Status : Not yet recruiting
First Posted : October 4, 2019
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Fundació Universitària del Bages

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


Condition or disease Intervention/treatment Phase
Chronic Low-back Pain Behavioral: Group of educational intervention on the neurophysiology of pain and physical exercises Behavioral: Control group Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : December 2, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : December 20, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: specific intervention (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

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.

Active Comparator: control group (no intervention)
NO intervention
Behavioral: Control group
The control group will follow its normal course of activity




Primary Outcome Measures :
  1. Change from Baseline in Pain perceived at 3 months: Visual Analogue Scale [ Time Frame: Baseline and 3 months ]
    Analisis of pain, using the Visual Analogue Scale, that measure from 0 (no pain) to 10 (excruciating pain)

  2. Change from Baseline in Pain perceived at 6 months: Visual Analogue Scale [ Time Frame: Baseline and 6 months ]
    Analisis of pain, using the Visual Analogue Scale, that measure from 0 (no pain) to 10 (excruciating pain)


Secondary Outcome Measures :
  1. Change from Baseline in Fear and avoidance of movement at 3 months [ Time Frame: Baseline and 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.

  2. Change from Baseline in Pain disability at 3 months: Oswestry Disability Index [ Time Frame: Baseline and 3 months ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04115670


Contacts
Layout table for location contacts
Contact: Olga Borao, PhD 0034 938774179 ext 363 oborao@umanresa.cat
Contact: Júlia Jubany, PhD 0034 938774179 ext 370 jjubany@umanresa.cat

Locations
Layout table for location information
Spain
Universitat de Vic-Universitat de Catalunya (UVic-UCC)
Manresa, Barcelona, Spain, 08242
Contact: Olga Borao, PhD    0034 938774179 ext 363    oborao@umanresa.cat   
Contact: Júlia Jubany, PhD    0034 938774179 ext 370    jjubany@umanresa.cat   
Sub-Investigator: Mireia Campoy, University         
Sponsors and Collaborators
Fundació Universitària del Bages
Investigators
Layout table for investigator information
Principal Investigator: Júlia Jubany, PhD Universitat de Vic-Universitat Central de Catalunya
Publications:
Layout table for additonal information
Responsible Party: Fundació Universitària del Bages
ClinicalTrials.gov Identifier: NCT04115670    
Other Study ID Numbers: UManresa_Caregivers2019
First Posted: October 4, 2019    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data about the protocol intervention, primary outcome measures and final report will be available for the Institution director.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Before the intervention starts
Access Criteria: Only for institution director

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms