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Characterization by Clinimetric Indicators of Chronic Low Back Pain Subjects Versus Healed Patients

16. marts 2020 opdateret af: Alejandro Caña Pino, University of Extremadura

Characterization by Clinimetric Indicators of Chronic Low Back Pain Subjects Versus Post-treatment Healed Patients by Therapeutic Exercise

Pretending with the use of accelerometers and pressure platform, determine indicators that are useful to therapists to assess postural control and balance, to subsequently allow to evaluate the effect of therapeutic interventions through therapeutic exercise of motor control in patients with chronic low back pain .

Studieoversigt

Detaljeret beskrivelse

The records are made simultaneously with the different evaluation equipment, accelerometer and pressure platform. The tests are performed in a control group of healthy subjects, and in an experimental group with DLC receiving a program of therapeutic exercise based and pain education based on neuroscience.

After the collection of the records, the behavior patterns in both groups are evaluated, the possible differences among them are established for the clinimetric indicators analyzed related to the postural control, as well as a characteristic of the sample.

Subsequently, through the evaluation after the intervention of the experimental group we will analyze the effect of a physiotherapy treatment based on the therapeutic exercise of motor control on parameters related to postural control and clinical variables (perceived pain, mechanosensitivity, disability and proprioceptive repositioning of the lumbar spine )

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Badajoz, Spanien, 06071
        • Universidad de Extremadura

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 45 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • low back pain with painful perception on a daily or almost daily basis for more than three months of clinical course, with or without pain radiating to the lower extremities above the knee.
  • not having metal implants in the spine
  • own ability to read and write
  • and access the study voluntarily.

Exclusion Criteria:

  • vestibular disorders
  • without severe visual impairment
  • no medication intake with a potential effect on balance during the 90 days prior to data collection
  • physiotherapy treatment 2 weeks before the study

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Control. no therapeutic program
The control group continued to perform their daily activities without changing any habit. Group of healthy subjects Assessment of postural control through accelerometry and pressure platform
The control group continued to perform their daily activities without changing any habit. Group of healthy subjects Assessment of postural control through accelerometry and pressure platform
Eksperimentel: Experimental. Therapeutic program

People with chronic back pain of at least 3 months duration, to whom the therapeutic exercise of motor control and pain education based on neuroscience will be applied 2 days a week for 2 months.

Prior to the intervention, a postural control assessment will be made by accelerometry and pressure platform

People with chronic back pain of at least 3 months duration, to whom the therapeutic exercise of motor control and pain education based on neuroscience will be applied 2 days a week for 2 months.

Prior to the intervention, a postural control assessment will be made by accelerometry and pressure platform

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
pressure platform and accelerometry
Tidsramme: 4 weeks
Stay for 30 seconds each test on a pressure platform. Accelerometer in the pelvis (center of mass), fixed by velcro tape. Application of the Romberg test. (Standing with open eyes and closed on stable and unstable surface).The unit of the accelerometer is mg (1 mg = 0.001) and the kinetic energy of the signal is measured in Julians x 10-6 The displacement unit of the pressure center of the platform is millimeters
4 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
weight
Tidsramme: 4 weeks
Descriptive variable. Its unit of measurement is Kilograms
4 weeks
Height
Tidsramme: 4 weeks
Descriptive variable. Its unit of measurement is meters
4 weeks
age
Tidsramme: 4 weeks
Descriptive variable. Its unit of measurement is years
4 weeks
EVA (Visual Analog Scale).
Tidsramme: 4 weeks
Used for pain assessment in an analogical way, that is, by means of a line of 10 centimeters. 0 (absence of pain); 10 (maximum pain)
4 weeks
Algometry
Tidsramme: 4 weeks
Algometry at 5 cm from the spinous process of L3 and in lateral epicondyl (Bilateral)
4 weeks
Joint Position Sense (JPS)
Tidsramme: 4 weeks
Joint Position Sense (JPS) to evaluate the proprioceptive joint positioning of the lumbar spine with a digital goniometer at 30º flexion in standing and sitting
4 weeks
Roland Morris
Tidsramme: 4 weeks
determine the degree of disability. The extreme values oscillate between 0 (absence of disability due to low back pain) and 24 (maximum possible disability)
4 weeks
Oswestry Disability Index
Tidsramme: 4 weeks

The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability

Scoring instructions For each section of the total possible score is 5: if the first statement is mark ed the section score = 0; if the last statement is marked, it = 5.

4 weeks
Pain Catastrophizing Scale (PCS)
Tidsramme: 4 weeks

it measures the catastrophic thoughts before the pain, that is, the negative thought before the pain. In the PCS, people take the painful past experience as a reference and indicate the degree to which they experience certain thoughts and feelings. The PCS is composed of 13 items, on a Likert scale of 5 points that goes from 0 (never) to 4 (always).

Higher scores indicate higher levels of catastrophism

4 weeks
The Tampa Kinesiofobia Scale (TSK)
Tidsramme: 4 weeks
It is commonly used in clinical practice to quantify pain levels related to fear of activity or to a new injury in patients with back pain. Patients with high levels of kinesiofobia are often considered at greater risk of developing long-term activity limitation and chronicity
4 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Studieleder: Mª Dolores MD Apolo-Arenas, PhD, Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain
  • Studieleder: Luis LE Espejo-Antúnez, PhD, Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain
  • Ledende efterforsker: Alejandro Caña-Pino, PT,MSc, Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

8. juni 2018

Primær færdiggørelse (Faktiske)

8. august 2018

Studieafslutning (Faktiske)

9. oktober 2018

Datoer for studieregistrering

Først indsendt

10. august 2018

Først indsendt, der opfyldte QC-kriterier

14. august 2018

Først opslået (Faktiske)

17. august 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. marts 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. marts 2020

Sidst verificeret

1. marts 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 08062018

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