Characterization by Clinimetric Indicators of Chronic Low Back Pain Subjects Versus Healed Patients
Characterization by Clinimetric Indicators of Chronic Low Back Pain Subjects Versus Post-treatment Healed Patients by Therapeutic Exercise
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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 )
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
-
Badajoz, Spanien, 06071
- Universidad de Extremadura
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver 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
|
|
Experimental: 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 |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
pressure platform and accelerometry
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
weight
Zeitfenster: 4 weeks
|
Descriptive variable.
Its unit of measurement is Kilograms
|
4 weeks
|
|
Height
Zeitfenster: 4 weeks
|
Descriptive variable.
Its unit of measurement is meters
|
4 weeks
|
|
age
Zeitfenster: 4 weeks
|
Descriptive variable.
Its unit of measurement is years
|
4 weeks
|
|
EVA (Visual Analog Scale).
Zeitfenster: 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
Zeitfenster: 4 weeks
|
Algometry at 5 cm from the spinous process of L3 and in lateral epicondyl (Bilateral)
|
4 weeks
|
|
Joint Position Sense (JPS)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Mª Dolores MD Apolo-Arenas, PhD, Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain
- Studienleiter: Luis LE Espejo-Antúnez, PhD, Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain
- Hauptermittler: Alejandro Caña-Pino, PT,MSc, Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 08062018
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .