- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03635242
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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 )
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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Badajoz, Spagna, 06071
- Universidad de Extremadura
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Comparatore attivo: 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
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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
|
Sperimentale: 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 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
pressure platform and accelerometry
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
weight
Lasso di tempo: 4 weeks
|
Descriptive variable.
Its unit of measurement is Kilograms
|
4 weeks
|
Height
Lasso di tempo: 4 weeks
|
Descriptive variable.
Its unit of measurement is meters
|
4 weeks
|
age
Lasso di tempo: 4 weeks
|
Descriptive variable.
Its unit of measurement is years
|
4 weeks
|
EVA (Visual Analog Scale).
Lasso di tempo: 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
Lasso di tempo: 4 weeks
|
Algometry at 5 cm from the spinous process of L3 and in lateral epicondyl (Bilateral)
|
4 weeks
|
Joint Position Sense (JPS)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
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The Tampa Kinesiofobia Scale (TSK)
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Mª Dolores MD Apolo-Arenas, PhD, Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain
- Direttore dello studio: Luis LE Espejo-Antúnez, PhD, Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain
- Investigatore principale: Alejandro Caña-Pino, PT,MSc, Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 08062018
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Control. no therapeutic program
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Ananda Basu, MDNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); DexCom... e altri collaboratoriCompletatoDiabete di tipo 1Stati Uniti