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- Ensaio Clínico 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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Badajoz, Espanha, 06071
- Universidad de Extremadura
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Comparador Ativo: 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 |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
pressure platform and accelerometry
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
weight
Prazo: 4 weeks
|
Descriptive variable.
Its unit of measurement is Kilograms
|
4 weeks
|
Height
Prazo: 4 weeks
|
Descriptive variable.
Its unit of measurement is meters
|
4 weeks
|
age
Prazo: 4 weeks
|
Descriptive variable.
Its unit of measurement is years
|
4 weeks
|
EVA (Visual Analog Scale).
Prazo: 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
Prazo: 4 weeks
|
Algometry at 5 cm from the spinous process of L3 and in lateral epicondyl (Bilateral)
|
4 weeks
|
Joint Position Sense (JPS)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Mª Dolores MD Apolo-Arenas, PhD, Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain
- Diretor de estudo: Luis LE Espejo-Antúnez, PhD, Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain
- Investigador principal: Alejandro Caña-Pino, PT,MSc, Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 08062018
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