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The Prevalence Of Sacroiliac Joint Dysfunction In Patients With Lumbar Disc Hernia

29 de mayo de 2019 actualizado por: Hilal Telli, European University of Lefke

A Cross-sectional Study of Patients, Who Diagnosed Lumbar Disc Hernia With or Without Sacroiliac Joint Dysfunction

In this study evaluated the prevalence of sacroiliac joint dysfunction in patients with lumbar disc hernia and examined the variations in clinical parameters cause by this combination.

Descripción general del estudio

Descripción detallada

Two hundred thirty-four patients already diagnosed with lumbar disc hernia were included in the study. During the evaluation, sacroiliac joint dysfunction was investigated using specific tests, pain levels with a Visual Analog Scale, and the presence of neuropathic pain using the Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale. Other clinical assessments were performed using the Beck Depression Inventory, Health Assessment Questionnaire, and Tampa Kinesiophobia Scale. Positivity in three out of six provocation tests was adopted as a criterion for sacroiliac joint dysfunction.

Sample Size A power analysis using the formula n= t2pq / d2 was performed to determine the sample size. Based on those data the investigators concluded that a minimum of 174 and a maximum of 322 patients would be required to achieve significant results, and 234 patients were enrolled.

Statistical Analysis The study data were expressed as mean plus standard deviation (SD) for constant variables values and as number and percentage for categoric variables. The chi-square test was used to analyze categoric variables. Results were evaluated at a 95% confidence interval at a significance level of p˂0.05. The analysis was performed on Statistical Package for the Social Sciences (SPSS) for Windows 16.0 software.

The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guideline has been implemented in this manuscript.

Tipo de estudio

De observación

Inscripción (Actual)

234

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

20 años a 60 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

Two hundred thirty-four patients already diagnosed with lumbar disc hernia were included in the study. 63.2% of patients were female and 36.8% were male. Mean age was 46.72 ± 11.14 years.

Descripción

Inclusion Criteria:

  • Between 20 - 60 years old
  • Diagnosis of lumbar disc herniation
  • To have sufficient cognitive level to fill clinical evaluation forms
  • The patient agreed to participate in the study

Exclusion Criteria:

  • Lumbar pain, the etiology of which was suspected to be inflammatory in character
  • Structural vertebral deformity or fracture
  • The severe and progressive neurological deficit
  • A history of severe psychiatric disease
  • Substance and/or alcohol dependence, with uncontrolled diabetes mellitus (DM), malignancy, spinal infection
  • A history of vertebral surgery
  • Pregnancy

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
The group with sacroiliac joint dysfunction
The patient with sacroiliac joint dysfunction in lumbar disc hernia
Otros nombres:
  • Calidad de vida
  • Pain level
  • Presence of neuropathic pain
  • Functional capacity
  • Presence of depression
  • Presence of kinesiophobia
The group without sacroiliac joint dysfunction
The patient without sacroiliac joint dysfunction in lumbar disc hernia
Otros nombres:
  • Calidad de vida
  • Pain level
  • Presence of neuropathic pain
  • Functional capacity
  • Presence of depression
  • Presence of kinesiophobia

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Evaluation the prevalence of sacroiliac joint dysfunction in patients with lumbar disc hernia
Periodo de tiempo: 1 day
During the evaluation, sacroiliac joint dysfunction was investigated using specific tests. Positivity in three out of six provocation tests was adopted as a criterion for sacroiliac joint dysfunction.
1 day
Examination of the level of pain caused by this combination which with sacroiliac joint dysfunction in lumbar disc hernia
Periodo de tiempo: 1 day
All patients were evaluated in terms of pain threshold measurements using a Visual Analogue Scale (VAS). The patient is asked to mark the severity of the pain on a horizontal or vertical 10 cm line. It is defined as 0 no pain, 5 moderate pain, 10 is the most severe pain encountered in life.
1 day
Examination the presence of depression caused by this combination which with sacroiliac joint dysfunction in lumbar disc hernia
Periodo de tiempo: 1 day

The presence of depression was evaluated using the Beck Depression Inventory. The Beck Depression Inventory created by Aaron T. Beck, is a 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression.

Each answer is scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms.

In this study evaluated that there is no depression between 0 and 13 points, a moderate depression of 14-24 points, and a severe depression of more than 25 points.

1 day
Effect on the quality of life this combination which with sacroiliac joint dysfunction in lumbar disc hernia: Health Assessment Questionnaire
Periodo de tiempo: 1 day
Quality of life was performed using the Health Assessment Questionnaire.The Health Assessment Questionnaire (HAQ) was originally developed in 1978 by James F. Fries, MD, and colleagues at Stanford University. The domain of disability is assessed by the eight categories of dressing, arising, eating, walking, hygiene, reach, grip, and common activities. Discomfort is determined by the presence of pain and its severity. Each answer is rated 0-3. The Health Assessment Questionnaire (HAQ) is a questionnaire that reflects the functional status, and its score is correlated with disease activity indicators.
1 day
Examination the presence of kinesiophobia caused by this combination which with sacroiliac joint dysfunction in lumbar disc hernia
Periodo de tiempo: 1 day
The presence of kinesiophobia was evaluated using the Tampa Kinesiophobia Scale.The Tampa Scale for Kinesiophobia (TSK)that was developed in 1990 is a 17 item questionnaire used to assess the subjective rating of Kinesiophobia or fear of movement. The original questionnaire was developed to "discriminate between non-excessive fear and phobia among patients with chronic musculoskeletal pain''. The TSK is a self-completed questionnaire and the range of scores are from 17 to 68 where the higher scores indicate an increasing degree of Kinesiophobia.
1 day

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Hilal Telli, MD, European University of Lefke

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

22 de enero de 2015

Finalización primaria (Actual)

16 de abril de 2015

Finalización del estudio (Actual)

16 de abril de 2015

Fechas de registro del estudio

Enviado por primera vez

24 de mayo de 2019

Primero enviado que cumplió con los criterios de control de calidad

28 de mayo de 2019

Publicado por primera vez (Actual)

29 de mayo de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

31 de mayo de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

29 de mayo de 2019

Última verificación

1 de mayo de 2019

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

From an ethical point of view, this data should remain between the doctor and the patients. Therefore a plan is not created.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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