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

29 mei 2019 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

234

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

20 jaar tot 60 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
The group with sacroiliac joint dysfunction
The patient with sacroiliac joint dysfunction in lumbar disc hernia
Ander: Evaluation of the prevalence of sacroiliac joint dysfunction in lumbar disc herniation
Andere namen:
  • Kwaliteit van het leven
  • 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
Ander: Evaluation of the prevalence of sacroiliac joint dysfunction in lumbar disc herniation
Andere namen:
  • Kwaliteit van het leven
  • Pain level
  • Presence of neuropathic pain
  • Functional capacity
  • Presence of depression
  • Presence of kinesiophobia

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Evaluation the prevalence of sacroiliac joint dysfunction in patients with lumbar disc hernia
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

European University of Lefke

Onderzoekers

  • Hoofdonderzoeker: Hilal Telli, MD, European University of Lefke

Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

22 januari 2015

Primaire voltooiing (Werkelijk)

16 april 2015

Studie voltooiing (Werkelijk)

16 april 2015

Studieregistratiedata

Eerst ingediend

24 mei 2019

Eerst ingediend dat voldeed aan de QC-criteria

28 mei 2019

Eerst geplaatst (Werkelijk)

29 mei 2019

Updates van studierecords

Laatste update geplaatst (Werkelijk)

31 mei 2019

Laatste update ingediend die voldeed aan QC-criteria

29 mei 2019

Laatst geverifieerd

1 mei 2019

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • The Prevalence Of SJD

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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