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NCT Number: NCT03965507

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

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.

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Key information

Conditions

Lumbar Disc Herniation Bone Diseases Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sacroiliac Joint Dysfunction Spinal Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evaluation of the prevalence of sacroiliac joint dysfunction in lumbar disc herniation

Other

Other names: Pain level, Presence of neuropathic pain, Functional capacity, Quality of life, Presence of depression, Presence of kinesiophobia

Primary outcomes

  1. Evaluation the prevalence of sacroiliac joint dysfunction in patients with lumbar disc hernia

    Time frame: 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.

  2. Examination of the level of pain caused by this combination which with sacroiliac joint dysfunction in lumbar disc hernia

    Time frame: 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.

  3. Examination the presence of depression caused by this combination which with sacroiliac joint dysfunction in lumbar disc hernia

    Time frame: 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.

  4. Effect on the quality of life this combination which with sacroiliac joint dysfunction in lumbar disc hernia: Health Assessment Questionnaire

    Time frame: 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.

  5. Examination the presence of kinesiophobia caused by this combination which with sacroiliac joint dysfunction in lumbar disc hernia

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

European University of Lefke

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 29, 2019
Registry last updated
May 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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