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

2019年5月29日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

観察的

入学 (実際)

234

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

20年~60年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

確率サンプル

調査対象母集団

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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
The group with sacroiliac joint dysfunction
The patient with sacroiliac joint dysfunction in lumbar disc hernia
他の名前:
  • 生活の質
  • 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
他の名前:
  • 生活の質
  • Pain level
  • Presence of neuropathic pain
  • Functional capacity
  • Presence of depression
  • Presence of kinesiophobia

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Evaluation the prevalence of sacroiliac joint dysfunction in patients with lumbar disc hernia
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Hilal Telli, MD、European University of Lefke

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2015年1月22日

一次修了 (実際)

2015年4月16日

研究の完了 (実際)

2015年4月16日

試験登録日

最初に提出

2019年5月24日

QC基準を満たした最初の提出物

2019年5月28日

最初の投稿 (実際)

2019年5月29日

学習記録の更新

投稿された最後の更新 (実際)

2019年5月31日

QC基準を満たした最後の更新が送信されました

2019年5月29日

最終確認日

2019年5月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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