Clinical trial NCT03965507: The Prevalence Of Sacroiliac Joint Dysfunction In Patients With Lumbar Disc Hernia
Official title: A Cross-sectional Study of Patients, Who Diagnosed Lumbar Disc Hernia With or Without Sacroiliac Joint Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbar Disc Herniation
Sacroiliac Joint Dysfunction
Keywords: Disc hernia
Dysfunction
Lumbar
Sacroiliac joint
Lead sponsor: European University of Lefke
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 234
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation the prevalence of sacroiliac joint dysfunction in patients with lumbar disc hernia
timeFrame: 1 day
measure: Examination of the level of pain caused by this combination which with sacroiliac joint dysfunction in lumbar disc hernia
timeFrame: 1 day
measure: Examination the presence of depression caused by this combination which with sacroiliac joint dysfunction in lumbar disc hernia
timeFrame: 1 day
measure: Effect on the quality of life this combination which with sacroiliac joint dysfunction in lumbar disc hernia: Health Assessment Questionnaire
timeFrame: 1 day
measure: Examination the presence of kinesiophobia caused by this combination which with sacroiliac joint dysfunction in lumbar disc hernia
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: European University of Lefke
name: Hilal Telli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Tulder M, Malmivaara A, Esmail R, Koes B. Exercise therapy for low back pain: a systematic review within the framework of the cochrane collaboration back review group. Spine (Phila Pa 1976). 2000 Nov 1;25(21):2784-96. doi: 10.1097/00007632-200011010-00011.
citation: Madani SP, Dadian M, Firouznia K, Alalawi S. Sacroiliac joint dysfunction in patients with herniated lumbar disc: a cross-sectional study. J Back Musculoskelet Rehabil. 2013;26(3):273-8. doi: 10.3233/BMR-130376.
citation: Chou LH, Slipman CW, Bhagia SM, Tsaur L, Bhat AL, Isaac Z, Gilchrist R, El Abd OH, Lenrow DA. Inciting events initiating injection-proven sacroiliac joint syndrome. Pain Med. 2004 Mar;5(1):26-32. doi: 10.1111/j.1526-4637.2004.04009.x.
citation: Prather H, Hunt D. Conservative management of low back pain, part I. Sacroiliac joint pain. Dis Mon. 2004 Dec;50(12):670-83. doi: 10.1016/j.disamonth.2004.12.004. No abstract available.