MedDataX Logo

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

NCT ID: NCT03965507

Last Updated: 2019-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

234 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-22

Study Completion Date

2015-04-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lumbar Disc Herniation Sacroiliac Joint Dysfunction

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Disc hernia Dysfunction Lumbar Sacroiliac joint

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

The group with sacroiliac joint dysfunction

The patient with sacroiliac joint dysfunction in lumbar disc hernia

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

Intervention Type OTHER

The group without sacroiliac joint dysfunction

The patient without sacroiliac joint dysfunction in lumbar disc hernia

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

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Pain level Presence of neuropathic pain Functional capacity Quality of life Presence of depression Presence of kinesiophobia

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

European University of Lefke

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hilal Telli

Assistant Professor - Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hilal Telli, MD

Role: PRINCIPAL_INVESTIGATOR

European University of Lefke

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 11064524 (View on PubMed)

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.

Reference Type RESULT
PMID: 23893142 (View on PubMed)

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.

Reference Type RESULT
PMID: 14996234 (View on PubMed)

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.

Reference Type RESULT
PMID: 15767995 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

The Prevalence Of SJD

Identifier Type: -

Identifier Source: org_study_id