NCT03965507

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2015

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 29, 2019

Completed
Last Updated

May 31, 2019

Status Verified

May 1, 2019

Enrollment Period

3 months

First QC Date

May 24, 2019

Last Update Submit

May 29, 2019

Conditions

Keywords

Disc herniaDysfunctionLumbarSacroiliac joint

Outcome Measures

Primary Outcomes (5)

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

    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

    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

    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

    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

    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

Study Arms (2)

The group with sacroiliac joint dysfunction

The patient with sacroiliac joint dysfunction in lumbar disc hernia

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

The group without sacroiliac joint dysfunction

The patient without sacroiliac joint dysfunction in lumbar disc hernia

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

Interventions

Also known as: Pain level, Presence of neuropathic pain, Functional capacity, Quality of life, Presence of depression, Presence of kinesiophobia
The group with sacroiliac joint dysfunctionThe group without sacroiliac joint dysfunction

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 11064524BACKGROUND
  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Intervertebral Disc Displacement

Interventions

Functional Residual CapacityQuality of Life

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Total Lung CapacityLung Volume MeasurementsRespiratory Function TestsDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaHealth StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Hilal Telli, MD

    European University of Lefke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor - Medical Doctor

Study Record Dates

First Submitted

May 24, 2019

First Posted

May 29, 2019

Study Start

January 22, 2015

Primary Completion

April 16, 2015

Study Completion

April 16, 2015

Last Updated

May 31, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

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