Lumbar Disc HerniationNCT03965507
The Prevalence Of Sacroiliac Joint Dysfunction In Patients With Lumbar Disc Hernia
An observational study of Lumbar Disc Herniation and Sacroiliac Joint Dysfunction, run by European University of Lefke.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Lumbar Disc Herniation, Sacroiliac Joint Dysfunction
- What is being tested?
- Evaluation of the prevalence of sacroiliac joint dysfunction in lumbar disc herniation
- How many people
- 234 participants
- Where
- No sites listed yet
- Study dates
- 22 Jan 2015to 16 Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Being tested
- Evaluation of the prevalence of sacroiliac joint dysfunction in lumbar disc herniation
- Keywords
- Disc hernia, Dysfunction, Lumbar, Sacroiliac joint
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the prevalence of sacroiliac joint dysfunction in lumbar disc herniationOther
Also called Pain level, Presence of neuropathic pain, Functional capacity, Quality of life
| Study group | Role | What they receive |
|---|---|---|
| The group with sacroiliac joint dysfunction | The patient with sacroiliac joint dysfunction in lumbar disc hernia Receives: 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 Receives: Other: Evaluation of the prevalence of sacroiliac joint dysfunction in lumbar disc herniation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start22 Jan 2015
- Primary completion16 Apr 2015
- Study completion16 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- European University of Lefke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilal Telli, European University of Lefke
- Investigators
- Hilal Telli, MD, Principal investigator, European University of Lefke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965507
- Sponsor's protocol ID
- The Prevalence Of SJD
- Status last verified
- May 2019
- First submitted
- 24 May 2019
- Last updated
- 31 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: From an ethical point of view, this data should remain between the doctor and the patients. Therefore a plan is not created.
Publications
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.
PubMed 11064524Madani 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.
PubMed 23893142Chou 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.
PubMed 14996234Prather 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.
PubMed 15767995
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Study of Patients, Who Diagnosed Lumbar Disc Hernia With or Without Sacroiliac Joint Dysfunction
- ClinicalTrials.gov ID
- NCT03965507
- Acronym / sponsor ID
- The Prevalence Of SJD
- Keywords
- Disc hernia, Dysfunction, Lumbar, Sacroiliac joint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- European University of LefkeUniversity, hospital or other
- Study start
- 22 Jan 2015 (actual)
- Primary completion
- 16 Apr 2015 (actual)
- Study completion
- 16 Apr 2015 (actual)
- First posted
- 29 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The group with sacroiliac joint dysfunction | – | Other: Evaluation of the prevalence of sacroiliac joint dysfunction in lumbar disc herniationThe patient with sacroiliac joint dysfunction in lumbar disc hernia |
| The group without sacroiliac joint dysfunction | – | Other: Evaluation of the prevalence of sacroiliac joint dysfunction in lumbar disc herniationThe patient without sacroiliac joint dysfunction in lumbar disc hernia |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of the prevalence of sacroiliac joint dysfunction in lumbar disc herniationAlso: Pain level, Presence of neuropathic pain, Functional capacity, Quality of life | Other | The group with sacroiliac joint dysfunction, The group without sacroiliac joint dysfunction |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
- Background: PubMed 11064524van 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.
- Results publication: PubMed 23893142Madani 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.
- Results publication: PubMed 14996234Chou 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.
- Results publication: PubMed 15767995Prather 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.
- Individual participant dataSharing planned: No. From an ethical point of view, this data should remain between the doctor and the patients. Therefore a plan is not created.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilal Telli, MD principal investigator
European University of Lefke
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Disc Herniation and Sacroiliac Joint Dysfunction, run by European University of Lefke.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation the prevalence of sacroiliac joint dysfunction in patients with lumbar disc hernia (time frame: 1 day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03965507, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2019.