Lumbar Disc HerniationNCT06120517
The Relationship Between Lumbar Disc Herniation and Urinary Incontinence
An observational study of Lumbar Disc Herniation, run by Sanko University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this research; To evaluate the relationship between low back pain and pelvic floor muscle strength, urinary incontinence, constipation and sexual dysfunction in female individuals with lumbar disc herniation. No study on this has been found in the literature. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- emg- biofeedback
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 1 Jun 2024
- 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 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Study population: Female individuals between the ages of 18-55 diagnosed with lumbar disc herniation will be included in our study.
Who may be able to join
- Diagnosed with Protruded and Extruded Lumbar Disc Herniation, Those who are between the ages of 18-55, BMI below 30 kg/m2
Who cannot join
- Trauma, Tumoral Causes - Cancer, Signs of neurological disease, Diabetus Mellitus, Hypertension etc. systemic disorder, Operated Disc Herniation, pregnancy, Those diagnosed with sequestered disc herniation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sanko University
Gaziantep, Şehitkamil, 27500
selver seval soğan, +905525864646, selver.sogan@sankotip.com
About this study
Official title: The Relationship Between Low Back Pain and Pelvic Floor Muscle Strength, Urinary
The purpose of this research; To evaluate the relationship between low back pain and pelvic floor muscle strength, urinary incontinence, constipation and sexual dysfunction in female individuals with lumbar disc herniation. No study on this has been found in the literature.
Hypotheses of the study; Ho: ''There is no difference in terms of the relationship between low back pain and Pelvic Floor Muscle Strength, Urinary Incontinence, Constipation and Sexual Dysfunction in Female Individuals with Lumbar Disc Herniation.'' H1: ''There is a difference in terms of the relationship between low back pain and Pelvic Floor Muscle Strength, Urinary Incontinence, Constipation and Sexual Dysfunction in Female Individuals with Lumbar Disc Herniation.''
Read the detailed description
Low back pain is a problem that is caused by overwork and impaired functional capacity. It has been observed that the source of low back pain is due to intervertebral disc pathologies at a rate of up to 39%. Lumbar disc herniation; Low back pain, manicure and numbness in fullness or cracks, muscle weakness, difficulty in moving, weakness, inability to hold places, pulling when sitting and deterioration in conditions, sudden stabbing pain in the waist area when coughing or sneezing, bursting of the herniated nucleus pulposus (nucleus pulposus). Lumbar disc herniation can be detected in non-symptomatic cases. Lumbar disc herniation, Protruded disc herniation (eccentric overflow is present; the annulus is intact), Extruded disc herniation (the nucleus has passed the ruptured annulus; however, there is still a connection with the nucleus formation at the disc borders.), Sequestered disc herniation (The residual piece has ruptured with the disc space and It is in the form of a free fragment.). One of the biggest causes of lower back pain is the weakness of the core muscles and their not being active at the right time. It is documented as a cylindrical shaped structure that provides the distance between the core, body, fillings and arms. The role of active, passive and normal structures in core stabilization can be sustained. Passive structures; bone, cartilage and connective tissues, and active structures consist of muscles. Core muscles in core stability; The respiratory muscles are the diaphragm, transversus abdominus muscle, multifidus muscle and pelvic floor muscles. These muscles create trunk and lumbo-pelvic stability and have a very important role in the muscular chain. In addition, it seems that the ability to remember sequences and the activation responses of these muscles are impaired or slowed down. It can cause dysfunction, especially in the transversus abdominus, multifudus and pelvic floor muscles.
The purpose of this research; To evaluate the relationship between low back pain and pelvic floor muscle strength, urinary incontinence, constipation and sexual dysfunction in female individuals with lumbar disc herniation. No study on this has been found in the literature.
Hypotheses of the study; Ho: ''There is no difference in terms of the relationship between low back pain and Pelvic Floor Muscle Strength, Urinary Incontinence, Constipation and Sexual Dysfunction in Female Individuals with Lumbar Disc Herniation.'' H1: ''There is a difference in terms of the relationship between low back pain and Pelvic Floor Muscle Strength, Urinary Incontinence, Constipation and Sexual Dysfunction in Female Individuals with Lumbar Disc Herniation.''
- Conditions
- Lumbar Disc Herniation
- Being tested
- emg- biofeedback
- 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.
emg- biofeedbackCombination product
EMG activity shows the electrical activity measured during striated muscle contraction. The electrical activity of the muscle is in microvolts (1 volt = 1,000,000μV). Biofeedback units usually produce audio or visual feedback depending on the amount of electrical activity. Recording the bio-electrical activity of the muscle is a practical indicator of its contractility.
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Low Back Pain Disability Questionnaire
Oswestry Low Back Pain Disability Questionnaire: This test is designed to obtain information about how much your back (or leg) complaint affects your daily life. It includes sections such as pain intensity, personal care (washing, dressing, etc.), lifting loads, walking, sitting, standing, sleep, sexual life (if applicable), social life, and travel. There are 6 sub-items in each section. The numbers next to the marked sub-items are added up. If there is more than 1 checked option in the same question, the highest value is taken. The maximum score is 50. The total score is calculated as = {[total score] /[(number of marked questions)x5]}x100. The validation of the Turkish version of the Oswestry Disability Index for patients with low back pain was made in our country in 2004 by Yakut, Düger, Öksüz, Yörükan, Üreten, Turan, Kardeşliği, Kiraz, Krd, Kayhan Yakut, Güler
Measured: 1 weeks
Pelvic Floor Muscle Strength Measurement
It is the measurement of the electrical activity occurring during pelvic floor muscle contraction and relaxation using superficial electrodes and reflecting it on the screen with appropriate equipment. The active electrode can be applied to the perineal area at 2 and 7 o'clock, 3 and 9 o'clock, or 5 and 11 o'clock. The reference electrode is usually attached to the adductor muscle group or medial to the tuber ischii. If dual channels are to be used, electrodes are placed on the abdomen. When evaluating pelvic floor muscle activity, segments such as basal rest, tonic activity - slow twitch muscles, phasic activity - fast twitch muscles, endurance are evaluated. In sEmg analysis, values such as work average, rest average, release average, onset average, peak and minimum are recorded.
Measured: 1 weeks
King Health Survey
It is a tool recommended by the European Clinical Practice Guidelines. It is a frequently used questionnaire to evaluate the quality of life of patients with incontinence, consisting of 32 items and two parts. It includes 7 subheadings consisting of multiple items in addition to two single-item questions such as general health status and impact on quality of life. These include: role limitations, physical limitations, social limitations, limitations in personal relationships, emotional problems, incontinence-related sleep and energy disorders, and severity measurements for incontinence. The second part is the 11-item Symptom Severity Scale, which evaluates the presence and severity of urinary symptoms. The score of the Symptom Severity Scale varies between 0 (best) and 30 (worst). For other survey areas, scores range from 0 (best) to 100 (worst). The Turkish reliability and validity of the survey was tested in 2015.
Measured: 1 weeks
Constipation Severity Scale
There are 16 questions in total within the scope of the scale. It includes Large Intestinal Laziness, Fecal Obstruction and Pain subdimension. The score in the Large Intestinal Laziness dimension is between 0 and 29, the score in the Fecal Obstruction dimension is between 0 and 28, and the score in the Pain dimension is between 0 and 16. In this context, the lowest score that can be obtained is 0, while the highest score is 73. High scores from the scale indicate that the symptoms are at a serious level. The reliability and validity study of this scale was conducted in our country by Kaya and Turan in 2011.
Measured: 1 weeks
Sexual Quality of Life Scale - Female
This scale is a six-point Likert type and consists of 18 items. Each item is expected to be answered considering your sexual life in the last four weeks. In evaluating the scale, an item is scored between 1 and 6 (1 = Completely agree, 2 = Largely agree, 3 = Partially agree, 4 = Partially disagree, 5 = Largely disagree, 6 = Strongly disagree). The score range that can be obtained from the scale varies between 18-108. In this point system, the total score received from the scale is converted to 100. To convert the total scale score to 100; It is stated that the formula (raw score taken from the scale -18)x100/90 should be used. For example, the scale score of an individual whose total raw score from the scale is 63 is converted to 100; (63- 18)x100/90=50. A high score from the scale indicates that the quality of sexual life is good. The validity and reliability study of the Turkish version of this scale was conducted in our country by Tuğut and Gölbaşı in 2010.
Measured: 1 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Jun 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanko University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selver Soğan, Sanko University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06120517
- Sponsor's protocol ID
- FztSelverSevalSogan
- Status last verified
- Nov 2023
- First submitted
- 2 Nov 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Low Back Pain and Pelvic Floor Muscle Strength, Urinary
- ClinicalTrials.gov ID
- NCT06120517
- Acronym / sponsor ID
- FztSelverSevalSogan
- Conditions
- Lumbar Disc Herniation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Sanko UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 7 Nov 2023 (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.
The purpose of this research; To evaluate the relationship between low back pain and pelvic floor muscle strength, urinary incontinence, constipation and sexual dysfunction in female individuals with lumbar disc herniation. No study on this has been found in the literature.
Hypotheses of the study; Ho: ''There is no difference in terms of the relationship between low back pain and Pelvic Floor Muscle Strength, Urinary Incontinence, Constipation and Sexual Dysfunction in Female Individuals with Lumbar Disc Herniation.'' H1: ''There is a difference in terms of the relationship between low back pain and Pelvic Floor Muscle Strength, Urinary Incontinence, Constipation and Sexual Dysfunction in Female Individuals with Lumbar Disc Herniation.''
Detailed description
Low back pain is a problem that is caused by overwork and impaired functional capacity. It has been observed that the source of low back pain is due to intervertebral disc pathologies at a rate of up to 39%. Lumbar disc herniation; Low back pain, manicure and numbness in fullness or cracks, muscle weakness, difficulty in moving, weakness, inability to hold places, pulling when sitting and deterioration in conditions, sudden stabbing pain in the waist area when coughing or sneezing, bursting of the herniated nucleus pulposus (nucleus pulposus). Lumbar disc herniation can be detected in non-symptomatic cases. Lumbar disc herniation, Protruded disc herniation (eccentric overflow is present; the annulus is intact), Extruded disc herniation (the nucleus has passed the ruptured annulus; however, there is still a connection with the nucleus formation at the disc borders.), Sequestered disc herniation (The residual piece has ruptured with the disc space and It is in the form of a free fragment.). One of the biggest causes of lower back pain is the weakness of the core muscles and their not being active at the right time. It is documented as a cylindrical shaped structure that provides the distance between the core, body, fillings and arms. The role of active, passive and normal structures in core stabilization can be sustained. Passive structures; bone, cartilage and connective tissues, and active structures consist of muscles. Core muscles in core stability; The respiratory muscles are the diaphragm, transversus abdominus muscle, multifidus muscle and pelvic floor muscles. These muscles create trunk and lumbo-pelvic stability and have a very important role in the muscular chain. In addition, it seems that the ability to remember sequences and the activation responses of these muscles are impaired or slowed down. It can cause dysfunction, especially in the transversus abdominus, multifudus and pelvic floor muscles.
The purpose of this research; To evaluate the relationship between low back pain and pelvic floor muscle strength, urinary incontinence, constipation and sexual dysfunction in female individuals with lumbar disc herniation. No study on this has been found in the literature.
Hypotheses of the study; Ho: ''There is no difference in terms of the relationship between low back pain and Pelvic Floor Muscle Strength, Urinary Incontinence, Constipation and Sexual Dysfunction in Female Individuals with Lumbar Disc Herniation.'' H1: ''There is a difference in terms of the relationship between low back pain and Pelvic Floor Muscle Strength, Urinary Incontinence, Constipation and Sexual Dysfunction in Female Individuals with Lumbar Disc Herniation.''
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Female individuals between the ages of 18-55 diagnosed with lumbar disc herniation will be included in our study.
Key inclusion criteria (1 listed)
- Diagnosed with Protruded and Extruded Lumbar Disc Herniation, Those who are between the ages of 18-55, BMI below 30 kg/m2
Key exclusion criteria (1 listed)
- Trauma, Tumoral Causes - Cancer, Signs of neurological disease, Diabetus Mellitus, Hypertension etc. systemic disorder, Operated Disc Herniation, pregnancy, Those diagnosed with sequestered disc herniation
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 |
|---|---|---|
| emg- biofeedbackEMG activity shows the electrical activity measured during striated muscle contraction. The electrical activity of the muscle is in microvolts (1 volt = 1,000,000μV). Biofeedback units usually produce audio or visual feedback depending on the amount of electrical activity. Recording the bio-electrical activity of the muscle is a practical indicator of its contractility. | Combination product | – |
Primary outcome
Oswestry Low Back Pain Disability Questionnaire
Time frame: 1 weeks
Oswestry Low Back Pain Disability Questionnaire: This test is designed to obtain information about how much your back (or leg) complaint affects your daily life. It includes sections such as pain intensity, personal care (washing, dressing, etc.), lifting loads, walking, sitting, standing, sleep, sexual life (if applicable), social life, and travel. There are 6 sub-items in each section. The numbers next to the marked sub-items are added up. If there is more than 1 checked option in the same question, the highest value is taken. The maximum score is 50. The total score is calculated as = {[total score] /[(number of marked questions)x5]}x100. The validation of the Turkish version of the Oswestry Disability Index for patients with low back pain was made in our country in 2004 by Yakut, Düger, Öksüz, Yörükan, Üreten, Turan, Kardeşliği, Kiraz, Krd, Kayhan Yakut, Güler
Pelvic Floor Muscle Strength Measurement
Time frame: 1 weeks
It is the measurement of the electrical activity occurring during pelvic floor muscle contraction and relaxation using superficial electrodes and reflecting it on the screen with appropriate equipment. The active electrode can be applied to the perineal area at 2 and 7 o'clock, 3 and 9 o'clock, or 5 and 11 o'clock. The reference electrode is usually attached to the adductor muscle group or medial to the tuber ischii. If dual channels are to be used, electrodes are placed on the abdomen. When evaluating pelvic floor muscle activity, segments such as basal rest, tonic activity - slow twitch muscles, phasic activity - fast twitch muscles, endurance are evaluated. In sEmg analysis, values such as work average, rest average, release average, onset average, peak and minimum are recorded.
King Health Survey
Time frame: 1 weeks
It is a tool recommended by the European Clinical Practice Guidelines. It is a frequently used questionnaire to evaluate the quality of life of patients with incontinence, consisting of 32 items and two parts. It includes 7 subheadings consisting of multiple items in addition to two single-item questions such as general health status and impact on quality of life. These include: role limitations, physical limitations, social limitations, limitations in personal relationships, emotional problems, incontinence-related sleep and energy disorders, and severity measurements for incontinence. The second part is the 11-item Symptom Severity Scale, which evaluates the presence and severity of urinary symptoms. The score of the Symptom Severity Scale varies between 0 (best) and 30 (worst). For other survey areas, scores range from 0 (best) to 100 (worst). The Turkish reliability and validity of the survey was tested in 2015.
Constipation Severity Scale
Time frame: 1 weeks
There are 16 questions in total within the scope of the scale. It includes Large Intestinal Laziness, Fecal Obstruction and Pain subdimension. The score in the Large Intestinal Laziness dimension is between 0 and 29, the score in the Fecal Obstruction dimension is between 0 and 28, and the score in the Pain dimension is between 0 and 16. In this context, the lowest score that can be obtained is 0, while the highest score is 73. High scores from the scale indicate that the symptoms are at a serious level. The reliability and validity study of this scale was conducted in our country by Kaya and Turan in 2011.
Sexual Quality of Life Scale - Female
Time frame: 1 weeks
This scale is a six-point Likert type and consists of 18 items. Each item is expected to be answered considering your sexual life in the last four weeks. In evaluating the scale, an item is scored between 1 and 6 (1 = Completely agree, 2 = Largely agree, 3 = Partially agree, 4 = Partially disagree, 5 = Largely disagree, 6 = Strongly disagree). The score range that can be obtained from the scale varies between 18-108. In this point system, the total score received from the scale is converted to 100. To convert the total scale score to 100; It is stated that the formula (raw score taken from the scale -18)x100/90 should be used. For example, the scale score of an individual whose total raw score from the scale is 63 is converted to 100; (63- 18)x100/90=50. A high score from the scale indicates that the quality of sexual life is good. The validity and reliability study of the Turkish version of this scale was conducted in our country by Tuğut and Gölbaşı in 2010.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Disc Herniation, run by Sanko University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Selver Seval Soğan (+905525864646, selver.sogan@sankotip.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Low Back Pain Disability Questionnaire (time frame: 1 weeks). 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?
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 7 Nov 2023.