Multiple SclerosisNCT05374811
The Relationship of Neuropathic Pain With Incontinence, Disability and Life Quality in Multiple Sclerosis Patients
An observational study of Multiple Sclerosis and Disabilities Multiple, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study to evaluate the relationship of neuropathic pain with urinary and bowel incontinence, functional disability and quality of life in patients with multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Disabilities Multiple, Quality of Life
- What is being tested?
- Neuropathic Pain
- How many people
- 175 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2022to 15 Nov 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: It will consist of patients who applied to the Istanbul University Cerrahpaşa Neurology Multiple sclerosis outpatient clinic between the dates of the study.
Who may be able to join
- Being diagnosed with MS according to the 2017 Revised McDonald criteria
- Being between the ages of 18-65
- Being in remission (no progression in attacks or disability in the last 3 months).
Who cannot join
- Having another known neurological disease
- Having been diagnosed with a psychiatric disease such as depression, anxiety, bipolar disorder
- Having a history of infectious, chronic inflammatory disease, malignancy
- Having cardiac pathology such as heart failure, coronary artery disease
- Diabetes, chronic kidney failure, chronic liver failure
- Being addicted to alcohol and substance
- Using permanent urinary catheter
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship of Neuropathic Pain With Incontinence, Functional Disability and Quality of Life in Patients With Multiple Sclerosis
The aim of this study to evaluate the relationship of neuropathic pain with urinary and bowel incontinence, functional disability and quality of life in patients with multiple sclerosis.
Read the detailed description
The patient's date of birth, gender, education level, body mass index, occupation, marital status, socioeconomic status, who they live with, the onset of their complaints about the disease, the time of diagnosis of multiple sclerosis (MS), the type of MS, the presence of any pain and the type of pain will be recorded.
Then, while the patients will be evaluated by researcher Dr Alper Mengi in terms of neuropathic pain, incotinance, disability and independence in activities of daily living. The forms to be used in terms of health perceptions and quality of life, anxiety and depression, and sleep quality will be filled by the patients.
- Conditions
- Multiple Sclerosis, Disabilities Multiple, Quality of Life, Incontinence, Urinary, Incontinence Bowel, Neuropathic Pain
- Being tested
- Neuropathic Pain
- Medical subject headings
- Multiple Sclerosis, Urinary Incontinence, Encopresis, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropathic PainOther
Neuropathic pain degrees of the patients will be evaluated with the Douleur Neuropathic-4 (DN4) questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Multiple sclerosis. | Those diagnosed with Multiple Sclerosis according to the 2017 Revised McDonald criteria Receives: Other: Neuropathic Pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropathic pain assessed by Douleur Neuropathic-4 (DN-4) questionnaire.
The patients will be evaluated for neuropathic pain with the Douleur Neuropathic-4 (DN-4) questionnaire. This questionnaire consists of 10 items grouped into four questions: seven items relating to the pain description and to its associated abnormal sensations, and the other three items relating to a brief bedside examination in the painful area. For scoring, 1 is given to each positive and 0 to each negative item. The cut-off value for diagnosis of neuropathic pain is a total score of 4.
Measured: 7 days
Urinary and bowel incotinance assessed by the Functional Independence Measure.
The patients will be evaluated for urinary and bowel incotinance with the sphincter control item of the Functional Independence Measure. Each of the items is graded on a scale of 1-7 based on level of independence in that item (1 = total assistance required, 7 = complete independence).
Measured: 7 days
Disability in multiple sclerosis assessed by the Kurtzke Expanded Disability Status Scale
The patients will be evaluated for disability in multiple sclerosis with The Kurtzke Expanded Disability Status Scale.This scale provides a total score on a scale that ranges from 0 to 10. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refer to the loss of ambulatory ability.
Measured: 3 months
Performance in activities of daily living assessed by the Barthel Index.
The patients will be evaluated for performance in activities of daily living with The Barthel Index. The index consists of 10 items that relate to activities of daily living and is calculated by summing the response value to each of these items. The index provides a total score on a scale that ranges from 0 to 100. The Index yields a total score out of 100 - the higher the score, the greater the degree of functional independence.
Measured: 3 months
Health status assessed by Monitoring My Multiple Sclerosis.
The patients with multiple sclerosis will be evaluated for health status with Monitoring My Multiple Sclerosis. This scale consists of 26 items. Answers are evaluated as 1-4 points. The lowest score that can be obtained from the scale is 26, the highest score is 104, and the highest score indicates the satisfaction of the patients with their condition and functions.
Measured: 3 months
The levels of anxiety and depression assessed by Hospital Anxiety and Depression Scale.
The patients will be evaluated for anxiety and depression with Hospital Anxiety and Depression Scale. The scale is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression.
Measured: 7 days
Sleep quality assessed by Pittsburgh Sleep Quality Index.
The patients will be evaluated for sleep quality with the Pittsburgh Sleep Quality Index. It contains 19 self-reported items and 5 items to be completed by a bed partner or roommate, if possible. Scores range from 0 to 3, and are summed to obtain a global score, which ranges from 0 to 21. Higher scores denote greater sleep disturbance.
Measured: 1 month
Secondary outcomes (1)
Descriptive information
The patient's date of birth, gender, education level, body mass index, occupation, marital status, socioeconomic status, who they live with, the onset of their complaints about the disease, the time of diagnosis of multiple sclerosis (MS), the type of MS, the presence of any pain and the type of pain will be recorded.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start15 Apr 2022
- Primary completion15 Nov 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alper mengi, Istanbul University - Cerrahpasa
- Investigators
- Uğur Uygunoğlu, MD, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374811
- Sponsor's protocol ID
- 26.04.2022/371780
- Status last verified
- Sep 2023
- First submitted
- 9 May 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Neuropathic Pain With Incontinence, Functional Disability and Quality of Life in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05374811
- Acronym / sponsor ID
- 26.04.2022/371780
- Conditions
- Multiple Sclerosis, Disabilities Multiple, Quality of Life, Incontinence, Urinary, Incontinence Bowel, Neuropathic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 16 May 2022 (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 aim of this study to evaluate the relationship of neuropathic pain with urinary and bowel incontinence, functional disability and quality of life in patients with multiple sclerosis.
Detailed description
The patient's date of birth, gender, education level, body mass index, occupation, marital status, socioeconomic status, who they live with, the onset of their complaints about the disease, the time of diagnosis of multiple sclerosis (MS), the type of MS, the presence of any pain and the type of pain will be recorded.
Then, while the patients will be evaluated by researcher Dr Alper Mengi in terms of neuropathic pain, incotinance, disability and independence in activities of daily living. The forms to be used in terms of health perceptions and quality of life, anxiety and depression, and sleep quality will be filled by the patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple sclerosis. | – | Other: Neuropathic PainThose diagnosed with Multiple Sclerosis according to the 2017 Revised McDonald criteria |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It will consist of patients who applied to the Istanbul University Cerrahpaşa Neurology Multiple sclerosis outpatient clinic between the dates of the study.
Key inclusion criteria (3 listed)
- Being diagnosed with MS according to the 2017 Revised McDonald criteria
- Being between the ages of 18-65
- Being in remission (no progression in attacks or disability in the last 3 months).
Key exclusion criteria (7 listed)
- Having another known neurological disease
- Having been diagnosed with a psychiatric disease such as depression, anxiety, bipolar disorder
- Having a history of infectious, chronic inflammatory disease, malignancy
- Having cardiac pathology such as heart failure, coronary artery disease
- Diabetes, chronic kidney failure, chronic liver failure
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 |
|---|---|---|
| Neuropathic PainNeuropathic pain degrees of the patients will be evaluated with the Douleur Neuropathic-4 (DN4) questionnaire. | Other | Multiple sclerosis. |
Primary outcome
Neuropathic pain assessed by Douleur Neuropathic-4 (DN-4) questionnaire.
Time frame: 7 days
The patients will be evaluated for neuropathic pain with the Douleur Neuropathic-4 (DN-4) questionnaire. This questionnaire consists of 10 items grouped into four questions: seven items relating to the pain description and to its associated abnormal sensations, and the other three items relating to a brief bedside examination in the painful area. For scoring, 1 is given to each positive and 0 to each negative item. The cut-off value for diagnosis of neuropathic pain is a total score of 4.
Urinary and bowel incotinance assessed by the Functional Independence Measure.
Time frame: 7 days
The patients will be evaluated for urinary and bowel incotinance with the sphincter control item of the Functional Independence Measure. Each of the items is graded on a scale of 1-7 based on level of independence in that item (1 = total assistance required, 7 = complete independence).
Disability in multiple sclerosis assessed by the Kurtzke Expanded Disability Status Scale
Time frame: 3 months
The patients will be evaluated for disability in multiple sclerosis with The Kurtzke Expanded Disability Status Scale.This scale provides a total score on a scale that ranges from 0 to 10. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refer to the loss of ambulatory ability.
Performance in activities of daily living assessed by the Barthel Index.
Time frame: 3 months
The patients will be evaluated for performance in activities of daily living with The Barthel Index. The index consists of 10 items that relate to activities of daily living and is calculated by summing the response value to each of these items. The index provides a total score on a scale that ranges from 0 to 100. The Index yields a total score out of 100 - the higher the score, the greater the degree of functional independence.
Health status assessed by Monitoring My Multiple Sclerosis.
Time frame: 3 months
The patients with multiple sclerosis will be evaluated for health status with Monitoring My Multiple Sclerosis. This scale consists of 26 items. Answers are evaluated as 1-4 points. The lowest score that can be obtained from the scale is 26, the highest score is 104, and the highest score indicates the satisfaction of the patients with their condition and functions.
The levels of anxiety and depression assessed by Hospital Anxiety and Depression Scale.
Time frame: 7 days
The patients will be evaluated for anxiety and depression with Hospital Anxiety and Depression Scale. The scale is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression.
Sleep quality assessed by Pittsburgh Sleep Quality Index.
Time frame: 1 month
The patients will be evaluated for sleep quality with the Pittsburgh Sleep Quality Index. It contains 19 self-reported items and 5 items to be completed by a bed partner or roommate, if possible. Scores range from 0 to 3, and are summed to obtain a global score, which ranges from 0 to 21. Higher scores denote greater sleep disturbance.
1 secondary outcome
Descriptive information
Time frame: 3 months
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 28 Sep 2023.
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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.
Uğur Uygunoğlu, MD study director
Istanbul University - Cerrahpasa
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 Multiple Sclerosis and Disabilities Multiple, run by Istanbul University - Cerrahpasa 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 3 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 28 Sep 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?
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?
Neuropathic pain assessed by Douleur Neuropathic-4 (DN-4) questionnaire. (time frame: 7 days). The study lists 7 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 28 Sep 2023.