Clinical trial NCT05374811: The Relationship of Neuropathic Pain With Incontinence, Disability and Life Quality in Multiple Sclerosis Patients
Official title: The Relationship of Neuropathic Pain With Incontinence, Functional Disability and Quality of Life in Patients With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Disabilities Multiple
Quality of Life
Incontinence, Urinary
Incontinence Bowel
Neuropathic Pain
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-05-16
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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

Primary outcomes:
measure: Neuropathic pain assessed by Douleur Neuropathic-4 (DN-4) questionnaire.
timeFrame: 7 days
measure: Urinary and bowel incotinance assessed by the Functional Independence Measure.
timeFrame: 7 days
measure: Disability in multiple sclerosis assessed by the Kurtzke Expanded Disability Status Scale
timeFrame: 3 months
measure: Performance in activities of daily living assessed by the Barthel Index.
timeFrame: 3 months
measure: Health status assessed by Monitoring My Multiple Sclerosis.
timeFrame: 3 months
measure: The levels of anxiety and depression assessed by Hospital Anxiety and Depression Scale.
timeFrame: 7 days
measure: Sleep quality assessed by Pittsburgh Sleep Quality Index.
timeFrame: 1 month
Secondary outcomes:
measure: Descriptive information
timeFrame: 3 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University- Cerrahpasa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Uğur Uygunoğlu, MD
role: STUDY_DIRECTOR
References: