The Relationship of Neuropathic Pain With Incontinence, Disability and Life Quality in Multiple Sclerosis Patients

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Multiple Sclerosis; Neuropathic Pain; Incontinence, Urinary; Disabilities Multiple; Incontinence Bowel
• Intervention / Treatment: Other: Neuropathic Pain

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 Type: Observational
• Enrollment (Actual): 175

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul University- Cerrahpasa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Multiple sclerosis.; Those diagnosed with Multiple Sclerosis according to the 2017 Revised McDonald criteria	Other: Neuropathic Pain; Neuropathic pain degrees of the patients will be evaluated with the Douleur Neuropathic-4 (DN4) questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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.	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.	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.	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.	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.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa (IUC)
• Investigators: Study Director: Uğur Uygunoğlu, MD, Istanbul University - Cerrahpasa (IUC)

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2022
• Primary Completion (Actual): November 15, 2022
• Study Completion (Actual): November 15, 2022

Study Registration Dates

• First Submitted: May 9, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 16, 2022

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Digestive System Diseases; Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Pain; Neurologic Manifestations; Gastrointestinal Diseases; Neuromuscular Diseases; Urination Disorders; Peripheral Nervous System Diseases; Intestinal Diseases; Rectal Diseases; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Multiple Sclerosis; Sclerosis; Urinary Incontinence; Neuralgia; Enuresis; Fecal Incontinence
• Other Study ID Numbers: 26.04.2022/371780

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No