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

NCT05374811 | Completed

• 1 other identifier: 26.04.2022/371780
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Disabilities Multiple; Quality of Life; Incontinence, Urinary; Incontinence Bowel; Neuropathic Pain

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (1)

• Descriptive information

  3 months

Study Arms (1)

Multiple sclerosis.

Those diagnosed with Multiple Sclerosis according to the 2017 Revised McDonald criteria

Other: Neuropathic Pain

Interventions

Neuropathic Pain OTHER

Neuropathic pain degrees of the patients will be evaluated with the Douleur Neuropathic-4 (DN4) questionnaire.

Multiple sclerosis.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University- Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis; Urinary Incontinence; Encopresis; Neuralgia

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations

Study Officials

• Uğur Uygunoğlu, MD

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 16, 2022
• Study Start: April 15, 2022
• Primary Completion: November 15, 2022
• Study Completion: November 15, 2022
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

TU (1)