Orofacial Pain in Multiple Sclerosis

April 6, 2024 updated by: Varazdin General Hospital
Although the orofacial pain is not typical symptom of multiple sclerosis, more than 50% of the patients experience some kind of pain. Acute pain usually in form of trigeminal neuralgia, that occurred in 2-3% of patients with multiple sclerosis. Chronic pain occurred in 40-50% of patients and most common forms are headache. Aim of this study is to investigate prevalence and evaluate the form of orofacial pain in patients with multiple sclerosis treated in General hospital Varaždin in period from 01.01. 2017. to 31.12.2022. Results of this investigation will determine better understanding orofacial pain , treatment and impact on everyday life.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Multiple sclerosis is a chronic autoimmune disease with an unknown mechanism of origin. Although pain is not a typical symptom of multiple sclerosis, it occurs in more than 50% of patients and has significant impact on the quality of life of patients. Pain syndromes that patients with multiple sclerosis initially have characteristics of somatic and nociceptive pain, and later neuropathic, including trigeminal neuralgia, headaches, Lhermitte's syndrome.

Pain is also often associated with anxiety and depression, which occurs in almost one third of patients.

Pain therapy in these patients is a challenge for many doctors involved in the treatment. Many patients do not have adequate pain therapy due to the disproportion between the fear of interaction with other drugs and side effects, and on the other hand the treatment of basic diseases with the aim of controlling the immune response.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Varaždin, Croatia, 42000
        • Varazdin General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Multiple sclerosis patients aged 18-65 years registered in Varazdin General Hospital from 1 January 2017 to 31 December 2022

Description

Inclusion Criteria:

  • multiple scerosis
  • age 18-85 years

Exclusion Criteria:

  • records with missing data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Multiple sclerosis group
Multiple sclerosis patients registered in Varazdin General Hospital from 1 January 2017 - 31 December 2022
Diagnostic test: Diagnosis of pain
Pain will be investigated - type, origin, level

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The frequency of orofacial pain in patients with multiple sclerosis
Time Frame: 3 months
To investigate that, hospital records will be reviewed. Additionally, all of the patients will be approached with the questionnaire investigating the frequency of orofacial pain (expressed in number and proportion of all patients)
3 months
The location of orofacial pain in patients with multiple sclerosis
Time Frame: 3 months
To investigate that, hospital records will be reviewed. Additionally, all of the patients will be approached with the questionnaire investigating the loacation of orofacial pain
3 months
The duration of orofacial pain in patients with multiple sclerosis
Time Frame: 3 months
To investigate that, hospital records will be reviewed. Additionally, all of the patients will be approached with the questionnaire investigating the duration of orofacial pain (in months)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MS therapy's influence to pain
Time Frame: 3 months
To investigate connection between orofacial pain and multiple sclerosis therapy
3 months
MS orofacial pain and the duration of the disease
Time Frame: 3 months
To investigate the connection between orofacial pain and the duration of the disease
3 months
Pain and patients' characteristics
Time Frame: 3 months
To investigate the pain characteristics in relation to age, sex, form of the disease
3 months
Other chronic diseases and orofacial pain
Time Frame: 3 months
To investigate the influence of other chronic diseases on orofacial pain in patients with multiple sclerosis
3 months
Pain and daily functioning
Time Frame: 3 months
To investigate the impact of pain on the daily functioning of patients with multiple sclerosis
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Varazdin General Hospital

Investigators

  • Principal Investigator: Monika Kocman Panic, MD, Varazdin General Hospital, Varazdin, Croatia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2023

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

August 18, 2023

First Submitted That Met QC Criteria

August 29, 2023

First Posted (Actual)

September 1, 2023

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 6, 2024

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21062023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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