Orofacial Pain in Multiple Sclerosis

Sponsor
Varazdin General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06021561
Collaborator
(none)
200
1
3.9
51.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Diagnosis of pain

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 Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Orofacial Pain in Multiple Sclerosis
Actual Study Start Date :
Sep 4, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. The frequency of orofacial pain in patients with multiple sclerosis [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)

  2. The location of orofacial pain in patients with multiple sclerosis [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. The duration of orofacial pain in patients with multiple sclerosis [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)

Secondary Outcome Measures

  1. MS therapy's influence to pain [3 months]

    To investigate connection between orofacial pain and multiple sclerosis therapy

  2. MS orofacial pain and the duration of the disease [3 months]

    To investigate the connection between orofacial pain and the duration of the disease

  3. Pain and patients' characteristics [3 months]

    To investigate the pain characteristics in relation to age, sex, form of the disease

  4. Other chronic diseases and orofacial pain [3 months]

    To investigate the influence of other chronic diseases on orofacial pain in patients with multiple sclerosis

  5. Pain and daily functioning [3 months]

    To investigate the impact of pain on the daily functioning of patients with multiple sclerosis

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • multiple scerosis

  • age 18-85 years

Exclusion Criteria:
  • records with missing data

Contacts and Locations

Locations

Site City State Country Postal Code
1 Varazdin General Hospital Varaždin Croatia 42000

Sponsors and Collaborators

  • Varazdin General Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Varazdin General Hospital
ClinicalTrials.gov Identifier:
NCT06021561
Other Study ID Numbers:
  • 21062023
First Posted:
Sep 1, 2023
Last Update Posted:
Sep 6, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Varazdin General Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 6, 2023