Clinical trial NCT06021561: Orofacial Pain in Multiple Sclerosis
Official title: Orofacial Pain in Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Multiple Sclerosis
Keywords: facial pain
craniofacial pain
multiple sclerosis
Lead sponsor: Varazdin General Hospital
Sponsor class: OTHER
First posted: 2023-09-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

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.

Eligibility criteria: Inclusion Criteria:

* multiple scerosis
* age 18-85 years

Exclusion Criteria:

* records with missing data

Primary outcomes:
measure: The frequency of orofacial pain in patients with multiple sclerosis
timeFrame: 3 months
measure: The location of orofacial pain in patients with multiple sclerosis
timeFrame: 3 months
measure: The duration of orofacial pain in patients with multiple sclerosis
timeFrame: 3 months
Secondary outcomes:
measure: MS therapy's influence to pain
timeFrame: 3 months
measure: MS orofacial pain and the duration of the disease
timeFrame: 3 months
measure: Pain and patients' characteristics
timeFrame: 3 months
measure: Other chronic diseases and orofacial pain
timeFrame: 3 months
measure: Pain and daily functioning
timeFrame: 3 months
Other outcomes:
Locations:
city: Varaždin
country: Croatia
facility: Varazdin General Hospital
Study officials:
affiliation: Varazdin General Hospital, Varazdin, Croatia
name: Monika Kocman Panic, MD
role: PRINCIPAL_INVESTIGATOR
References:
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