Multiple SclerosisNCT06021561
Orofacial Pain in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Varazdin General Hospital at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Diagnosis of pain
- How many people
- 0 participants
- Where
- 1 siteCroatia
- Study dates
- 4 Sep 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Multiple sclerosis patients aged 18-65 years registered in Varazdin General Hospital from 1 January 2017 to 31 December 2022
Who may be able to join
- multiple scerosis
- age 18-85 years
Who cannot join
- records with missing data
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Diagnosis of pain
- Keywords
- facial pain, craniofacial pain, multiple sclerosis
- Medical subject headings
- Multiple Sclerosis, Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosis of painDiagnostic test
Pain will be investigated - type, origin, level
| Study group | Role | What they receive |
|---|---|---|
| Multiple sclerosis group | Multiple sclerosis patients registered in Varazdin General Hospital from 1 January 2017 - 31 December 2022 Receives: Diagnostic Test: Diagnosis of pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of orofacial pain in patients with multiple sclerosis
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)
Measured: 3 months
The location of orofacial pain in patients with multiple sclerosis
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
Measured: 3 months
The duration of orofacial pain in patients with multiple sclerosis
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)
Measured: 3 months
Secondary outcomes (5)
MS therapy's influence to pain
To investigate connection between orofacial pain and multiple sclerosis therapy
Measured: 3 months
MS orofacial pain and the duration of the disease
To investigate the connection between orofacial pain and the duration of the disease
Measured: 3 months
Pain and patients' characteristics
To investigate the pain characteristics in relation to age, sex, form of the disease
Measured: 3 months
Other chronic diseases and orofacial pain
To investigate the influence of other chronic diseases on orofacial pain in patients with multiple sclerosis
Measured: 3 months
Pain and daily functioning
To investigate the impact of pain on the daily functioning of patients with multiple sclerosis
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start4 Sep 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Why it stopped: the principal investigator changed her mind and gave up from the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Varazdin General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Monika Kocman Panic, MD, Principal investigator, Varazdin General Hospital, Varazdin, Croatia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021561
- Sponsor's protocol ID
- 21062023
- Status last verified
- Aug 2023
- First submitted
- 18 Aug 2023
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Putzki N, Pfriem A, Limmroth V, Yaldizli O, Tettenborn B, Diener HC, Katsarava Z. Prevalence of migraine, tension-type headache and trigeminal neuralgia in multiple sclerosis. Eur J Neurol. 2009 Feb;16(2):262-7. doi: 10.1111/j.1468-1331.2008.02406.x. Epub 2008 Dec 9.
PubMed 19138330Young J, Amatya B, Galea MP, Khan F. Chronic pain in multiple sclerosis: A 10-year longitudinal study. Scand J Pain. 2017 Jul;16:198-203. doi: 10.1016/j.sjpain.2017.04.070. Epub 2017 May 24.
PubMed 28850402Hirsh AT, Turner AP, Ehde DM, Haselkorn JK. Prevalence and impact of pain in multiple sclerosis: physical and psychologic contributors. Arch Phys Med Rehabil. 2009 Apr;90(4):646-51. doi: 10.1016/j.apmr.2008.10.019.
PubMed 19345781Di Stefano G, Maarbjerg S, Truini A. Trigeminal neuralgia secondary to multiple sclerosis: from the clinical picture to the treatment options. J Headache Pain. 2019 Feb 19;20(1):20. doi: 10.1186/s10194-019-0969-0.
PubMed 30782116Kahraman T, Ozdogar AT, Ertekin O, Ozakbas S. Frequency, type, distribution of pain and related factors in persons with multiple sclerosis. Mult Scler Relat Disord. 2019 Feb;28:221-225. doi: 10.1016/j.msard.2019.01.002. Epub 2019 Jan 3.
PubMed 30623861Mazhari A. Multiple Sclerosis-Related Pain Syndromes: An Imaging Update. Curr Pain Headache Rep. 2016 Dec;20(12):63. doi: 10.1007/s11916-016-0594-4.
PubMed 27864731Fallata A, Salter A, Tyry T, Cutter GR, Marrie RA. Trigeminal Neuralgia Commonly Precedes the Diagnosis of Multiple Sclerosis. Int J MS Care. 2017 Sep-Oct;19(5):240-246. doi: 10.7224/1537-2073.2016-065.
PubMed 29070964Danesh-Sani SA, Rahimdoost A, Soltani M, Ghiyasi M, Haghdoost N, Sabzali-Zanjankhah S. Clinical assessment of orofacial manifestations in 500 patients with multiple sclerosis. J Oral Maxillofac Surg. 2013 Feb;71(2):290-4. doi: 10.1016/j.joms.2012.05.008. Epub 2012 Jun 27.
PubMed 22742955Kister I, Caminero AB, Monteith TS, Soliman A, Bacon TE, Bacon JH, Kalina JT, Inglese M, Herbert J, Lipton RB. Migraine is comorbid with multiple sclerosis and associated with a more symptomatic MS course. J Headache Pain. 2010 Oct;11(5):417-25. doi: 10.1007/s10194-010-0237-9. Epub 2010 Jul 13.
PubMed 20625916Zhang GQ, Meng Y. Oral and craniofacial manifestations of multiple sclerosis: implications for the oral health care provider. Eur Rev Med Pharmacol Sci. 2015 Dec;19(23):4610-20.
PubMed 26698259Foley PL, Vesterinen HM, Laird BJ, Sena ES, Colvin LA, Chandran S, MacLeod MR, Fallon MT. Prevalence and natural history of pain in adults with multiple sclerosis: systematic review and meta-analysis. Pain. 2013 May;154(5):632-642. doi: 10.1016/j.pain.2012.12.002. Epub 2012 Dec 14.
PubMed 23318126Solaro C, Brichetto G, Amato MP, Cocco E, Colombo B, D'Aleo G, Gasperini C, Ghezzi A, Martinelli V, Milanese C, Patti F, Trojano M, Verdun E, Mancardi GL; PaIMS Study Group. The prevalence of pain in multiple sclerosis: a multicenter cross-sectional study. Neurology. 2004 Sep 14;63(5):919-21. doi: 10.1212/01.wnl.0000137047.85868.d6.
PubMed 15365151Hadjimichael O, Kerns RD, Rizzo MA, Cutter G, Vollmer T. Persistent pain and uncomfortable sensations in persons with multiple sclerosis. Pain. 2007 Jan;127(1-2):35-41. doi: 10.1016/j.pain.2006.07.015. Epub 2006 Sep 1.
PubMed 16949751Labuz-Roszak B, Niewiadomska E, Kubicka-Baczyk K, Skrzypek M, Tyrpien-Golder K, Majewska A, Matejczyk A, Dobrakowski P, Pierzchala K. Prevalence of pain in patients with multiple sclerosis and its association with anxiety, depressive symptoms and quality of life. Psychiatr Pol. 2019 Apr 30;53(2):475-486. doi: 10.12740/PP/94469. Epub 2019 Apr 30. English, Polish.
PubMed 31317971
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orofacial Pain in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06021561
- Acronym / sponsor ID
- 21062023
- Conditions
- Multiple Sclerosis
- Keywords
- facial pain, craniofacial pain, multiple sclerosis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: the principal investigator changed her mind and gave up from the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Varazdin General HospitalUniversity, hospital or other
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 1 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple sclerosis group | – | Diagnostic Test: Diagnosis of painMultiple sclerosis patients registered in Varazdin General Hospital from 1 January 2017 - 31 December 2022 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Multiple sclerosis patients aged 18-65 years registered in Varazdin General Hospital from 1 January 2017 to 31 December 2022
Key inclusion criteria (2 listed)
- multiple scerosis
- age 18-85 years
Key exclusion criteria (1 listed)
- records with missing data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnosis of painPain will be investigated - type, origin, level | Diagnostic test | Multiple sclerosis group |
Primary outcome
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)
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
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)
5 secondary outcomes
MS therapy's influence to pain
Time frame: 3 months
MS orofacial pain and the duration of the disease
Time frame: 3 months
Pain and patients' characteristics
Time frame: 3 months
Other chronic diseases and orofacial pain
Time frame: 3 months
Pain and daily functioning
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Background: PubMed 19138330Putzki N, Pfriem A, Limmroth V, Yaldizli O, Tettenborn B, Diener HC, Katsarava Z. Prevalence of migraine, tension-type headache and trigeminal neuralgia in multiple sclerosis. Eur J Neurol. 2009 Feb;16(2):262-7. doi: 10.1111/j.1468-1331.2008.02406.x. Epub 2008 Dec 9.
- Background: PubMed 28850402Young J, Amatya B, Galea MP, Khan F. Chronic pain in multiple sclerosis: A 10-year longitudinal study. Scand J Pain. 2017 Jul;16:198-203. doi: 10.1016/j.sjpain.2017.04.070. Epub 2017 May 24.
- Background: PubMed 19345781Hirsh AT, Turner AP, Ehde DM, Haselkorn JK. Prevalence and impact of pain in multiple sclerosis: physical and psychologic contributors. Arch Phys Med Rehabil. 2009 Apr;90(4):646-51. doi: 10.1016/j.apmr.2008.10.019.
- Background: PubMed 30782116Di Stefano G, Maarbjerg S, Truini A. Trigeminal neuralgia secondary to multiple sclerosis: from the clinical picture to the treatment options. J Headache Pain. 2019 Feb 19;20(1):20. doi: 10.1186/s10194-019-0969-0.
- Background: PubMed 30623861Kahraman T, Ozdogar AT, Ertekin O, Ozakbas S. Frequency, type, distribution of pain and related factors in persons with multiple sclerosis. Mult Scler Relat Disord. 2019 Feb;28:221-225. doi: 10.1016/j.msard.2019.01.002. Epub 2019 Jan 3.
- Background: PubMed 27864731Mazhari A. Multiple Sclerosis-Related Pain Syndromes: An Imaging Update. Curr Pain Headache Rep. 2016 Dec;20(12):63. doi: 10.1007/s11916-016-0594-4.
- Background: PubMed 29070964Fallata A, Salter A, Tyry T, Cutter GR, Marrie RA. Trigeminal Neuralgia Commonly Precedes the Diagnosis of Multiple Sclerosis. Int J MS Care. 2017 Sep-Oct;19(5):240-246. doi: 10.7224/1537-2073.2016-065.
- Background: PubMed 22742955Danesh-Sani SA, Rahimdoost A, Soltani M, Ghiyasi M, Haghdoost N, Sabzali-Zanjankhah S. Clinical assessment of orofacial manifestations in 500 patients with multiple sclerosis. J Oral Maxillofac Surg. 2013 Feb;71(2):290-4. doi: 10.1016/j.joms.2012.05.008. Epub 2012 Jun 27.
- Background: PubMed 20625916Kister I, Caminero AB, Monteith TS, Soliman A, Bacon TE, Bacon JH, Kalina JT, Inglese M, Herbert J, Lipton RB. Migraine is comorbid with multiple sclerosis and associated with a more symptomatic MS course. J Headache Pain. 2010 Oct;11(5):417-25. doi: 10.1007/s10194-010-0237-9. Epub 2010 Jul 13.
- Background: PubMed 26698259Zhang GQ, Meng Y. Oral and craniofacial manifestations of multiple sclerosis: implications for the oral health care provider. Eur Rev Med Pharmacol Sci. 2015 Dec;19(23):4610-20.
- Background: PubMed 23318126Foley PL, Vesterinen HM, Laird BJ, Sena ES, Colvin LA, Chandran S, MacLeod MR, Fallon MT. Prevalence and natural history of pain in adults with multiple sclerosis: systematic review and meta-analysis. Pain. 2013 May;154(5):632-642. doi: 10.1016/j.pain.2012.12.002. Epub 2012 Dec 14.
- Background: PubMed 15365151Solaro C, Brichetto G, Amato MP, Cocco E, Colombo B, D'Aleo G, Gasperini C, Ghezzi A, Martinelli V, Milanese C, Patti F, Trojano M, Verdun E, Mancardi GL; PaIMS Study Group. The prevalence of pain in multiple sclerosis: a multicenter cross-sectional study. Neurology. 2004 Sep 14;63(5):919-21. doi: 10.1212/01.wnl.0000137047.85868.d6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monika Kocman Panic, MD principal investigator
Varazdin General Hospital, Varazdin, Croatia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Varazdin General Hospital at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency of orofacial pain in patients with multiple sclerosis (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06021561, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.