Orofacial Pain in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Orofacial Pain in Multiple Sclerosis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT06021561
• Other study ID #: 21062023
• Status: Withdrawn
• Start date: September 4, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2023
• Source: Varazdin General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• multiple scerosis
• age 18-85 years

Exclusion Criteria:

• records with missing data

Related Conditions & MeSH terms

• Facial Pain
• Multiple Sclerosis
• Sclerosis

Intervention

Diagnostic Test:
• Diagnosis of pain
Pain will be investigated - type, origin, level

Locations

Country	Name	City	State
Croatia	Varazdin General Hospital	Varaždin

Sponsors (1)

Lead Sponsor	Collaborator
Varazdin General Hospital

Country where clinical trial is conducted

Croatia, 

References & Publications (14)

Danesh-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. — View Citation

Di 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. — View Citation

Fallata 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. — View Citation

Foley 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. — View Citation

Hadjimichael 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. — View Citation

Hirsh 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. — View Citation

Kahraman 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. — View Citation

Kister 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. — View Citation

Labuz-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. — View Citation

Mazhari 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. — View Citation

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. — View Citation

Solaro 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. — View Citation

Young 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. — View Citation

Zhang 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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

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