Diagnostic and Prognostic Salivary Biomarkers in Chronic Muscle Pain
- Conditions
- TMD/Orofacial PainFibromyalgia (FM)
- Registration Number
- NCT06994156
- Lead Sponsor
- Karolinska Institutet
- Brief Summary
A large proportion of the adult population worldwide currently lives with chronic muscle pain, with more than half of those affected experiencing pain localized to the face and jaw. This means that approximately 10-15% of the adult population is affected. Living with chronic muscle pain impacts many aspects of life, significantly affecting both the individual's quality of life and well-being as well as that of their close relations.
As with other chronic pain conditions, researchers agree that multiple factors contribute to the development and aggravation of the condition. The aim of this project is to identify proteins in saliva that are involved in the disease process of chronic muscle pain, in order to better understand the underlying mechanisms, improve prognosis assessment, and ultimately develop more effective treatments.
The project includes patients with localized chronic jaw muscle pain, those with generalized chronic pain (fibromyalgia), and pain-free individuals in a matched control group. Validated questionnaires are used to assess pain, including measures of physical and emotional function, followed by a clinical examination. Chewing-stimulated saliva is selected for sampling based on previous studies from the research group, and blood samples are collected from all participants. Proteins involved in metabolism, stress, and immunity will be analyzed, building on prior research conducted by the group. Patients will undergo conventional orofacial pain treatment and will later be followed up with new samples to study changes in protein expression following successful treatment.
Chronic muscle pain is one of the leading causes of work incapacity and long-term sick leave. This project combines clinical examinations with advanced biomedical analysis methods to investigate the role of specific proteins in disease development. The goal is to identify proteins involved in pain mechanisms to improve diagnostics and enable personalized treatments. In the short term, this could lead to faster and more accurate diagnoses and the development of new treatment strategies, which would reduce pain intensity and work incapacity, ultimately benefiting both individuals and society.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 160
Diagnosis of myalgia or myofascial pain with referral according to the (DC/TMD axis I) or fibromyalgia according to ACR 1990/2016. For all patients, a minimum pain intensity of 30 on a 100 mm visual analogue scale (VAS) is also required.
Exclusion criteria: diagnosed systemic muscular or joint diseases (except for the fibromyalgia); whiplash-associated disorder; migraine; neurological or neuropsychiatric disorders; diseases of salivary glands such as sialadenitis and salivary gland tumours; pregnancy or lactation; obesity; use of analgesics during the last 24 hours; oral complaints, such as oral dryness or mucosal lesions; participants with less than 22 teeth and extensive prosthodontics rehabilitations; and poor oral hygiene, hyposalivation, oral diseases (periodontal diseases and mucosal pain or ulcerations), or extensive dental abrasion
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in salivary protein expression levels 7 months Change in salivary protein expression levels (e.g., inflammation-, stress-, or metabolism-related biomarkers) before and after conventional orofacial pain treatment,
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Karolinska Institutet, Department of Dental Medicine
🇸🇪Stockholm, Huddinge, Sweden