Diagnostic and Prognostic Salivary Biomarkers in Chronic Muscle Pain

Active, not recruiting

• Conditions: TMD/Orofacial Pain; Fibromyalgia (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

Study Timeline

• Study Start: 2023-09-01
• Status Verified: 2025-05
• Study First Submitted: 2025-05-20
• Study First Submitted QC: 2025-05-20
• Study First Posted: 2025-05-29
• Last Update Submitted: 2025-05-30
• Last Update Posted: 2025-06-04
• Primary Completion: 2027-04-01
• Study Completion: 2029-01-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

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,

Trial Locations

Locations (1)

Karolinska Institutet, Department of Dental Medicine; 🇸🇪 Stockholm, Huddinge, Sweden