Status:
ACTIVE_NOT_RECRUITING
Diagnostic and Prognostic Salivary Biomarkers in Chronic Muscle Pain
Lead Sponsor:
Karolinska Institutet
Collaborating Sponsors:
Eastmaninstitutet
Conditions:
TMD/Orofacial Pain
Fibromyalgia (FM)
Eligibility:
FEMALE
18-65 years
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 ap...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Diagnosis of myalgia or myofascial pain with referral according to the DC/TMD Axis I
- Diagnosis of fibromyalgia according to ACR 1990 or ACR 2016 criteria
- Minimum pain intensity of 30 on a 100 mm visual analogue scale (VAS)
- Exclusion Criteria
- Diagnosed systemic muscular or joint diseases (except for fibromyalgia)
- Whiplash-associated disorder
- Migraine
- Neurological disorders
- Neuropsychiatric disorders
- Diseases of the salivary glands (e.g., sialadenitis, salivary gland tumours)
- Pregnancy and lactation
- Obesity
- Use of analgesics within the last 24 hours
- Oral complaints such as oral dryness
- Mucosal lesions in the oral cavity
- Fewer than 22 natural teeth
- Extensive prosthodontic rehabilitations
- Poor oral hygiene
- Hyposalivation
- Oral diseases (periodontal diseases and mucosal pain or ulcerations)
- Extensive dental abrasion
Exclusion
Key Trial Info
Start Date :
September 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06994156
Start Date
September 1 2023
End Date
January 1 2029
Last Update
June 4 2025
Active Locations (1)
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1
Karolinska Institutet, Department of Dental Medicine
Stockholm, Huddinge, Sweden, 14152