Marine Lipids Ease Painful TMD

Study Overview Participant Procedures Screening/Baseline (Visit 0-1): DC-TMD examination to confirm eligibility; review of medications and health history; baseline questionnaires; pressure pain threshold testing; body manikin pain mapping.

Daily Diaries: Participants record facial pain intensity (0-100 NRS) each day for 8 weeks.

Mid-study Assessment (Week 4, Visit 2): Questionnaires for pain, mood, quality of life; pressure pain threshold testing.

Final Visit (Week 8, Visit 3): Repeat questionnaires, pressure pain testing, and body manikin assessments; blood collection for polyunsaturated fatty acid (PUFA)/oxylipin analysis.

Follow-up Call (1 week post-intervention): Safety check for adverse events.

Study Duration

Total participation: up to 12 weeks (pre-screening, 8-week intervention, 1-week follow-up).

Assessments at baseline, Week 4, Week 8, and follow-up call.

Population and Recruitment Adults ≥18 years with examiner-confirmed TMD myalgia or arthralgia. Participants of all races and ethnicities are eligible; anticipated demographics: ~77% female, 6% Hispanic, 83% White, 8% African American, 9% other.

Overall Goal To provide high-quality evidence on the effects of omega-3 SPM precursors on facial pain, pressure pain sensitivity, psychosocial distress, headache burden, jaw-related quality of life.

Inclusion

Pre-screening (before Visit 0):

• Age ≥18 years.
• Pain in jaws, temples, ears, or in front of ears at least 5 days in the past 30 days, occurring monthly over the last 3 months.
• Pain not due to toothache or ear infection.
• Pain intensity ≥30 on a 0-100 numeric rating scale (NRS) during the week before pre-screening.
• Willing to provide written informed consent and follow all study procedures.
• Able to be contacted reliably during the study period.

Visit 0 - Screening/Baseline:

• Meets all pre-screening criteria above.
• Examiner-confirmed TMD diagnosis (myalgia or arthralgia) per DC-TMD criteria.
• Discontinues omega-3 supplements prior to randomization and agrees not to use them during the study.
• Will not initiate new occlusal splint therapy during the study. Participants already using a splint ≥30 days prior may continue.
• Maintains stable facial pain management regimen:
• No changes to regularly scheduled daily pain medications.
• No initiation of new facial pain treatments (pharmacologic, injectable, or non-pharmacologic).
• Episodic prescription pain medications discontinued prior to randomization, except NSAIDs, acetaminophen, or low-dose aspirin.

Visit 1 - Randomization:

• Completes ≥4 of 7 daily symptom diary (DSD) entries before Visit 1.
• Average weekly pain ≥30 on 0-100 NRS, or ≥30 on at least 4 days that week.

Exclusion (Assessed at pre-screening and/or Visit 0):

• Allergy or hypersensitivity to fish or seafood.
• Botulinum toxin injections for facial pain within past 3 months.
• Facial trauma or orofacial surgery within past 6 weeks.
• History of renal failure or dialysis.
• History of hyperthyroidism.
• Immunocompromised state or autoimmune disorder.
• History of seizure disorder or uncontrolled seizures.
• Use of opioid medications in the past 30 days.
• Pregnancy.