Marine Lipids Ease Painful TMD

Официальное название

Safety And Analgesic Efficacy of Marine Lipid Precursors of Specialized Pro-Resolving Mediators in Adults With Chronic Temporomandibular Pain

Обзор

The ADAPT study is a single-site, Phase 2b, randomized, quadruple-masked, placebo-controlled trial evaluating an omega-3 dietary supplement enriched with specialized pro-resolving mediator (SPM) precursors in adults with chronic temporomandibular disorder (TMD) pain. The trial will enroll 100 adults aged 18 years or older with examiner-confirmed TMD myalgia or arthralgia will be enrolled at the University of North Carolina at Chapel Hill, Adams School of Dentistry. Participants are randomized 1:1 to receive either the SPM precursor supplement or a matched placebo daily for 8 weeks. Randomization is stratified by sex, and study agents are identical in appearance to maintain masking. The study aims to evaluate whether the SPM precursor supplement: Reduces facial pain intensity compared with placebo. Changes pressure pain sensitivity at the jaw and other standard body sites. Affects other aspects of chronic pain, including duration, interference with daily activities, headache burden, anxiety, depression, jaw-related quality of life, and overall patient-reported change. Participants will record their daily facial pain intensity in electronic diaries, complete short questionnaires at baseline, Week 4, and Week 8, and undergo experimental pain testing with a handheld algometer at baseline, Week 4, and Week 8. Safety is monitored through the documentation of all adverse events throughout the study period.

Подробное описание

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.

Вмешательства

• Пищевая добавка SPM Precursor-Enriched Marine Lipid Supplement
  Participants receive omega-3 SPM precursor-enriched marine lipid softgels administered daily for 8 weeks at the dose specified in the protocol.
• Пищевая добавка Medium-Chain Triglyceride Supplement
  Participants receive matched placebo softgels daily for 8 weeks.

Первичные конечные точки

• Change in average weekly facial pain intensity [Срок оценки: Baseline (week prior to randomization) through Week 8 (final visit, Day 56 ±7)]
• Rate of treatment-emergent adverse events [Срок оценки: From first dose (Visit 1/Randomization, Day 0) through 7 days after the final dose (Visit 3, Day 56 ±7)]

Вторичные конечные точки (9)

• Change in TMD pain duration [Срок оценки: From Visit 1 (Randomization, Day 0) through 7 days after the final dose (Visit 3, Day 56 ±7)]
• Change in TMD pain intensity and pain interference [Срок оценки: Visit 1 (Randomization, Day 0) to Visit 3 (Final visit, Day 56 ±7)]
• Change in headache impact [Срок оценки: Visit 1 (Randomization, Day 0); Visit 2 (Mid-study visit, Day 28 ±7); Visit 3 (Final visit, Day 56 ±7)]
• Change in number of painful body sites [Срок оценки: Visit 1 (Randomization, Day 0); Visit 3 (Final visit, Day 56 ±7)]
• Change in pressure pain thresholds [Срок оценки: Visit 0 (Screening/Baseline, 7-21 days before Visit 1), Visit 3 (Final visit, Day 56 ±7)]
• Change in state anxiety [Срок оценки: Visit 1 (Randomization, Day 0); Visit 3 (Final visit, Day 56 ±7)]
• Change in depression [Срок оценки: Visit 1 (Randomization, Day 0); Visit 3 (Final visit, Day 56 ±7)]
• Change in TMD-related quality of life [Срок оценки: Visit 1 (Randomization, Day 0); Visit 3 (Final visit, Day 56 ±7)]
• Change in overall status [Срок оценки: Visit 2 (Mid-study, Day 28 ±7); Visit 3 (Final visit, Day 56 ±7)]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of North Carolina at Chapel Hill — Chapel Hill

Идентификаторы

NCT: NCT07437313 · 25-0878

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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