Safety And Analgesic Efficacy of Marine Lipid Precursors of Specialized Pro-Resolving Mediators in Adults With Chronic Temporomandibular Pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in average weekly facial pain intensity
研究概览
简要总结
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 paper 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, care providers, investigators, and outcomes assessors are unaware of group assignment. Active and placebo softgels are identical in appearance and packaging. Randomization codes are maintained by an independent data manager until study completion.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- 未提供
研究组 & 干预措施
SPM precursor marine lipid dietary supplement
Experimental Arm - SPM Precursor Marine Lipid Supplement: Participants receive 2 g/day (1 g twice daily) of SPM Active® softgels containing 18-HEPE, 17-HDHA, and 14-HDHA. Softgels are identical in appearance to placebo. Duration: 8 weeks.
Placebo Arm - Medium-Chain Triglyceride (MCT) Supplement: Participants receive 2 g/day (1 g twice daily) of MCT oil softgels, identical in appearance to active supplement. Duration: 8 weeks.
干预措施: SPM Precursor-Enriched Marine Lipid Supplement (Dietary Supplement)
Medium-chain triglyceride dietary supplement
Participants receive 2 grams per day of a placebo supplement, administered as medium-chain triglyceride (MCT) oil softgels. Participants take 1 gram orally twice daily for 8 weeks. The placebo softgels are identical in appearance and packaging to the active supplement. Participants remain in this arm for the full duration of the study.
干预措施: Medium-Chain Triglyceride Supplement (Dietary Supplement)
结局指标
主要结局
Change in average weekly facial pain intensity
时间窗: Baseline (week prior to randomization) through Week 8 (final visit, Day 56 ±7)
Net change from baseline to Week 8 in average weekly facial pain intensity, calculated as the mean of daily entries recorded in the Daily Symptom Diary (DSD). Higher scores indicate worse pain.
Rate of treatment-emergent adverse events
时间窗: From first dose (Visit 1/Randomization, Day 0) through 7 days after the final dose (Visit 3, Day 56 ±7)
Rate of participants experiencing any adverse event (AE) that first appears or worsens after starting the study intervention and up to 7 days after the last dose. Investigators record onset, duration, severity, and relatedness to the study intervention. This measure evaluates the safety of the SPM precursor marine lipid supplement compared with placebo.
次要结局
- Change in TMD pain duration(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(Visit 1 (Randomization, Day 0) to Visit 3 (Final visit, Day 56 ±7))
- Change in headache impact(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(Visit 1 (Randomization, Day 0); Visit 3 (Final visit, Day 56 ±7))
- Change in pressure pain thresholds(Visit 0 (Screening/Baseline, 7-21 days before Visit 1), Visit 3 (Final visit, Day 56 ±7))
- Change in state anxiety(Visit 1 (Randomization, Day 0); Visit 3 (Final visit, Day 56 ±7))
- Change in depression(Visit 1 (Randomization, Day 0); Visit 3 (Final visit, Day 56 ±7))
- Change in TMD-related quality of life(Visit 1 (Randomization, Day 0); Visit 3 (Final visit, Day 56 ±7))
- Change in overall status(Visit 2 (Mid-study, Day 28 ±7); Visit 3 (Final visit, Day 56 ±7))