海洋性脂質が痛みを伴うTMDを緩和 (ADAPT)
慢性顎関節痛を有する成人における特殊化された炎症収束性メディエーターの海洋脂質前駆体の安全性と鎮痛効果
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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Anne E Sanders, PhD
- 電話番号：(919) 246-5833
- メール：adaptsms@adapt.study
研究連絡先のバックアップ
- 名前：Lorraine M King
- 電話番号：(919) 246-5833
- メール：adaptsms@adapt.study
研究場所
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-
North Carolina
-
Chapel Hill、North Carolina、アメリカ、27599
- 募集
- University of North Carolina at Chapel Hill
-
-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：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. |
Participants receive omega-3 SPM precursor-enriched marine lipid softgels administered daily for 8 weeks at the dose specified in the protocol. |
|
プラセボコンパレーター：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. |
Participants receive matched placebo softgels daily for 8 weeks. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in average weekly facial pain intensity
時間枠：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. |
Baseline (week prior to randomization) through Week 8 (final visit, Day 56 ±7)
|
|
Rate of treatment-emergent adverse events
時間枠：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. |
From first dose (Visit 1/Randomization, Day 0) through 7 days after the final dose (Visit 3, Day 56 ±7)
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in TMD pain duration
時間枠：From Visit 1 (Randomization, Day 0) through 7 days after the final dose (Visit 3, Day 56 ±7)
|
Change from baseline to Week 8 (Visit 3) in the percentage of waking time with facial pain, expressed in percentage points, based on daily diary entries (0-100 scale). |
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
時間枠：Visit 1 (Randomization, Day 0) to Visit 3 (Final visit, Day 56 ±7)
|
Change from baseline to Week 8 (Visit 3) in TMD pain intensity (current, worst, and average) and interference with daily activities. Assessed using the Graded Chronic Pain Scale (0-10 scale), with higher scores indicating worse pain and greater interference. |
Visit 1 (Randomization, Day 0) to Visit 3 (Final visit, Day 56 ±7)
|
|
Change in headache impact
時間枠：Visit 1 (Randomization, Day 0); Visit 2 (Mid-study visit, Day 28 ±7); Visit 3 (Final visit, Day 56 ±7)
|
Change from baseline to Week 8 (Visit 3) in headache impact measured with the Headache Impact Test-6 (HIT-6). Scores range 36-78, with higher scores indicating greater headache-related 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
時間枠：Visit 1 (Randomization, Day 0); Visit 3 (Final visit, Day 56 ±7)
|
Change from baseline to Week 8 (Visit 3) in the number of anatomical locations marked as painful on anterior and posterior body manikins (range 0-42), with higher scores indicating more widespread pain. |
Visit 1 (Randomization, Day 0); Visit 3 (Final visit, Day 56 ±7)
|
|
Change in pressure pain thresholds
時間枠：Visit 0 (Screening/Baseline, 7-21 days before Visit 1), Visit 3 (Final visit, Day 56 ±7)
|
Change from baseline to Week 8 (Visit 3) in pressure pain thresholds (kg) measured bilaterally at five anatomical sites: temporalis, masseter, TM joint, trapezius, and lateral epicondyle. Up to 5 trials per site are performed until two measurements differ by ≤0.2 kg. Higher numbers indicate lower pain sensitivity. |
Visit 0 (Screening/Baseline, 7-21 days before Visit 1), Visit 3 (Final visit, Day 56 ±7)
|
|
Change in state anxiety
時間枠：Visit 1 (Randomization, Day 0); Visit 3 (Final visit, Day 56 ±7)
|
Change from Day 0 to Week 8 (Visit 3) in state anxiety measured using the State subscale of the State-Trait Anxiety Inventory (range 20-80), with higher scores indicating greater anxiety. |
Visit 1 (Randomization, Day 0); Visit 3 (Final visit, Day 56 ±7)
|
|
Change in depression
時間枠：Visit 1 (Randomization, Day 0); Visit 3 (Final visit, Day 56 ±7)
|
Change from Day 0 to Week 8 (Visit 3) in depressive symptoms measured using the Symptom Checklist-90 (SCL90) Depression subscale (range 0-48), with higher scores indicating more severe symptoms. |
Visit 1 (Randomization, Day 0); Visit 3 (Final visit, Day 56 ±7)
|
|
Change in TMD-related quality of life
時間枠：Visit 1 (Randomization, Day 0); Visit 3 (Final visit, Day 56 ±7)
|
Change from Day 0 to Week 8 (Visit 3) in the impact of TMD on daily activities, pain, psychological well-being, and other aspects of quality of life. Measured with a summary score using the Oral Health Impact Profile-TMD (OHIP-TMD, range 0-88), with higher scores indicating greater adverse impact. |
Visit 1 (Randomization, Day 0); Visit 3 (Final visit, Day 56 ±7)
|
|
Change in overall status
時間枠：Visit 2 (Mid-study, Day 28 ±7); Visit 3 (Final visit, Day 56 ±7)
|
Change at Weeks 4 (Visit 2) and 8 (Visit 3) in participants' perceived change in activities, symptoms, emotions, and quality of life related to facial pain, assessed using the Patient Global Impression of Change questionnaire (7-point scale), with higher scores reflecting greater improvement. |
Visit 2 (Mid-study, Day 28 ±7); Visit 3 (Final visit, Day 56 ±7)
|
協力者と研究者
協力者
協力者
捜査官
捜査官
- 主任研究者：Anne E Sanders, PhD、University of North Carolina, Chapel Hill
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- 25-0878
- UG3DE033354 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
IPD 共有時間枠
beginning 9 and continuing for 36 months following publication
IPD 共有アクセス基準
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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