해양 지질이 고통스러운 TMD를 완화합니다 (ADAPT)
만성 측두하악 통증을 가진 성인에서 특수 해결 매개체의 해양 지질 전구체의 안전성 및 진통 효능
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Anne E Sanders, PhD
- 전화번호: (919) 246-5833
- 이메일: adaptsms@adapt.study
연구 연락처 백업
- 이름: Lorraine M King
- 전화번호: (919) 246-5833
- 이메일: adaptsms@adapt.study
연구 장소
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North Carolina
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Chapel Hill, North Carolina, 미국, 27599
- 모병
- University of North Carolina at Chapel Hill
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: 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. |
|
위약 비교기: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in average weekly facial pain intensity
기간: 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)
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Rate of treatment-emergent adverse events
기간: From first dose (Visit 1/Randomization, Day 0) through 7 days after the final dose (Visit 3, Day 56 ±7)
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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)
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in TMD pain duration
기간: From Visit 1 (Randomization, Day 0) through 7 days after the final dose (Visit 3, Day 56 ±7)
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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)
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Change in TMD pain intensity and pain interference
기간: Visit 1 (Randomization, Day 0) to Visit 3 (Final visit, Day 56 ±7)
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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)
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Change in headache impact
기간: Visit 1 (Randomization, Day 0); Visit 2 (Mid-study visit, Day 28 ±7); Visit 3 (Final visit, Day 56 ±7)
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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)
|
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Change in number of painful body sites
기간: Visit 1 (Randomization, Day 0); Visit 3 (Final visit, Day 56 ±7)
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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)
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Change in pressure pain thresholds
기간: Visit 0 (Screening/Baseline, 7-21 days before Visit 1), Visit 3 (Final visit, Day 56 ±7)
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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)
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Change in state anxiety
기간: 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)
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Change in depression
기간: Visit 1 (Randomization, Day 0); Visit 3 (Final visit, Day 56 ±7)
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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)
|
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Change in TMD-related quality of life
기간: 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)
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Change in overall status
기간: Visit 2 (Mid-study, Day 28 ±7); Visit 3 (Final visit, Day 56 ±7)
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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)
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Anne E Sanders, PhD, University of North Carolina, Chapel Hill
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 25-0878
- UG3DE033354 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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 공유 기간
beginning 9 and continuing for 36 months following publication
IPD 공유 액세스 기준
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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