Ultrasounds Evaluation of Asymptomatic Perimandibular Muscles Treated With Dry Needling
2020년 10월 12일 업데이트: Alice Botticchio, Poliambulatorio Physio Power
Morphological Changes in Asymptomatic Perimandibular Muscles After Dry Needling Assessed With Rehabilitative Ultrasound Imaging
The articular disc of temporomandibular joint and three muscles of the cervico-facial region (temporal, masseter, sternocleidomastoid) are evaluated by means of sonographic images to observe and measure their dimensions' changes after a dry needling intervention.
The participants are asymptomatic subjects and will be randomly divided in 2 groups: half of them are treated on the right side of the face, while the other half on the left side.
Our hypothesis is that ultrasonography can reveal changes in the structures measured on the treated side.
연구 개요
상세 설명
The trial is designed as a before-and-after study conducted on asymptomatic subjects. The aim is to assess temporomandibular joint and three perimandibular muscles (temporal, masseter, sternocleidomastoid) by means of rehabilitative ultrasound imaging, carried out by a novice clinician. These evaluations are performed before and after a dry needling treatment directed to the tree studied muscles of one side of the face. The side to be treated is randomly assigned by using a computer-generated randomization process, the other side is used as control.
One month after the treatment sonographic images are taken by the novice clinician and by an expert one. The aim is to assess the reliability of ultrasonography comparing the results of their assessments.
연구 유형
중재적
등록 (실제)
17
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Madrid
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Pozuelo De Alarcón, Madrid, 스페인, 28223
- Universidad Francisco de Vitoria
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Age major then 18 years
- Must be asymptomatic in the face/head region at the time of the visit and in the previous 6 months.
Exclusion Criteria:
- Pregnancy
- medical history of systemic disease
- current pharmacological therapy
- history of recurrent headache and/or neck pain
- presence of orofacial pain or temporomandibular symptoms assessed with the DC/TMD (Diagnostic Criteria for TemporoMandibular Disorders)
- current use of a bite during sleep
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: dry needling group
Dry needling treatment on right or left side of the face (depending on randomization)
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The use of filiform needles to stimulate muscles and connective tissues.
The needle is inserted in a direction perpendicular to the skin, a local twitch response is looked for and, once found, the needle is kept in the muscle without moving for 10 seconds.
No substances are injected.
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간섭 없음: control group
No treatment on left or right side of the face (depending on randomization)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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mean of temporomandibular joint disc thickness
기간: Baseline (before the treatment), immediately after the treatment, one month after the treatment
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the distance between the opposing surfaces of the disc (cm)
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Baseline (before the treatment), immediately after the treatment, one month after the treatment
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mean of temporal muscle thickness
기간: Baseline (before the treatment), immediately after the treatment, one month after the treatment
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the distance between the opposing borders of the muscle, along the transverse axis of the muscle (cm)
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Baseline (before the treatment), immediately after the treatment, one month after the treatment
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mean of masseter muscle thickness
기간: Baseline (before the treatment), immediately after the treatment, one month after the treatment
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the distance between the superficial and the deep border of the muscle (cm)
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Baseline (before the treatment), immediately after the treatment, one month after the treatment
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mean of masseter muscle width
기간: Baseline (before the treatment), immediately after the treatment, one month after the treatment
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the distance between the opposing extremities of the muscle along the transverse axis of the muscle (cm)
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Baseline (before the treatment), immediately after the treatment, one month after the treatment
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mean of masseter muscle cross-sectional area
기간: Baseline (before the treatment), immediately after the treatment, one month after the treatment
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the area of the muscle in transversal plan measured after drawing the outline of the muscle in an image obtained with the panoramic view function (cm2)
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Baseline (before the treatment), immediately after the treatment, one month after the treatment
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mean of sternocleidomastoid muscle thickness
기간: Baseline (before the treatment), immediately after the treatment, one month after the treatment
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the distance between the superficial and the deep border of the muscle (cm)
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Baseline (before the treatment), immediately after the treatment, one month after the treatment
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mean of sternocleidomastoid muscle width
기간: Baseline (before the treatment), immediately after the treatment, one month after the treatment
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the distance between the opposing extremities of the muscle along the transverse axis of the muscle (cm)
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Baseline (before the treatment), immediately after the treatment, one month after the treatment
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mean of sternocleidomastoid muscle cross-sectional area
기간: Baseline (before the treatment), immediately after the treatment, one month after the treatment
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the area of the muscle in transversal plan measured after drawing the outline of the muscle in an image obtained with the panoramic view function (cm2)
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Baseline (before the treatment), immediately after the treatment, one month after the treatment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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mean of maximum mouth opening
기간: Baseline (before the treatment), one month after the treatment
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the distance between the superior border of inferior front teeth and the inferior border of superior front teeth (cm)
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Baseline (before the treatment), one month after the treatment
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Alice Botticchio, PT, OMPT, Poliambulatorio PhysioPower, Brescia, Italy
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2020년 1월 6일
기본 완료 (실제)
2020년 2월 20일
연구 완료 (실제)
2020년 2월 20일
연구 등록 날짜
최초 제출
2020년 10월 1일
QC 기준을 충족하는 최초 제출
2020년 10월 6일
처음 게시됨 (실제)
2020년 10월 8일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 10월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 10월 12일
마지막으로 확인됨
2020년 10월 1일
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니
IPD 계획 설명
We are not intentioned to share the participant data as our outcomes are subjectively evaluated by the use of ultrasonography.
We don't believe it will be helpful for other researches as the results will be interpreted by our assessors.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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