- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04104906
Motor Control Training in Individuals With Subacromial Pain Syndrome
Motor Control Training in Individuals With Subacromial Pain Syndrome: Randomized Controlled Trial
연구 개요
상세 설명
Methods: This is a randomized controlled trial which will be composed of volunteers of both genders, aged between 35 and 60 years. All volunteers will undergo pre-assessment (Av1): pain sensation, pain and function, shoulder range of motion, muscle strength, electromyographic activity and kinematics of the shoulder complex. After the initial evaluation, the volunteers will be randomly divided into two groups to carry out the intervention: exercises (GE - conventional exercises with elastic band) and motor control (GCM - motor control training). The intervention protocol will last eight weeks. After four weeks, the second assessment (AV2), similar to AV1, will be performed and the global change perception questionnaire will be added. At the end of the intervention protocol, the third evaluation (AV3), similar to AV2, will be performed. A follow-up will be performed after 4 weeks of the end of the intervention protocol, with the assessment being equal to AV3.
The project will be submitted to the Research Ethics Committee of the Federal University of Rio Grande do Norte through the national interface "Plataforma Brasil". The study will also be registered on the international clinical trial platform, ClinicalTrials.gov. The study will only begin after approval of the ethics and research committee. All volunteers should read and sign the terms of free and informed consent.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
RN
-
Natal, RN, 브라질, 59140-840
- Jamilson S Brasileiro
-
Parnamirim, RN, 브라질, 59152820
- Karinna Sonálya Aires da Costa
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Present subacromial pain with a score greater than or equal to 2 (Visual Analog Scale) for more than 2 months;
- Positive Neer test;
- Positive Hawkins test;
- Positive Jobe test (pain);
- Positive Patte test (pain);
- Involvement of the supraspinatus and / or infraspinatus tendon (without degenerative characteristics) confirmed by Magnetic Nuclear Resonance (MRI) examination.
Exclusion Criteria:
- Intense pain during the evaluations;
- Fail to properly perform the evaluation procedures;
- Two consecutive or five alternating absences during the training protocol.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: motor control training
8-week exercise program, twice a week, with motor control training
|
The volunteers of the motor control group will initiate the exercises on a stable and rigid basis.
These will be progressed with adding an unstable base as the volunteer gains motor learning (between the fourth and fifth week of the protocol).
For the motor control group, two sets of 10 repetitions will be performed keeping in isometry for ten seconds each repetition.
|
|
활성 비교기: exercises
8-week exercise program, twice a week.
|
the protocol of strengthening and will have five elastic bands with different resistances available (extra-light, light, moderate, strong and extra-strong) for elbow flexion exercises progression, medial rotation and lateral rotation of the shoulder and scapular retraction.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Shoulder pain
기간: Change from baseline in shoulder pain at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
|
Evaluation of pain level in the shoulder using the Numerical Pain Scale, graded from 0 to 10, where 0 indicates absence of pain and 10 indicates the worst pain imaginable.
|
Change from baseline in shoulder pain at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
|
|
어깨 기능
기간: 개입 프로토콜 후 4주, 8주 및 4주 추적에서 어깨 기능의 기준선에서 변화
|
Disabilities of the Arm, Shoulder and Hand(DASH)를 이용한 어깨 통증 및 기능 평가.
설문지는 자체 평가한 상지 장애 및 증상의 측정으로 개발된 자체 관리 지역별 결과 도구입니다.
DASH는 주로 30개 항목의 장애/증상 척도로 구성되며 0(장애 없음)에서 100까지 점수가 매겨집니다.
점수가 높을수록 기능 장애가 큰 것입니다.
|
개입 프로토콜 후 4주, 8주 및 4주 추적에서 어깨 기능의 기준선에서 변화
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Root Mean Square (RMS)
기간: Change from baseline in RMS at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
|
Analyze of the electromyographic activity of the muscles shoulder complex, after 4 and 8 weeks of the protocol and a follow up of 4 weeks after the intervention protocol, by Root Mean Square (RMS)
|
Change from baseline in RMS at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
|
|
The kinematics of the scapula
기간: Change from baseline in kinematics of the scapular girdle at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
|
Analyze the kinematics of the scapula and glenohumeral in the slow and habitual movements after 8 weeks of the protocol and a follow up of 4 weeks.
|
Change from baseline in kinematics of the scapular girdle at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
|
|
Peak of muscular torque
기간: Change from baseline in peak of muscular torque at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
|
Evaluate the peak of muscular torque, by means of the manual dynamometer 8 weeks of the protocol and a follow up of 4 weeks.
|
Change from baseline in peak of muscular torque at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
|
|
Peak torque time
기간: Change from baseline in peak torque time at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
|
Evaluate the peak torque time, using the manual dynamometer 8 weeks of the protocol and a follow up of 4 weeks.
|
Change from baseline in peak torque time at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
|
|
Range of motion
기간: Change from baseline in range of motion at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
|
Measure the range of motion for flexion, hyperextension, internal and external shoulder rotation 8 weeks of protocol and a follow up of 4 weeks, through the inclinometer.
|
Change from baseline in range of motion at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
어깨 통증에 대한 임상 시험
-
University Hospital, Angers모병
-
Bingol UniversityAtaturk University아직 모집하지 않음수술 전 불안 | 두려움 | PAIN
-
Weill Medical College of Cornell UniversityNew York University; National Center for Complementary and Integrative Health (NCCIH)모병
-
Istanbul University모병Masticatory Muscle Pain | 근시 통증 증후군 (MP)칠면조
-
Istanbul University모병이갈이 | 근막 통증 증후군 | Masticatory Muscle Pain | 현지 근육통터키 (Türkiye)
motor control training에 대한 임상 시험
-
Queens College, The City University of New York완전한
-
Cairo University모병CP(뇌성마비) | 오로 모터 | Mnri | 오메 | Masgutova 방법이집트
-
King's College LondonUniversity College, London; Brighton & Sussex Medical School완전한
-
MMSx Authority Institute for Movement Mechanics...완전한
-
Russell L. WoodsResearch to Prevent Blindness / Lions Club International Foundation아직 모집하지 않음