- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03958227
Investigation The Efficacy of Manual Therapy and Exercise in Patients With Glenohumeral Arthritis
2019년 12월 30일 업데이트: Sibel Gayretli Atan, Istanbul University
Istanbul University, Faculty of Health Science, Division of Physiotherapy and Rehabilitation
The aim of the investigator's study is to compare the efficacy of manual therapy and exercise practices compared to exercise practice in patients with Glenohumeral Arthritis.
Thirty volunteer patients will include into the study.
연구 개요
상세 설명
Patients will randomly divide into two groups.
A common exercise program was applied to both groups during 15 sessions.
Manual therapy techniques will apply to the manual therapy group in addition to exercise practices.
Patients will evaluate in terms of functional status, pain, range of motion, muscle strength and health-related quality before and after 5 weeks of treatment.
Also, patient's satisfaction from treatment will evaluate at the 5th week of the treatment.
DASH and ASES forms for functional status, VAS for pain, digital goniometer for range of motion, manual muscle test for muscle strength, SF-12 for health-related quality of life, and Global Rating of Change (GRC) Scale for patient satisfaction will be used as evaluation criteria.
연구 유형
중재적
등록 (실제)
30
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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Istanbul
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Bakırköy, Istanbul, 칠면조, 34180
- Istanbul University
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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
40년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- 40 years and older patients
- To be diagnosed with GHOA by specialist physician via MRI, US or radiography and physical examination
- Unilateral shoulder pain lasting more than 2 months seen during daily living activities and at rest
Exclusion Criteria:
Patients with:
- Severe arthrosis
- Tumor
- Cervical radiculopathy
- Emotional or cognitive problems
- A neurological disease that causes muscle weakness on the shoulder
- A skin disease that may affect upper extremity assessment.
- Frozen shoulder
- Thoracic outlet syndrome
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: ''Manuel Therapy group''
This treatment group will be received Manuel Therapy techniques and exercise interventions.
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Shoulder mobilization techniques include glenohumeral traction, anterior, posterior and inferior glide.
We will also use anterior, posterior and inferior joint stretching exercises and scapular mobilization.
Exercise interventions include range of motion exercises, stretching exercises, strengthening exercises, and pendulum exercises.
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실험적: ''Exercise group''
This treatment group will be received only exercise interventions.
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Exercise interventions include range of motion exercises, stretching exercises, strengthening exercises, and pendulum exercises.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Shoulder Range of Motion (ROM)
기간: Evaluation will be performed first time at baseline and second time will be performed after 5 weeks rehabilitation program. After treatment "change" will be assessed.
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The shoulder flexion, abduction, internal and external rotation ROM will be evaluated with digital goniometer while the patient will be in supine position.
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Evaluation will be performed first time at baseline and second time will be performed after 5 weeks rehabilitation program. After treatment "change" will be assessed.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
ASES (The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment) Form
기간: Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
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ASES is an assessment form prepared by shoulder and elbow surgeons with objective and subjective sections.
The total score is at least 0 and at most 100, and the high scores are positively correlated with the normal function.
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Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
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Visual Analogue Scale (VAS)
기간: Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
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The levels of pain is felted at rest / activity / night will be measured using Visual Analogue Scale (VAS).Patients will be asked to evaluate their pain status with a 10-point scale and high scores are positively correlated with pain.
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Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
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Manual Muscle Test
기간: Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
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Manual Muscle Test is a procedure for the evaluation of strength of individual muscle or muscles group, based upon the effective performance of a movement in relation to the forces of gravity or manual resistance through the available ROM.
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Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
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Short Form 12 (SF-12)
기간: Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
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SF-12 will be used to assess physical and mental health-related quality of life.
The total score is at least 0 and at most 100, and the high scores are positively correlated with high quality of life.
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Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
|
|
Global Rating of Change (GRC) Scale
기간: Evaluation will be performed after 5 weeks rehabilitation program.
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Global Rating of Change (GRC) scale will be used to assess the overall satisfaction levels of the patients.
Patients will be asked to evaluate their post-treatment status with a 5-point likert scale and high scores are positively correlated with satisfaction.
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Evaluation will be performed after 5 weeks rehabilitation program.
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The Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
기간: Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
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DASH questionnaire inquires about the activities of a person in daily life, the degree of participation in recreational activities, the symptom and psychosocial state that affects their pain, emotional state and sleep quality.
The total score is at least 0 and at most 100, and the high scores are positively correlated with the increased functional impairment.
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Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Sibel Gayretli Atan, sssibel_38@hotmail.com
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)
2019년 5월 20일
기본 완료 (실제)
2019년 11월 29일
연구 완료 (실제)
2019년 12월 30일
연구 등록 날짜
최초 제출
2019년 4월 11일
QC 기준을 충족하는 최초 제출
2019년 5월 20일
처음 게시됨 (실제)
2019년 5월 21일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 1월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 12월 30일
마지막으로 확인됨
2019년 11월 1일
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. .