- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03194490
Benefit of Adding Stretching to Standard Intervention For Patients With Nonspecific Mechanical Neck Pain
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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California
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Loma Linda, California, 미국, 92354
- Loma Linda U
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- The participant will be eligible to participate in the study if he or she is between 18 and 60 years of age, had non-specific neck pain for at least 2 weeks
Exclusion Criteria:
- Participants will be excluded from the study if they had one or more of the following conditions: had previous surgery in cervical spine area, chronic disease such as diabetes, vertigo, dizziness, fracture of the cervical vertebra or scapula, multiple sclerosis, osteoporosis, rheumatoid arthritis or osteoarthritis as approximately 60% of people who aged between 50-60 years will have osteoarthritis.
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 |
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실험적: The combined intervention group
The combined intervention group will receive the cervical passive mobilization, stretching, and home program (Stretching and ROM exercise).
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The combined intervention group received the cervical passive mobilization, stretching, and home program (Stretching and ROM exercise).Stretching, cervical passive mobilization, and range of motion: The manual therapy was conducted by a physical therapist who has licensed from the California Board of Physical Therapy.
The cervical passive mobilization were selected by the physical therapist based on the participant's condition.
Stretching techniques were performed in the combined intervention group for 30 seconds and repeated 3 times twice a week in the following order on the following muscles: anterior, middle and posterior scalene, upper fibers of trapezius, pectoralis minor and interspinous muscles .AROM Exercise were performed 10 repetitions 3-4 times daily.
The ACROM exercise consisted of the subject placing fingers over the manubrium bone and placing chin on the fingers.
The subject was then instructed to rotate to one side as far as possible and return to neutral.
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활성 비교기: The standard intervention
The standard intervention group will receive cervical mobilization and home program (ROM exercises).
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The standard intervention group will receive cervical mobilization and home program (ROM exercises). Cervical mobilization and range of motion: The manual therapy was conducted by a physical therapist who has experience in manual therapy and is licensed from the California Board of Physical Therapy. The manual therapy intervention will consist of Passive Accessory Intervertebral Movements (PAIVMs). The nature of PAIVMs techniques was selected by the physical therapist based on the participant's condition. Active Cervical Range of Motion Exercises (ACROM) were performed 10 repetitions 3-4 times daily. Subjects were advised to maintain their usual activity within the limits of pain. The ACROM exercise consisted of the subject placing fingers over the manubrium bone and placing chin on the fingers. The subject was then instructed to rotate to one side as far as possible and return to neutral . |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cervical Range of Motion
기간: Participants ROM measurement at baselines
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The cervical range of motion device (CROM) will be used to assess the changes in active range of motion for cervical rotation, flexion and extension when comparing baseline,week two, four and eight.
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Participants ROM measurement at baselines
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Cervical Range of Motion
기간: Participants ROM measurement at week 2
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The cervical range of motion device (CROM) will be used to assess the changes in active range of motion for cervical rotation, flexion and extension when comparing baseline, week two, four and eight.
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Participants ROM measurement at week 2
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Cervical Range of Motion
기간: Participants measurement at week four
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The cervical range of motion device (CROM) will be used to assess the changes in active range of motion for cervical rotation, flexion and extension when comparing baseline, week two, four and eight.
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Participants measurement at week four
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Cervical Range of Motion
기간: Participants ROM measurement at week 8
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The cervical range of motion device (CROM) will be used to assess the changes in active range of motion for cervical rotation, flexion and extension when comparing baseline,week two, four and eight.
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Participants ROM measurement at week 8
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Numeric Pain Rating Scale
기간: NPRS score at baseline
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Numeric pain rating scale (NPRS) is a liner outcome measurement used to determine the level of the participant's pain when comparing baseline, week two, four and eight.
It consists of a straight 10 cm line that is scored from 0 to 10 with 10 mm intervals.
The zero represents no pain while a 10 represents very severe pain that participant cannot stand.
The standard error is correct as stated.
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NPRS score at baseline
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Numeric Pain Rating Scale
기간: NPRS score at week two
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Numeric pain rating scale (NPRS) is a liner outcome measurement used to determine the level of the participant's pain when comparing baseline, week two, four and eight.
It consists of a straight 10 cm line that is scored from 0 to 10 with 10 mm intervals.
The zero represents no pain while a 10 represents very severe pain that participant cannot stand.
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NPRS score at week two
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Numeric Pain Rating Scale
기간: NPRS score at week four
|
Numeric pain rating scale (NPRS) is a liner outcome measurement used to determine the level of the participant's pain when comparing baseline, week two, four and eight.
It consists of a straight 10 cm line that is scored from 0 to 10 with 10 mm intervals.
The zero represents no pain while a 10 represents very severe pain that participant cannot stand.
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NPRS score at week four
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Numeric Pain Rating Scale
기간: NPRS score at week eight
|
Numeric pain rating scale (NPRS) is a liner outcome measurement used to determine the level of the participant's pain when comparing baseline, week two, four and eight.
It consists of a straight 10 cm line that is scored from 0 to 10 with 10 mm intervals.
The zero represents no pain while a 10 represents very severe pain that participant cannot stand.
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NPRS score at week eight
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Neck Disability Index
기간: NDI score at baseline
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Neck disability index measuring the level of neck disability when comparing baseline, week two, four, and eight.
It consists of ten items each item is scored from 0 to 5 with a minimum score 0 and highest score 50.
A score of zero (0) represents no disability while a score of 50 represents severe, full disability.
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NDI score at baseline
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Neck Disability Index
기간: NDI score at week two
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Neck disability index measuring the level of neck disability when comparing baseline, week two, four, and eight.
It consists of ten items each item is scored from 0 to 5 with a minimum score 0 and highest score 50.
A score of zero (0) represents no disability while a score of 50 represents severe, full disability.
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NDI score at week two
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Neck Disability Index
기간: NDI score at week four
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Neck disability index measuring the level of neck disability when comparing baseline, week two, four, and eight.
It consists of ten items each item is scored from 0 to 5 with a minimum score 0 and highest score 50.
A score of zero (0) represents no disability while a score of 50 represents severe, full disability.
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NDI score at week four
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Neck Disability Index
기간: NDI score at week eight
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Neck disability index measuring the level of neck disability when comparing baseline, week two, four, and eight.
It consists of ten items each item is scored from 0 to 5 with a minimum score 0 and highest score 50.
A score of zero (0) represents no disability while a score of 50 represents severe, full disability.
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NDI score at week eight
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Global Rating of Change
기간: GROC score at week two
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The Global rating of change (GROC) is used to measure the amount of improvement that the patient achieves from the intervention or rehabilitation program when comparing baseline, week two, four, and eight.
The score ranges from -7 to 0 to 7 in which -/+3 to -/+ 1 represents a small change, -/+ 4 to -/+5 represents moderate change and -/+6 to -/+7 means a large change.
The negative and positive means the patient condition worsens or improves respectively.
The points are scores on a scale (-7-0-+7 = 15 point scale).
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GROC score at week two
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Global Rating of Change
기간: GROC score at week four
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The Global rating of change (GROC) is used to measure the amount of improvement that the patient achieves from the intervention or rehabilitation program when comparing baseline, week two, four and eight.
The score ranges from -7 to 0 to 7 in which -/+3 to -/+ 1 represents a small change, -/+ 4 to -/+5 represents moderate change and -/+6 to -/+7 means a large change.
The negative and positive means the patient condition worsens or improves respectively.
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GROC score at week four
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Global Rating of Change
기간: GROC score at week eight
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The Global rating of change (GROC) is used to measure the amount of improvement that the patient achieves from the intervention or rehabilitation program when comparing baseline, week two, four and right.
The score ranges from -7 to 0 to 7 in which -/+3 to -/+ 1 represents a small change, -/+ 4 to -/+5 represents moderate change and -/+6 to -/+7 means a large change.
The negative and positive means the patient condition worsens or improves respectively.
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GROC score at week eight
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Pressure Pain Threshold
기간: Pressure Pain Threshold score at baseline
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Pressure pain threshold is an electronic device used to measure the amount of force that is required to produce pain when comparing baseline, week two, four, and eight.
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Pressure Pain Threshold score at baseline
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Pressure Pain Threshold
기간: Pressure Pain Threshold score at week two
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Pressure pain threshold is an electronic device used to measure the amount of force that is required to produce pain when comparing baseline, week two, four and eight.
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Pressure Pain Threshold score at week two
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Pressure Pain Threshold
기간: Pressure Pain Threshold score at week four
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Pressure pain threshold is an electronic device used to measure the amount of force that is required to produce pain when comparing baseline, week two, four and eight.
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Pressure Pain Threshold score at week four
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Pressure Pain Threshold
기간: Pressure Pain Threshold score at week eight
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Pressure pain threshold is an electronic device used to measure the amount of force that is required to produce pain when comparing baseline, week two, four and eight.
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Pressure Pain Threshold score at week eight
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공동 작업자 및 조사자
수사관
- 수석 연구원: Everett B Lohman, Loma Linda U
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. .
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