- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07672028
ERGON Therapy and Muscle Energy Technique for Mechanical Neck Pain (ERGOMET)
Comparison of ERGON Therapy With and Without Muscle Energy Technique in Patients With Mechanical Neck Pain: A Randomized Clinical Trial
연구 개요
상태
정황
상세 설명
Mechanical neck pain is a common musculoskeletal condition that can adversely affect daily activities, work productivity, and quality of life. Various manual therapy approaches have been used to manage neck pain, including Instrument-Assisted Soft Tissue Mobilization (IASTM) techniques such as ERGON Therapy and Muscle Energy Technique (MET). However, limited evidence exists regarding the comparative effectiveness of ERGON Therapy with and without MET in individuals with mechanical neck pain.
This randomized clinical trial will recruit 42 participants diagnosed with mechanical neck pain. Eligible participants will be randomly allocated into two groups. Group A will receive ERGON Therapy in combination with Muscle Energy Technique, while Group B will receive ERGON Therapy alone. In addition, both groups will receive a standardized conventional physiotherapy program consisting of TENS, hot pack application, and cervical stretching exercises.
The intervention period will be conducted according to a predefined treatment protocol. Outcome measures will include pain intensity assessed using the Numeric Pain Rating Scale (NPRS), cervical range of motion measured using appropriate clinical tools, and functional disability assessed using the Neck Disability Index (NDI). Assessments will be performed at baseline and after completion of the intervention period.
The primary objective of the study will be to determine whether the addition of Muscle Energy Technique to ERGON Therapy provides superior improvements in pain reduction, cervical mobility, and functional disability compared with ERGON Therapy alone. The results of this trial are expected to contribute to evidence-based rehabilitation strategies for the management of mechanical neck pain.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Sialkot, 파키스탄, 54910
- Bethania Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
Individuals clinically diagnosed with mechanical neck pain Duration of neck pain of at least 2 weeks Willingness to participate and provide written informed consent
Exclusion Criteria:
History of cervical spine surgery within the past 12 months History of trauma or infection in the cervical region Presence of neurological deficits or cervical radiculopathy Presence of systemic disorders affecting musculoskeletal function Any other musculoskeletal deformity or significant disability affecting the neck region
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공부 계획
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: Experimental Group
ERGON Therapy combined with Muscle Energy Technique plus conventional physiotherapy including TENS, hot pack application, and cervical stretching exercises.
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Participants in the experimental group will receive Instrument-Assisted Soft Tissue Mobilization using ERGON technique combined with Muscle Energy Technique.
ERGON therapy will be applied to cervical soft tissues to improve tissue mobility and reduce pain.
Muscle Energy Technique will be used to facilitate joint mobility and reduce muscular tightness.
In addition, participants will receive conventional physiotherapy including Transcutaneous Electrical Nerve Stimulation (TENS), hot pack application, and cervical stretching exercises.
다른 이름들:
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활성 비교기: Comparator Group
ERGON Therapy alone plus conventional physiotherapy including TENS, hot pack application, and cervical stretching exercises.
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Participants in the comparator group will receive Instrument-Assisted Soft Tissue Mobilization using ERGON technique alone.
ERGON therapy will be applied to cervical soft tissues to improve tissue mobility and reduce pain.
In addition, participants will receive the same conventional physiotherapy protocol including Transcutaneous Electrical Nerve Stimulation (TENS), hot pack application, and cervical stretching exercises.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Pain Intensity (NPRS)
기간: Baseline and after completion of 6 treatment sessions (2 weeks)
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Pain intensity will be assessed using the Numeric Pain Rating Scale (0-10), where 0 indicates no pain and 10 indicates worst possible pain.
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Baseline and after completion of 6 treatment sessions (2 weeks)
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Cervical Range of Motion (CROM)
기간: Baseline and after completion of 6 treatment sessions over 2 weeks
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Cervical range of motion refers to the measurement of movement of the cervical spine in different planes, including flexion, extension, lateral flexion, and rotation.
It reflects neck mobility and functional joint movement and will be assessed using standard clinical methods at baseline and post-intervention.
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Baseline and after completion of 6 treatment sessions over 2 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Functional Disability (Neck Disability Index - NDI)
기간: Baseline and after completion of 6 treatment sessions over 2 weeks
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Functional disability related to mechanical neck pain will be assessed using the Neck Disability Index (NDI).
The questionnaire measures the impact of neck pain on activities of daily living, including personal care, lifting, reading, work, and concentration.
Higher scores indicate greater disability.
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Baseline and after completion of 6 treatment sessions over 2 weeks
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공동 작업자 및 조사자
수사관
- 연구 의자: DANYAL AHMAD, University of Management and Technology Sialkot Pakistan
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
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 연구와 관련된 용어
기타 연구 ID 번호
- kuhs/dpt/umt-skt-028
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
De-identified individual participant data including baseline characteristics (age, gender), pain scores (Numeric Pain Rating Scale), cervical range of motion measurements, and Neck Disability Index scores will be shared. No personally identifiable information such as names, contact numbers, or hospital identification numbers will be included.
Supporting study documents such as study protocol and data collection forms may also be made available.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .