- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07594223
Efficacy of Activator Trigger Point and Shock Wave Therapy on Pain and Function in Active Upper Trapezius Trigger Points: A Randomized Controlled Study
This study will be conducted as a randomized controlled trial to evaluate the efficacy of trigger point activator and extracorporeal shock wave therapy in patients with active myofascial trigger points in the upper fibers of the trapezius muscle. Participants who meet the inclusion criteria will be recruited and informed consent will be obtained prior to participation. The subjects will then be randomly allocated into two equal groups. Group A: will receive treatment using the trigger point activator applied to the active trigger points of the upper trapezius muscle. Group B: will receive extracorporeal shock wave therapy applied to the same region.
The treatment will be applied according to standardized therapeutic parameters for a predetermined number of sessions over the study period. Outcome measures will be assessed before the beginning of the treatment program and after completion of the intervention period. Pain intensity and pressure pain threshold will be assessed using an algometer. Functional disability related to the neck will be evaluated using the Neck Disability Index (NDI). All collected data will be recorded and statistically analyzed to determine the effectiveness of both treatment modalities in reducing pain and improving functional outcomes.
연구 개요
상세 설명
This study will be conducted as a randomized controlled trial to evaluate the efficacy of trigger point activator and extracorporeal shock wave therapy in patients with active myofascial trigger points in the upper fibers of the trapezius muscle. Participants who meet the inclusion criteria will be recruited and informed consent will be obtained prior to participation. The subjects will then be randomly allocated into two equal groups. Group A: will receive treatment using the trigger point activator applied to the active trigger points of the upper trapezius muscle. Group B: will receive extracorporeal shock wave therapy applied to the same region.
The treatment will be applied according to standardized therapeutic parameters for a predetermined number of sessions over the study period. Outcome measures will be assessed before the beginning of the treatment program and after completion of the intervention period. Pain intensity and pressure pain threshold will be assessed using an algometer. Functional disability related to the neck will be evaluated using the Neck Disability Index (NDI). All collected data will be recorded and statistically analyzed to determine the effectiveness of both treatment modalities in reducing pain and improving functional outcomes. 15. Participants of the study:
- The number of participants: 200 (50 per group to ensure 40 completers per arm after attrition).
Important characteristics
- Adult (27:40 years):
- Gender: both gender
Diagnosis: Active upper trapezius trigger points Inclusion criteria
- Male or female participants aged between 25 and 40 years.
- Body Mass Index (BMI) between 20 and 30 kg/m².
- Presence of active myofascial trigger points in the upper fibers of the trapezius muscle confirmed by clinical examination.
- Complaints of neck pain associated with upper trapezius trigger points.
- Ability and willingness to participate in the treatment sessions and follow the study protocol.
Exclusion criteria:
- History of neck trauma, cervical spine fracture, or cervical spine surgery.
- Presence of neurological disorders affecting the cervical region.
- Presence of cervical disc prolapse or severe cervical spine pathology.
- Diagnosis of fibromyalgia or systemic musculoskeletal disorders.
- Presence of skin diseases, wounds, or infections at the treatment area.
- Patients with malignancy or severe systemic diseases.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Mina Wahba, phD
- 전화번호: +062 3707068
- 이메일: mina.magdy@the.suezuni.edu.eg
연구 장소
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Suez, 이집트
- Suez Uni
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연락하다:
- Doha Hamed, PhD
- 이메일: dohahamed@buc.edu.eg
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
1. Male or female participants aged between 25 and 40 years. 2. Body Mass Index (BMI) between 20 and 30 kg/m². 3.Presence of active myofascial trigger points in the upper fibers of the trapezius muscle confirmed by clinical examination.
- Complaints of neck pain associated with upper trapezius trigger points. 5. Ability and willingness to participate in the treatment sessions and follow the study protocol.
Exclusion Criteria:
- 1. History of neck trauma, cervical spine fracture, or cervical spine surgery. 2. Presence of neurological disorders affecting the cervical region. 3. Presence of cervical disc prolapse or severe cervical spine pathology. 4. Diagnosis of fibromyalgia or systemic musculoskeletal disorders. 5. Presence of skin diseases, wounds, or infections at the treatment area. 6. Patients with malignancy or severe systemic diseases.
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: treatment
receive treatment using the trigger point activator applied to the active trigger points of the upper trapezius muscle.
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will receive treatment using the trigger point activator applied to the active trigger points of the upper trapezius muscle.
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활성 비교기: Shockwave
will receive extracorporeal shock wave therapy applied to the same region.
The treatment will be applied according to standardized therapeutic parameters for a predetermined number of sessions over the study period.
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will receive extracorporeal shock wave therapy applied to the same region.
12.
The treatment will be applied according to standardized therapeutic parameters for a predetermined number of sessions over the study period.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Neck Disability Index (NDI)
기간: 6 weeks
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Questionnaire assessing neck function valid and reilable
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6 weeks
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VAS
기간: 6 weeks
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Pain score
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6 weeks
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공동 작업자 및 조사자
스폰서
협력자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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 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. .