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Efficacy of Activator Trigger Point and Shock Wave Therapy on Pain and Function in Active Upper Trapezius Trigger Points: A Randomized Controlled Study

2026年5月14日 更新者:Mina Magdy Wahba、Cairo University

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.

研究概览

地位

尚未招聘

条件

详细说明

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:

  1. The number of participants: 200 (50 per group to ensure 40 completers per arm after attrition).
  2. Important characteristics

    • Adult (27:40 years):
    • Gender: both gender
    • Diagnosis: Active upper trapezius trigger points 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.
      4. 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.

研究类型

介入性

注册 (估计的)

100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:treatment
receive treatment using the trigger point activator applied to the active trigger points of the upper trapezius muscle.
will receive treatment using the trigger point activator applied to the active trigger points of the upper trapezius muscle.
有源比较器: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.
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Neck Disability Index (NDI)
大体时间:6 weeks
Questionnaire assessing neck function valid and reilable
6 weeks
VAS
大体时间:6 weeks
Pain score
6 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月1日

初级完成 (估计的)

2026年11月12日

研究完成 (估计的)

2026年12月1日

研究注册日期

首次提交

2026年5月7日

首先提交符合 QC 标准的

2026年5月14日

首次发布 (实际的)

2026年5月18日

研究记录更新

最后更新发布 (实际的)

2026年5月18日

上次提交的符合 QC 标准的更新

2026年5月14日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • SuezU1

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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