返回搜索
正在招募不适用编号 NCT07660523

Focused Shockwave Therapy for Neck and Shoulder Myofascial Pain

报名条件(概要)

  • 年龄:20 Years – 不限
  • 性别:不限
  • 健康志愿者:不接受

完整入排标准请以官方页面为准。

开展国家/地区

Taiwan

药品与企业信息

Second-Generation Focused Extracorporeal Shockwave Therapy医疗器械

Second-generation focused extracorporeal shockwave therapy will be applied to clinically identified tight and painful regions of the upper trapezius and levator scapulae muscles. Treatment will be administered using the Richard Wolf PiezoWave system once weekly for 3 consecutive weeks. Each session will include approximately 3,000 shockwave pulses at a treatment depth of 20 to 25 mm and a frequency of 2 to 4 Hz. The treatment energy level will begin at level 4 and may be gradually increased to a maximum of level 15 according to the participant's clinical response and tolerance.

Home-Based Neck Exercise Program行为干预

Participants will perform a standardized home-based neck exercise program for 3 weeks. The program includes cervical flexion, extension, right and left rotation, right and left lateral flexion, and right and left upper cervical rotation performed with the neck in a flexed position. Each exercise will be performed for 20 repetitions per set, for 3 sets, 5 times per day. Participants will receive initial instruction and movement correction from a qualified physical therapist, together with written educational materials. Adherence and exercise-related difficulties will be monitored during the study.

研发企业

Cishan Hospital, Ministry of Health and Welfare研究机构/其他

试验官方登记的主要申办方;研究机构申办时会显示相应机构名称。

生产企业

公开药品批准资料或正式说明书暂未提供明确的生产企业信息。

研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业;生产企业仅取自美国上市原研药说明书所列企业(不含仿制药),不作推测;仅在其他国家上市的药品暂无法显示。

研究简介(原文)

Myofascial pain syndrome of the neck and shoulder is a common condition characterized by persistent muscle pain, tenderness, stiffness, and limitations in daily activities. Focused extracorporeal shockwave therapy is a noninvasive treatment that may reduce pain and improve muscle function. However, additional clinical evidence is needed regarding the effectiveness of second-generation focused shockwave therapy and whether ultrasound imaging can objectively detect changes in muscle function after treatment. This pilot randomized controlled trial will enroll 60 adults with chronic neck and shoulder myofascial pain syndrome. Participants will be randomly assigned to either a focused shockwave therapy group or a home-based neck exercise group. Participants in the focused shockwave therapy group will receive one treatment session per week for three consecutive weeks. Participants in the control group will perform a standardized home exercise program designed to improve neck mobility and reduce muscle tightness. Assessments will be performed before the intervention, after the intervention, and at follow-up. Study outcomes will include pain intensity measured using the Visual Analogue Scale, neck-related disability measured using the Neck Disability Index, pressure pain threshold measured using an algometer, and upper trapezius muscle thickness and contraction-related changes measured using ultrasound imaging. The primary objective is to determine whether focused shockwave therapy is more effective than a home-based neck exercise program in reducing pain and improving neck function. The study will also evaluate whether ultrasound-derived muscle measurements are associated with changes in pain, pressure sensitivity, and functional disability.

适应症

Myofascial Pain Syndrome

主动联系研究团队

这项试验目前在中国大陆没有研究中心

这种情况下,直接发"入组咨询"往往会被回复"您所在地区没有中心"。更有效的做法是申请同情用药/扩展准入(由主治医生一同提出),或询问能否到最近的境外中心参加。下面已为您切换到对应的信件版本。

查看完整申请路径与成功率说明 →

总联系人(申办方/研究总部)

中国/港澳台研究中心

问自己是否符合条件、如何预筛

我的病情档案

管理档案

档案只保存在您自己的浏览器里,不会上传,任何人(包括本站)都看不到。

英文版(发给研究团队)

Dear Study Team,

I am a patient in China and I am interested in participating in your clinical trial:

Study Title: Focused Shockwave Therapy for Neck and Shoulder Myofascial Pain
ClinicalTrials.gov Identifier: NCT07660523
Sponsor: Cishan Hospital, Ministry of Health and Welfare
Investigational product: Second-Generation Focused Extracorporeal Shockwave Therapy, Home-Based Neck Exercise Program

About me:
- Age: (please fill in)
- Sex: (please fill in)
- Confirmed diagnosis and stage: (please fill in)
- Biomarkers / genetic testing: not available
- Prior and current treatments: (please fill in)
- Performance status (ECOG): not assessed
- Current location: China
- Travel ability: (please fill in)

Could you please let me know:
1. Whether I might be eligible for this study;
2. Which site would be closest and most practical for me, and whether remote pre-screening is possible;
3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening.

I can provide English translations of my medical records. Thank you very much for your time and help.

Kind regards,
(your name)
(your email / phone with country code)

中文对照(供您核对)

尊敬的研究团队:

我是一位来自中国的患者,希望咨询参加以下临床试验的可能:

研究名称:Focused Shockwave Therapy for Neck and Shoulder Myofascial Pain
试验编号:NCT07660523
申办方:Cishan Hospital, Ministry of Health and Welfare
研究药物:Second-Generation Focused Extracorporeal Shockwave Therapy、Home-Based Neck Exercise Program

我的基本情况:
- 年龄:(请填写)
- 性别:(请填写)
- 确诊疾病与分期:(请填写)
- 基因/标志物检测:暂无
- 既往及当前治疗:(请填写)
- 体能状态(ECOG):未评估
- 目前所在城市:中国
- 可前往范围:(请填写)

想请教三个问题:
1. 我是否可能符合本研究的入组标准?
2. 哪个中心对我最方便可行?能否远程预筛?
3. 预筛需要准备哪些资料(病历、病理、影像、近期化验)?

我可以提供英文翻译版病历。感谢您的时间与帮助。

顺祝安康
(您的姓名)
(您的邮箱/带国际区号的电话)
用邮件客户端发送给 ivywei@chis.mohw.gov.tw

提示:请与主治医生一起发信——由医生署名的申请,回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复,两周无回音可礼貌追问一次。

下一步怎么做?

  1. 把本页信息带给您的主治医生,评估是否适合参加。
  2. 点击下方按钮打开官方注册页,查看研究中心联系方式。
  3. 直接联系研究团队咨询报名事宜(通常有中文同声翻译服务可协助沟通)。
在 ClinicalTrials.gov 查看官方页面