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正在招募不适用编号 NCT07058636

Efficacy of Adding Greater Occipital Nerve Block to Trigger Point Injection in Patients With Neck Pain

报名条件(概要)

  • 年龄:18 Years65 Years
  • 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

Turkey (Türkiye)

研究药物 / 干预措施

2% Lidocaine HCl + saline、Steroid+lidocaine

申办方

Ankara Etlik City Hospital

研究简介(原文)

Study Title: Evaluation of the Effectiveness of Adding Greater Occipital Nerve Block to Trigger Point Injection in Patients with Neck Pain Due to Upper Trapezius Trigger Points: A Single-Blind Randomized Controlled Trial Purpose of the Study: This study aims to evaluate whether adding a Greater Occipital Nerve (GON) block to the standard trigger point injection treatment provides better pain relief and improves daily function in patients with neck pain caused by trigger points in the upper trapezius muscle. Trigger points are small, sensitive spots in muscles that can cause significant pain and discomfort. While both trigger point injections and GON blocks are common treatments for neck and head pain, it is not yet clear if combining these two methods offers better results. Why is this study important? Neck pain related to trigger points in the upper trapezius muscle is a frequent problem, but there is limited research on the effectiveness of combining trigger point injections with GON blocks. This study will provide important information on whether the combination therapy can reduce pain more effectively and improve patients' quality of life and ability to perform daily activities. Who can participate? Adults aged 18 to 65 years old Diagnosed with myofascial pain syndrome (MAS) based on specific clinical criteria, including the presence of trigger points in the upper trapezius muscle Experiencing neck pain lasting longer than 3 months Pain intensity rated 5 or higher on a scale of 0 to 10 Who cannot participate? Pregnant or breastfeeding women, children, elderly people, unconscious or critically ill patients Patients with allergies to local anesthetics or steroids Individuals with bleeding disorders or infections near the injection site Patients with serious psychiatric or neurological diseases, or other medical conditions that may affect study results Those who have recently received similar treatments or surgery for neck or shoulder problems Study Design and Procedures: The study will include 60 patients meeting the criteria, randomly assigned to two groups using a balanced randomization method. Group A will receive only trigger point injections into the upper trapezius muscle using a mixture of lidocaine and saline solution. Group B will receive both trigger point injections and an ultrasound-guided GON block, which involves injecting a combination of local anesthetics and steroid near the greater occipital nerve to reduce pain signals. Both groups will receive the same home exercise program focusing on stretching and strengthening neck muscles to support recovery. Patients will be encouraged to perform these exercises regularly and will be followed up weekly by phone to check their progress. The doctor assessing patients' progress will not know which treatment the patient received, to ensure unbiased results. Assessments: Patients will be evaluated at three different times: before treatment, 1 week after treatment, and 4 weeks after treatment. Assessments include: Pain intensity and quality (using Visual Analog Scale and McGill Pain Questionnaire) Neck disability and ability to perform daily activities (Neck Disability Index) Quality of life (Nottingham Health Profile) Neck joint movement and position sense (using clinical tests with special equipment) Posture evaluation (measuring head position using photography) Expected Outcomes: The main goal is to determine if the combined treatment of trigger point injection plus GON block is more effective than trigger point injection alone in reducing pain, improving neck function, and enhancing quality of life. Duration and Follow-Up: The study is planned to last 12 months. Patients will be closely monitored during and after treatment to ensure safety and to collect necessary data. Potential Benefits and Risks: Participants may experience pain relief and improved function if the combined treatment is effective. Risks include mild discomfort or side effects related to injections, which will be minimized by experienced medical staff.

适应症

Neck PainMyofacial Pain SyndromeTrigger Point Pain, MyofascialTrigger PointsUpper Trapezius Trigger PointsCervicogenic Headache

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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。

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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: Efficacy of Adding Greater Occipital Nerve Block to Trigger Point Injection in Patients With Neck Pain
ClinicalTrials.gov Identifier: NCT07058636
Sponsor: Ankara Etlik City Hospital
Investigational product: 2% Lidocaine HCl + saline, Steroid+lidocaine

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:Efficacy of Adding Greater Occipital Nerve Block to Trigger Point Injection in Patients With Neck Pain
试验编号:NCT07058636
申办方:Ankara Etlik City Hospital
研究药物:2% Lidocaine HCl + saline、Steroid+lidocaine

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 ilaydagerdan@gmail.com

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