Can We Reliably Needle Hip Region Muscles Without Imaging? A Muscle-Specific Accuracy Study Using Ultrasound
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Accuracy of Blinded Dry Needling Injections
研究概览
简要总结
The aim of this study is to evaluate the accuracy of invasive interventions (dry needling or injection) performed on specific muscles of the hip region in reaching the anatomical target. The accuracy of the interventions performed with a blinded method will be compared with an observational assessment supported by ultrasonography. The interventions will be performed by a physician with clinical experience, and the anatomical location of the needle tip will be evaluated by a second physician with ultrasonography after each procedure. The targeted muscles include the iliacus, pectineus, sartorius, tensor fascia latae, and rectus femoris. Each participant will be subjected to interventions for five different muscles, and a total of at least 40 injection interventions will be analyzed. Ultrasonography will be used only for observation and verification purposes; no pharmacological substances will be applied during the procedure. All procedures will be performed under sterile conditions, and participants will be monitored for 24 hours for possible pain, bruising, or complications. Participants will be informed about the content and purpose of the study, and written informed consent forms will be obtained. The study does not have a therapeutic purpose and is only intended to investigate targeting accuracy. The data to be obtained is expected to contribute to the determination of anatomical accuracy rates in clinical practices and the improvement of interventional training processes.
详细描述
This study aims to evaluate the accuracy of muscle targeting when dry needling injections are performed using the blinded (anatomical landmark-based) technique. The accuracy of these injections will be assessed by confirming the needle placement with ultrasonography immediately after each attempt.
According to existing literature, the accuracy of blinded injection techniques is reported to be approximately 67%, while ultrasound-guided injections achieve an accuracy of about 92%. A power analysis was conducted using these proportions to detect a statistically significant difference between the two methods. Based on these values, Cohen's h effect size was calculated as 0.66. With a significance level (alpha) of 0.05 and a statistical power of 80%, a minimum of 74 injection attempts are required.
In this study, each participant will receive injections into five different muscles suspected to be involved in myofascial pain. With 15 participants, this will result in 75 injection attempts, thereby meeting the required sample size for adequate power.
Eligible participants will be adults aged 18-65 presenting with nonspecific hip, groin, or anterior thigh pain and referred for physical therapy. The study particularly focuses on individuals with suspected myofascial pain syndrome in deep or less accessible hip-related muscles, such as the iliacus, pectineus, and sartorius. All participants must be clinically indicated for dry needling or similar interventions and capable of cooperating with the procedure.
Ultrasonographic evaluation will be used only to confirm needle placement, not to guide the injection. This allows for the assessment of the real-world accuracy of the blinded technique, which is commonly used in routine clinical practice. The findings will provide insight into the reliability of this method and help guide training and clinical decision-making in musculoskeletal and pain management practices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 65 years
- •Individuals with nonspecific hip, groin, or anterior thigh pain who are scheduled for physical therapy
- •Clinical suspicion of myofascial pain syndrome, particularly involving muscles around the hip
- •Patients with clinical indication for dry needling or similar invasive treatments (e.g., targeting muscles such as iliacus, pectineus, sartorius)
- •Ability to cooperate with the procedure
- •Ability to provide written informed consent
排除标准
- •Use of anticoagulant medications (due to increased risk of bleeding)
- •Severe hip osteoarthritis, presence of hip prosthesis, history of previous hip surgery, or significant anatomical deformity
- •Active infection or skin lesion at the planned injection site
- •Inability to cooperate or communicate effectively
- •Pregnancy
- •Presence of serious systemic illnesses (e.g., malignancy, neurological disorders)
研究组 & 干预措施
Blind Dry Needling Lumbar Paraspinal Muscles
Dry needling is performed using anatomical landmarks without ultrasound guidance. Needle placement is then confirmed via ultrasound imaging.
干预措施: Blinded Dry Needling (Procedure)
结局指标
主要结局
Accuracy of Blinded Dry Needling Injections
时间窗: Immediately after each injection attempt
Proportion of injection attempts in which the needle accurately reaches the intended target muscle using the blinded (anatomical landmark-based) technique, as confirmed by ultrasonography.
次要结局
- Accuracy Rate per Target Muscle(Immediately after each injection attempt)
研究者
nurmuhammet tas
dr.
Erzurum Regional Training & Research Hospital