Ultrasound-guided vs. Blinded Dry Needling for Piriformis Syndrome: A Randomized Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 主要终点
- Change in Visual Analog Scale for Pain
研究概览
简要总结
This randomized controlled trial aims to compare the effectiveness of ultrasound-guided versus blinded dry needling for the treatment of piriformis syndrome.
详细描述
This randomized controlled trial aims to compare the efficacy of ultrasound-guided versus blinded dry needling for the treatment of piriformis syndrome. Patients in both groups will receive three weekly sessions of dry needling performed by a single experienced physiatrist. The intervention will involve inserting a sterile acupuncture needle into the trigger points of the piriformis muscle and manipulating the needle to elicit a twitch response. Patients in the ultrasound-guided group will receive dry needling under real-time ultrasound guidance, while patients in the blinded group will receive dry needling without ultrasound guidance. Patients will be assessed before treatment, after treatment, after the third week, and after three months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor will be blinded.
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
- •Male or female patients aged 18-65 years.
- •Clinical diagnosis of piriformis syndrome based on the following criteria: buttock pain, radiating pain to the posterior thigh, and tenderness over the piriformis muscle.
- •Pain intensity of at least 4 out of 10 on a visual analog scale (VAS).
- •Willingness to comply with the study protocol and provide informed consent.
排除标准
- •Previous surgery or injection therapy for piriformis syndrome.
- •Contraindications to dry needling, such as bleeding disorders or skin infections.
- •Pregnancy or breastfeeding.
- •History of neurological disorders, such as sciatica, radiculopathy, or neuropathy.
- •History of serious psychiatric illness or substance abuse.
- •Inability to complete the study questionnaires or follow-up assessments.
结局指标
主要结局
Change in Visual Analog Scale for Pain
时间窗: First day, after three weeks, after three months
A Visual Analog Scale (VAS) for pain is a commonly used tool to measure the intensity of pain experienced by a patient. It typically consists of a horizontal or vertical line, typically 10 centimeters long, with endpoints labeled as "no pain" and "worst possible pain." The patient is asked to mark on the line the point that best represents the intensity of their pain, with the distance from the "no pain" end of the line to the patient's mark representing the pain score.
Change in Oswestry Disability Index (ODI)
时间窗: First day, after three weeks, after three months
The Oswestry Disability Index (ODI) is a self-administered questionnaire that is widely used to assess the functional status of patients with low back pain or sciatica. The ODI consists of 10 sections, each relating to a different aspect of functional impairment, such as pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and employment/homemaking. Each section is scored on a scale of 0-5, with a total score ranging from 0 (no disability) to 50 (complete disability). The ODI is a validated and reliable tool for assessing functional status and has been used in many clinical trials to evaluate the effectiveness of interventions for low back pain or sciatica.
次要结局
未报告次要终点
研究者
Mustafa Hüseyin Temel
Principal Investigator
Uskudar State Hospital