Ultrasound-guided vs. Blinded Dry Needling for Piriformis Syndrome

Study Overview
=================
Brief Summary
-----------------
This randomized controlled trial aims to compare the effectiveness of ultrasound-guided versus blinded dry needling for the treatment of piriformis syndrome.

Detailed Description
-----------------
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.

Official Title
-----------------
Ultrasound-guided vs. Blinded Dry Needling for Piriformis Syndrome: A Randomized Trial

Conditions
-----------------
Piriformis Syndrome

Intervention / Treatment
-----------------
* Procedure: Ultrasound-guided dry needling
* Procedure: Blinded dry needling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultrasound-guided dry needling group<br>Patients in this group will receive dry needling for piriformis syndrome under real-time ultrasound guidance. | Procedure: Ultrasound-guided dry needling<br>* Ultrasound-guided dry needling is a minimally invasive technique that involves inserting a sterile acupuncture needle into trigger points of a muscle while monitoring the needle's progress with real-time ultrasound imaging. In this technique, a trained practitioner visualizes the piriformis muscle and the surrounding structures using an ultrasound machine, and then inserts the needle through the skin and into the muscle tissue, guided by the ultrasound image.<br>|
| Active Comparator: Blinded dry needling group<br>Patients in this group will receive dry needling for piriformis syndrome without ultrasound guidance. | Procedure: Blinded dry needling<br>* Blinded dry needling is a minimally invasive technique that involves inserting a sterile acupuncture needle into trigger points of a muscle without using real-time imaging guidance. In this technique, the practitioner relies solely on their palpation skills to locate the trigger points of the piriformis muscle and inserts the needle through the skin and into the muscle tissue.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Analog Scale for Pain | 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. | First day, after three weeks, after three months | 
| Change in Oswestry Disability Index (ODI) | 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. | First day, after three weeks, after three months |