Ultrasound-guided vs. Blinded Dry Needling for Piriformis Syndrome

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Piriformis Syndrome
• Intervention / Treatment: Procedure: Ultrasound-guided dry needling; Procedure: Blinded dry needling

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mustafa H Temel, M.D.; Phone Number: +905342714872; Email: mhuseyintemel@gmail.com
• Study Contact Backup: Name: Fatih Bağcıer, M.D.; Phone Number: 05442429042; Email: bagcier_42@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ultrasound-guided dry needling group; Patients in this group will receive dry needling for piriformis syndrome under real-time ultrasound guidance.	Procedure: Ultrasound-guided dry needling; 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.
Active Comparator: Blinded dry needling group; Patients in this group will receive dry needling for piriformis syndrome without ultrasound guidance.	Procedure: Blinded dry needling; 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.

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

Collaborators and Investigators

• Sponsor: Uskudar State Hospital
• Investigators: Principal Investigator: Mustafa H Temel, M.D., Uskudar State Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: May 7, 2023
• First Submitted That Met QC Criteria: May 20, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 20, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Pain; Neurologic Manifestations; Disease; Neuromuscular Diseases; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuralgia; Nerve Compression Syndromes; Pelvic Pain; Syndrome; Piriformis Muscle Syndrome
• Other Study ID Numbers: Priformis1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data will be shared upon reasonable request by the corresponding author.
• IPD Sharing Time Frame: 1 month.
• IPD Sharing Access Criteria: Individual participant data will be shared upon reasonable request by the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No