Ultrasound-guided vs. Blinded Dry Needling for Piriformis Syndrome

NCT05882799 | Unknown

• 1 other identifier: Priformis1
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Piriformis Syndrome

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Ultrasound-guided dry needling group

ACTIVE COMPARATOR

Patients in this group will receive dry needling for piriformis syndrome under real-time ultrasound guidance.

Procedure: Ultrasound-guided dry needling

Blinded dry needling group

ACTIVE COMPARATOR

Patients in this group will receive dry needling for piriformis syndrome without ultrasound guidance.

Procedure: Blinded dry needling

Interventions

Ultrasound-guided dry needling PROCEDURE

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.

Ultrasound-guided dry needling group

Blinded dry needling PROCEDURE

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.

Blinded dry needling group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uskudar State Hospital: lead

MeSH Terms

Conditions

Piriformis Muscle Syndrome

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pelvic Pain

Study Officials

• Mustafa H Temel, M.D.

  Uskudar State Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mustafa H Temel, M.D.

CONTACT

+905342714872; mhuseyintemel@gmail.com

Fatih Bağcıer, M.D.

CONTACT

05442429042; bagcier_42@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Trial

Study Record Dates

• First Submitted: May 7, 2023
• First Posted: May 31, 2023
• Study Start: July 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: February 1, 2024
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 1 month.
• Access Criteria: Individual participant data will be shared upon reasonable request by the corresponding author.