Ultrasound-guided vs. Blinded Dry Needling for Piriformis Syndrome

NCT ID: NCT05882799

Last Updated: 2023-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-02-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Piriformis Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The outcomes assessor will be blinded.

Study Groups

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Ultrasound-guided dry needling group

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

Group Type ACTIVE_COMPARATOR

Ultrasound-guided dry needling

Intervention Type 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.

Blinded dry needling group

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

Group Type ACTIVE_COMPARATOR

Blinded dry needling

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uskudar State Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Mustafa Hüseyin Temel

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mustafa H Temel, M.D.

Role: PRINCIPAL_INVESTIGATOR

Uskudar State Hospital

Central Contacts

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Mustafa H Temel, M.D.

Role: CONTACT

Phone: +905342714872

Email: [email protected]

Fatih Bağcıer, M.D.

Role: CONTACT

Phone: 05442429042

Email: [email protected]

Other Identifiers

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Priformis1

Identifier Type: -

Identifier Source: org_study_id