Ultrasound-guided vs. Blinded Dry Needling for Piriformis Syndrome

Sponsor

Uskudar State Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05882799

Collaborator

(none)

Enrollment

Arms

7.1

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Piriformis Syndrome	Procedure: Ultrasound-guided dry needling Procedure: Blinded dry needling	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized TrialRandomized Trial

Masking:

Single (Outcomes Assessor)

Masking Description:

The outcomes assessor will be blinded.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in Visual Analog Scale for Pain [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Uskudar State Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mustafa Hüseyin Temel, Principal Investigator, Uskudar State Hospital

ClinicalTrials.gov Identifier:

NCT05882799

Other Study ID Numbers:

Priformis1

First Posted:

May 31, 2023

Last Update Posted:

May 31, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Piriformis Muscle Syndrome

Syndrome

Study Results

No Results Posted as of May 31, 2023