Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05882799
Other study ID # Priformis1
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2023
Est. completion date February 1, 2024

Study information

Verified date May 2023
Source Uskudar State Hospital
Contact Mustafa H Temel, M.D.
Phone +905342714872
Email mhuseyintemel@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date February 1, 2024
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Uskudar State Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT04387877 - Graston Technique in Deep Gluteal Syndrome N/A
Recruiting NCT06130618 - The Effects of Ultrasound Guided Ozone and Lidocaine Injections in Piriformis Syndrome N/A
Completed NCT05680402 - Effects of Soft Tissue Mobilization Technique and Piriformis Muscle Stretching Among Patients Having Piriformis Syndrome N/A
Active, not recruiting NCT06437795 - Effectiveness of Dry Needling Versus Cupping Therapy for Pain in Piriformis Syndrome N/A
Completed NCT04603703 - Sacroiliac Joint Manipulation Effect in Chronic Piriformis Syndrome. N/A
Completed NCT01752179 - Kinesio Taping Technique and Trigger Point N/A
Completed NCT06435169 - Comparative Presence of Piriformis Syndrome in Patients With Lumbar Disc Bulging and Protrusion
Completed NCT05848063 - Effects of Global Hip Versus Isolated Abductors Strengthening Exercises in Patients Withsecondary Piriformis Syndrome N/A
Completed NCT05271071 - The Importance of Gluteus Maximus Muscle in Patients With Preliminary Diagnosis of Piriformis Syndrome N/A
Completed NCT04842656 - Soft Tissue Techniques in Piriformis Syndrome N/A
Not yet recruiting NCT05404607 - Effects of Fascial Distortion Model With and Without Neuromuscular Inhibition in Patients With Piriformis Syndrome N/A
Recruiting NCT06437327 - Comparison of Effectiveness Between Active Release Technique and Hold Relax Technique in Patients With Piriformis Syndrome N/A
Recruiting NCT06102733 - Chronic Pelvic Pain in Females and Males
Not yet recruiting NCT05392933 - Investigation of the Presence of Piriformis Syndrome Accompanying Lumbar Radiculopathy N/A
Completed NCT04588779 - Graston vs Manual Myofascial Release Technique in Piriformis Syndrome. N/A
Recruiting NCT06406023 - Effectiveness of Instrument Assisted Soft Tissue Mobilization in Management of Piriformis Syndrome N/A
Completed NCT04684537 - Effect of Ultrasound-guided Piriformis Muscle Corticosteroid Injection Versus Extracorporeal Shock Wave Therapy for Piriformis Syndrome: a Randomized Control Trial N/A
Completed NCT05742633 - Comparative Effect of Active Release Technique Versus Self-myofascial Release in Improving Piriformis Syndrome N/A
Completed NCT05370378 - Effects of Hold Relax With Agonist Contraction and Active Release Therapy on Clinical Outcomes in Piriformis Syndrome N/A
Recruiting NCT05915858 - Muscle Energy Technique and Stretching Exercise in Working Pregnant Women With Piriformis Syndrome N/A