Back to resultsUltrasound-guided vs. Blinded Dry Needling for Piriformis Syndrome
Primary Purpose
Piriformis Syndrome
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasound-guided dry needling
Blinded dry needling
Sponsored by
About this trial
This is an interventional treatment trial for Piriformis Syndrome
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ultrasound-guided dry needling group
Blinded dry needling group
Arm Description
Patients in this group will receive dry needling for piriformis syndrome under real-time ultrasound guidance.
Patients in this group will receive dry needling for piriformis syndrome without ultrasound guidance.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05882799
Brief Title
Ultrasound-guided vs. Blinded Dry Needling for Piriformis Syndrome
Official Title
Ultrasound-guided vs. Blinded Dry Needling for Piriformis Syndrome: A Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uskudar State Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Piriformis Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Trial
Masking
Outcomes Assessor
Masking Description
The outcomes assessor will be blinded.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound-guided dry needling group
Arm Type
Active Comparator
Arm Description
Patients in this group will receive dry needling for piriformis syndrome under real-time ultrasound guidance.
Arm Title
Blinded dry needling group
Arm Type
Active Comparator
Arm Description
Patients in this group will receive dry needling for piriformis syndrome without ultrasound guidance.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided dry needling
Intervention Description
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
Intervention Name(s)
Blinded dry needling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Visual Analog Scale for Pain
Description
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.
Time Frame
First day, after three weeks, after three months
Title
Change in Oswestry Disability Index (ODI)
Description
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.
Time Frame
First day, after three weeks, after three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mustafa H Temel, M.D.
Phone
+905342714872
Email
mhuseyintemel@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fatih Bağcıer, M.D.
Phone
05442429042
Email
bagcier_42@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mustafa H Temel, M.D.
Organizational Affiliation
Uskudar State Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Ultrasound-guided vs. Blinded Dry Needling for Piriformis Syndrome
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