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Not yet recruitingNCT05882799Updated May 31, 2023

Ultrasound-guided vs. Blinded Dry Needling for Piriformis Syndrome

An interventional study of Ultrasound-guided dry needling and Blinded dry needling in Piriformis Syndrome, sponsored by Uskudar State Hospital. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-05-31.

Sponsored by Uskudar State Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Piriformis Syndrome
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In context

Piriformis Muscle Syndrome

53 studies on the registry are indexed under Piriformis Muscle Syndrome; 22 are open to participants now.

This study's planned enrollment of 60 is above the median of 42 across 47 interventional studies indexed under Piriformis Muscle Syndrome.

Browse Piriformis Muscle Syndrome studies →

Lead sponsor

Uskudar State Hospital is the lead sponsor of 27 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • 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

  • Active comparator
    Blinded dry needling group

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

    Procedure: Blinded dry needling

Interventions

  • ProcedureUltrasound-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.

  • ProcedureBlinded 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: First day, after three weeks, after three months

  2. 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.

    Time frame: First day, after three weeks, after three months

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Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — Individual participant data will be shared upon reasonable request by the corresponding author.

Supporting information: Study protocol, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05882799
Lead sponsor
Uskudar State Hospital
Responsible party
Mustafa Hüseyin Temel (Principal Investigator, Uskudar State Hospital) — Principal investigator
First posted
May 31, 2023
Start date
Jul 1, 2023 (estimated)
Primary completion
Dec 1, 2023 (estimated)
Completion
Feb 1, 2024 (estimated)
Last update
May 31, 2023

Study contacts

Mustafa H Temel, M.D.
Contact
mhuseyintemel@gmail.com
+905342714872
Fatih Bağcıer, M.D.
Contact
bagcier_42@hotmail.com
05442429042
Mustafa H Temel, M.D.
principal investigator · Uskudar State Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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