Interfascial hydrodissection added to ultrasound-guided piriformis injection for piriformis syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates if performing ultrasound-guided interfascial hydrodissection between the gluteus maximus and piriformis muscles, in addition to a standard ultrasound-guided piriformis injection and a home stretching program, provides greater pain relief and functional improvement for piriformis syndrome. Participants must have signs and exam findings consistent with piriformis syndrome and respond to a diagnostic piriformis injection to be randomized. The trial uses a standardized protocol and follows patients over a defined follow-up period to compare outcomes between treatment arms. Safety monitoring and eligibility criteria are outlined, including exclusion of other hip or spine conditions and requirements for informed consent and follow-up adherence.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 to 70 years.
* Buttock or gluteal pain that may radiate to the posterior thigh and/or leg.
* Medical history and physical examination findings consistent with piriformis syndrome.
* Tenderness on palpation over the piriformis muscle.
* A positive result on at least one of the following piriformis provocation maneuvers: FAIR, Freiberg, Pace, or Beatty.
* Exclusion of lumbar radiculopathy, clinically significant hip pathology, and other major causes of buttock or leg pain by clinical assessment and, when clinically indicated, review of available routine imaging.
* Ability to understand and sign the written informed consent form.
* Ability and willingness to attend the scheduled follow-up visits.

Additional criterion for randomization:

\- At least a 50 percent early reduction in overall pain after the single ultrasound-guided local anesthetic piriformis injection.

Exclusion Criteria:

* Active lumbar radiculopathy, clinically significant lumbar disc herniation, spinal stenosis, or another spinal disorder that could explain the participant's symptoms.
* Clinically significant neurological deficit.
* Marked limitation of lumbar spine and/or hip range of motion.
* Previous surgery involving the lumbar spine or hip region.
* Pregnancy or breastfeeding.
* Known allergy or hypersensitivity to lidocaine or another local anesthetic used in the study.
* Current anticoagulant treatment or a clinically significant coagulation disorder.
* Active infection at the injection site.
* Body mass index greater than 35 kg/m².
* Active inflammatory or infectious disease that may affect participant safety or study assessments.
* Active psychiatric condition that may interfere with informed consent, adherence to study procedures, or outcome assessment.
* Uncontrolled hypertension.
* Uncontrolled diabetes mellitus.
* Decompensated cardiac, hepatic, or renal failure.
* Vascular or neoplastic disease that could explain the symptoms or increase the risk of the study procedures.
* Injection, dry needling, or a similar intervention in the gluteal region within the previous 3 months.
* Inability or unwillingness to complete the scheduled follow-up visits.

Where it's running

• University of Health Sciences, Haydarpasa Numune Training and Research Hospital, Department of Physical Medicine and Rehabilitation
  Istanbul, Uskudar, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Kubra Neslihan Kurt Oktay, MD — University of Health Sciences, Haydarpasa Numune Training and Research Hospital, Department of Physical Medicine and Rehabilitation
• Study coordinator: Kubra Neslihan Kurt Oktay, MD
• Email: drneslihankurt@gmail.com
• Phone: +905352916609

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.