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Can a fluid injection between muscle layers ease piriformis pain?
NCT ID NCT07813455
First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time
Summary
Researchers are testing whether adding a procedure called interfascial hydrodissection to a standard ultrasound-guided piriformis injection helps adults with piriformis syndrome. The trial enrolls 110 people aged 18 to 70 who have buttock pain and signs of piriformis syndrome. Everyone first receives a lidocaine injection into the piriformis muscle. Those whose pain drops by at least half are randomly assigned to either the injection alone or the injection plus hydrodissection, which uses fluid to separate the gluteus maximus and piriformis muscle layers. Both groups then follow the same home stretching program, and researchers track pain, function, and side effects over three months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- interfascial hydrodissection, a procedure that injects fluid between muscle layers
- What this could lead to
- If it works, this could give doctors a low-risk add-on procedure that eases buttock pain and helps people move more comfortably.
- What could go wrong
- This is a single-center study of 110 people, so results may not apply broadly. Hydrodissection can cause temporary soreness, and any pain relief may fade over time.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 110 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Health Sciences, Haydarpasa Numune Training and Research Hospital, Department of Physical Medicine and Rehabilitation
Istanbul, Uskudar, 34662, Turkey (Türkiye)
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Other studies related to the condition(s) this trial covers.
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