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Piriformis SyndromeNCT07326982

Ultrasound-Guided Interfascial Hydrodissection for Gluteal Myofascial Pain in Piriformis Syndrome: A Prospective Study

A study testing Ultrasound-Guided Interfascial Hydrodissection and Ultrasound-Guided Gluteus Maximus Dry Needling in people with Piriformis Syndrome and Gluteus Maximus Myofascial Pain, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This randomized, double-blind prospective trial investigates whether ultrasound-guided interfascial hydrodissection using 10% dextrose is more effective than dry needling in treating gluteal myofascial pain coexisting with piriformis syndrome. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Ultrasound-Guided Interfascial Hydrodissection and Ultrasound-Guided Gluteus Maximus Dry Needling
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteTurkey (Türkiye)
Study dates
26 Mar 2026to 28 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged 18 to 75 years
  • Buttock pain with or without radiation to the lower extremity
  • Ability to understand and provide written informed consent

Who cannot join

  • Active lumbar radiculopathy
  • History of hip joint pathology or prior hip surgery
  • Previous injection or dry needling treatment to the gluteal region within the last 3 months
  • Coagulation disorders or use of anticoagulant therapy
  • Pregnancy
  • Local infection at the injection site
  • Inability to complete the study protocol or attend follow-up visits.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Busra Nur Aslantas, MD contact

+905075985562

busra.kaya1@iuc.edu.tr

Turkey (Türkiye)1 site
  • Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine

    Istanbul, Istanbul

    busra nur aslantas, MD, +905075985562, busra.kaya1@iuc.edu.tr

Other trials in Turkey (Türkiye)

About this study

Official title: Efficacy of Ultrasound-Guided Interfascial Hydrodissection for Myofascial Pain Syndrome of the Gluteus Maximus in Patients With Piriformis Syndrome: A Double-Blind Randomized Controlled Trial.

This randomized, double-blind prospective trial investigates whether ultrasound-guided interfascial hydrodissection using 10% dextrose is more effective than dry needling in treating gluteal myofascial pain coexisting with piriformis syndrome. Following diagnostic piriformis injection response, eligible patients will be randomized into two treatment arms and followed at 1 hour, 1 week, 1 month, and 3 months. The primary hypothesis is that interfascial hydrodissection will provide superior long-term analgesic outcomes due to fascial separation, neuromodulation, and nociceptor suppression.

Read the detailed description

Piriformis syndrome (PS) is a neuromuscular condition characterized by compression or irritation of the sciatic nerve at the piriformis muscle level. Patients frequently present with unilateral gluteal pain that worsens with prolonged sitting, hip movement, or palpation over the piriformis locus. Although the neuropathic component of PS is attributed to sciatic nerve irritation, the somatic pain component is believed to arise from myofascial dysfunction within gluteal structures, particularly the piriformis muscle.

Recent clinical observations indicate that many patients diagnosed with PS also exhibit features of gluteus maximus myofascial pain syndrome (GM-MPS). The gluteus maximus muscle has a large fascial interface with the piriformis muscle, and nociceptive stimulation originating from this interface may contribute to persistent gluteal pain in PS. Despite this, the fascial contribution to symptom persistence remains poorly investigated, and therapeutic interventions are largely directed toward the piriformis alone.

Interfascial hydrodissection is an emerging ultrasound-guided technique in which liquid is injected between tissue planes to mechanically separate fascial layers, improve gliding, and modulate sensory nociceptive fibers. Dextrose solutions have been increasingly used in ultrasound-guided interfascial injections based on their proposed neuromodulatory and regenerative effects. However, evidence regarding its long-term efficacy in gluteal myofascial pain, particularly when coexisting with PS, is limited.

This prospective, randomized, double-blind clinical trial aims to evaluate the therapeutic effectiveness of interfascial hydrodissection using 10% dextrose solution between the gluteus maximus and piriformis muscles in patients with PS diagnosed through positive diagnostic injection response. Patients with ≥50% pain reduction one hour after diagnostic piriformis injection will be randomized into two treatment groups. Randomization will be performed by an independent co-investigator using a pre-prepared 1:1 allocation list. Outcome assessment will be conducted by an investigator blinded to treatment allocation. Patients will then be assigned to one of the following treatment groups: (1) ultrasound-guided interfascial hydrodissection and (2) dry needling of the gluteus maximus muscle.Both interventions will be performed under ultrasound guidance to ensure accuracy and standardization.

Outcome assessment will include numerical pain scoring, percentage pain reduction, and clinical improvement at one hour, one week, one month, and three months post-intervention. The first assessor will be blinded to treatment allocation, ensuring independent measurement of outcomes. It is hypothesized that interfascial hydrodissection will provide superior long-term pain relief compared with dry needling by separating adhered fascial planes, improving local mobility, and reducing nociceptive drive through dextrose-mediated neuromodulation.

If successful, this trial will provide the first structured evidence evaluating the role of gluteus maximus-piriformis fascial interface treatment in PS and may identify an overlooked pain generator in this common syndrome. Results could expand therapeutic options for PS, support broader application of interfascial hydrodissection, and contribute to clinical understanding of fascial pain mechanisms.

Being tested
Ultrasound-Guided Interfascial Hydrodissection, Ultrasound-Guided Gluteus Maximus Dry Needling
Keywords
Interfascial hydrodissection, Gluteal pain, Ultrasound-guided injection
Medical subject headings
Piriformis Muscle Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound-Guided Interfascial HydrodissectionProcedure or surgery

    Ultrasound-guided interfascial hydrodissection is performed in the interfascial plane between the gluteus maximus and piriformis muscles.

  • Ultrasound-Guided Gluteus Maximus Dry NeedlingProcedure or surgery

    Ultrasound-guided dry needling is performed on the gluteus maximus muscle without fluid administration.

Study groups in NCT07326982
Study groupRoleWhat they receive
Ultrasound-Guided Interfascial HydrodissectionExperimentalUltrasound-guided interfascial hydrodissection is performed in the interfascial space between the gluteus maximus and piriformis muscles.
Receives: Procedure: Ultrasound-Guided Interfascial Hydrodissection
Ultrasound-guided gluteus maximus dry needlingActive comparatorParticipants receive ultrasound-guided dry needling applied to the gluteus maximus muscle.
Receives: Procedure: Ultrasound-Guided Gluteus Maximus Dry Needling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Intensity Assessed by Numeric Rating Scale

    Pain intensity is assessed using the Numeric Rating Scale (NRS, 0-10) for pain at rest, during activity, at night, while standing, sitting, lying down, and for overall pain.

    Measured: 3 months after the intervention

Secondary outcomes (2)
  1. Pain Intensity Assessed by Numeric Rating Scale

    Pain intensity is assessed using the Numeric Rating Scale (NRS, 0-10) for pain at rest, during activity, at night, while standing, sitting, lying down, and for overall pain.

    Measured: 1 week after the intervention

  2. Pain Intensity Assessed by Numeric Rating Scale

    Pain intensity is assessed using the Numeric Rating Scale (NRS, 0-10) for pain at rest, during activity, at night, while standing, sitting, lying down, and for overall pain.

    Measured: 1 month after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2026
  2. Study start26 Mar 2026 (estimated)
  3. Primary completion28 Jun 2026 (estimated)
  4. Study completion28 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07326982
Sponsor's protocol ID
CTFPIRHD2025
Status last verified
Mar 2026
First submitted
24 Dec 2025
Last updated
13 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Individual participant data sharing has not been decided at this stage. Although ethical approval for the study has been obtained, any potential data sharing will be considered in the future upon reasonable request and in accordance with participant consent and institutional policies.

Publications

  • Tantanatip A, Patisumpitawong W, Lee S. Comparison of the Effects of Physiologic Saline Interfascial and Lidocaine Trigger Point Injections in Treatment of Myofascial Pain Syndrome: A Double-Blind Randomized Controlled Trial. Arch Rehabil Res Clin Transl. 2021 Mar 9;3(2):100119. doi: 10.1016/j.arrct.2021.100119. eCollection 2021 Jun.

    PubMed 34179755
  • Misirlioglu TO, Akgun K, Palamar D, Erden MG, Erbilir T. Piriformis syndrome: comparison of the effectiveness of local anesthetic and corticosteroid injections: a double-blinded, randomized controlled study. Pain Physician. 2015 Mar-Apr;18(2):163-71.

    PubMed 25794202
  • Kaga M, Ueda T. Effectiveness of Hydro-Dissection of the Piriformis Muscle Plus Low-Dose Local Anesthetic Injection for Piriformis Syndrome: A Report of 2 Cases. Am J Case Rep. 2022 Feb 6;23:e935346. doi: 10.12659/AJCR.935346.

    PubMed 35124689

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound-Guided Interfascial Hydrodissection and Ultrasound-Guided Gluteus Maximus Dry Needling in people with Piriformis Syndrome and Gluteus Maximus Myofascial Pain, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Busra Nur Aslantas, MD (+905075985562, busra.kaya1@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Intensity Assessed by Numeric Rating Scale (time frame: 3 months after the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07326982, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.

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