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NCT Number: NCT07326982

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine

Istanbul, Turkey (Türkiye)

Location contact

busra nur aslantas, MD

CONTACT

[email protected]

+905075985562

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Ultrasound-Guided Interfascial Hydrodissection

Procedure

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

Ultrasound-Guided Gluteus Maximus Dry Needling

Procedure

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

Primary outcomes

  1. Pain Intensity Assessed by Numeric Rating Scale

    Time frame: 3 months after the intervention

    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.

Secondary outcomes

  1. Pain Intensity Assessed by Numeric Rating Scale

    Time frame: 1 week after the intervention

    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.

  2. Pain Intensity Assessed by Numeric Rating Scale

    Time frame: 1 month after the intervention

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Busra Nur Aslantas, MD

CONTACT

[email protected]

+905075985562

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study 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.

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 8, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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