Ultrasound-Guided Interfascial Hydrodissection for Gluteal Myofascial Pain in Piriformis Syndrome: A Prospective Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ultrasound-Guided Interfascial Hydrodissection, Ultrasound-Guided Gluteus Maximus Dry Needling.
- Who it may be relevant to
- Registry conditions: Piriformis Syndrome, Gluteus Maximus Myofascial Pain. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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.
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.
Interventions
- Procedure Ultrasound-Guided Interfascial Hydrodissection
Ultrasound-guided interfascial hydrodissection is performed in the interfascial plane between the gluteus maximus and piriformis muscles. - Procedure Ultrasound-Guided Gluteus Maximus Dry Needling
Ultrasound-guided dry needling is performed on the gluteus maximus muscle without fluid administration.
Primary outcome measures
- Pain Intensity Assessed by Numeric Rating Scale [Time frame: 3 months after the intervention]
Secondary outcome measures (2)
- Pain Intensity Assessed by Numeric Rating Scale [Time frame: 1 week after the intervention]
- Pain Intensity Assessed by Numeric Rating Scale [Time frame: 1 month after the intervention]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine — Istanbul
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. PMID 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. PMID 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. PMID 35124689
Identifiers
NCT: NCT07326982 · CTFPIRHD2025