Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine
Istanbul, Turkey (Türkiye)
NCT Number: NCT07326982
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Not applicable
Istanbul, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ultrasound-guided interfascial hydrodissection is performed in the interfascial plane between the gluteus maximus and piriformis muscles.
Ultrasound-guided dry needling is performed on the gluteus maximus muscle without fluid administration.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Istanbul University - Cerrahpasa
Other
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.
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.
Published trials that share one or more normalized conditions with this study.
NCT07661485
Congenital Abnormalities, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Faisalābad, Punjab Province, Pakistan
View Trial DetailsNCT07646314
Mononeuropathies, Nerve Compression Syndromes
Lahore, Punjab Province, Pakistan
View Trial DetailsNCT07473349
Gluteal Pain, Mononeuropathies
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07674433
Congenital Abnormalities, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Kahramanmaraş, onikişubat, Turkey (Türkiye)
View Trial Details