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

NCT07326982 | Not Yet Recruiting

• 1 other identifier: CTFPIRHD2025
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Piriformis Syndrome; Gluteus Maximus Myofascial Pain

Keywords

Interfascial hydrodissection; Gluteal pain; Ultrasound-guided injection

Outcome Measures

Primary Outcomes (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.

  3 months after the intervention

Secondary Outcomes (2)

• Pain Intensity Assessed by Numeric Rating Scale

  1 week after the intervention

• Pain Intensity Assessed by Numeric Rating Scale

  1 month after the intervention

Study Arms (2)

Ultrasound-Guided Interfascial Hydrodissection

EXPERIMENTAL

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

Procedure: Ultrasound-Guided Interfascial Hydrodissection

Ultrasound-guided gluteus maximus dry needling

ACTIVE COMPARATOR

Participants receive ultrasound-guided dry needling applied to the gluteus maximus muscle.

Procedure: Ultrasound-Guided Gluteus Maximus Dry Needling

Interventions

Ultrasound-Guided Interfascial Hydrodissection PROCEDURE

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

Ultrasound-Guided Interfascial Hydrodissection

Ultrasound-Guided Gluteus Maximus Dry Needling PROCEDURE

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

Ultrasound-guided gluteus maximus dry needling

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine

Istanbul, Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Piriformis Muscle Syndrome

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pelvic Pain

Central Study Contacts

Busra Nur Aslantas, MD

CONTACT

+905075985562; busra.kaya1@iuc.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician, Physical Medicine and Rehabilitation Department

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 8, 2026
• Study Start: March 26, 2026
• Primary Completion (Estimated): June 28, 2026
• Study Completion (Estimated): September 28, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

TU (1)