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临床试验/NCT07326982
NCT07326982尚未招募不适用

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.

Istanbul University - Cerrahpasa1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2026年3月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
42
试验地点
1
主要终点
Pain Intensity Assessed by Numeric Rating Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

Ultrasound-Guided Interfascial Hydrodissection

Experimental

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

干预措施: Ultrasound-Guided Interfascial Hydrodissection (Procedure)

Ultrasound-guided gluteus maximus dry needling

Active Comparator

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

干预措施: Ultrasound-Guided Gluteus Maximus Dry Needling (Procedure)

结局指标

主要结局

Pain Intensity Assessed by Numeric Rating Scale

时间窗: 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.

次要结局

  • Pain Intensity Assessed by Numeric Rating Scale(1 month after the intervention)
  • Pain Intensity Assessed by Numeric Rating Scale(1 week after the intervention)

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Busra Nur Aslantas

Resident Physician, Physical Medicine and Rehabilitation Department

Istanbul University - Cerrahpasa

研究点 (1)

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