跳至主要内容
临床试验/NCT05271071
NCT05271071已完成不适用

The Importance of Gluteus Maximus Muscle in Patients With Preliminary Diagnosis of Piriformis Syndrome: Prospective, Randomized, Single-Blind, Crossover Study

Istanbul University - Cerrahpasa (IUC)2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年3月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Change from Baseline Pain via Numeric Rating Scale at 60 Minutes after piriformis muscle/gluteus maximus Injection (first injection)

研究概览

简要总结

Literature shows different pathologies or combination pathologies can cause gluteal region pain and it can be difficult to diagnose. Piriformis syndrome is one of the cause of gluteal region pain, symptoms of myofascial pain syndrome affected gluteus maximus muscle may masquerade as piriformis muscle syndrome or both syndrome can be seen together. The aim of this study is diagnosis myofascial pain syndrome of gluteus maximus muscle and piriformis syndrome by physical examination, special clinical tests and ultrasound guided diagnostic injection test in patients presenting with gluteal pain and evaluate the coexistence of both syndromes.

详细描述

Piriformis syndrome is a painful clinical picture caused by entrapment of the sciatic nerve by the piriformis muscle at the exit of the pelvis, which causes pain in the gluteal region. It is characterized by symptoms of pain and numbness radiating from the thigh to the leg along the hip and sciatic trace. Compression/irritation of the sciatic nerve in or around the piriformis muscle constitutes the neuropathic component of the syndrome. Myofascial pain of the piriformis muscle is the primary cause of the somatic component of the syndrome. Various causes have been reported: congenital anomalies of piriformis muscle or sciatic nerve, trauma, overuse, muscle hypertrophy, shortening of the muscle, infection within the muscle, and leg length discrepancy. History, physical examination and ultrasound guided diagnostic injection test are key elements for the diagnosis.

Another cause of pain in the gluteal region is myofascial pain syndrome of gluteus maximus muscle. Myofascial pain syndrome is a largely underdiagnosed and undertreated entity. Prevalence varies from 30 to 93% among the persons with musculoskeletal pain. Myofascial pain syndrome is a syndrome characterized by acute or chronic regional pain originating from localized trigger points in the muscle and fascia. Traumatic events, muscular overloads, psychological stress, and systemic pathology may lead to development of one or more palpable bands or trigger points. Myofascial pain syndrome affecting the gluteus maximus muscle causes pain in the medial and lower parts of the muscle; It is characterized by pain that usually radiates throughout the hip and sometimes into the coccygeal region. The diagnosis of myofascial pain syndrome is based on a pertinent history and physical examination.

The purpose of the study is; to evaluate the myofascial pain syndrome of gluteus maximus muscle and piriformis syndrome with physical examination, special clinical tests, ultrasonographic examinations and, to confirm the presence of myofascial pain syndrome of gluteus maximus muscle accompanying piriformis syndrome with the evaluation of clinical findings after the gluteus maximus and piriformis muscle diagnostic injections.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18-65 years
  • Had unilateral hip pain and/or leg pain
  • Had Positive trigger point or taut band or pain with pression in piriformis muscle
  • Patients whose informed consent was obtained for participation in the study

排除标准

  • History of hip surgery
  • History of spinal surgery
  • Clinical diagnosis of Inflammatory rheumatic diseases
  • History of spinal or pelvic fracture
  • Clinical diagnosis of osteoarthritis or history of fracture of the lower extremities
  • Had uncontrolled diabetes
  • Pregnancy or breastfeeding
  • Had allergy to lidocaine
  • Had gluteal injection in the previous 6 months
  • Had anticoagulant or antiplatelet treatment
  • Had skin infection at the site of needle entry
  • Had radiculopathy caused by lumbar disc pathology
  • Had neurological disease

结局指标

主要结局

Change from Baseline Pain via Numeric Rating Scale at 60 Minutes after piriformis muscle/gluteus maximus Injection (first injection)

时间窗: Baseline, 60 minutes after gluteus maximus injection, 60 minutes after piriformis muscle injection.

Pain of the participants will be assessed by one of the most commonly used pain scale "numerical rating scale". It is numeric version of visual analog scale in which a patient selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing "no pain" to '10' representing "pain as bad as you can imagine". Participant is asked to indicate rates of their pain on the day of presentation during resting, during function and physical examination as a baseline and, 60 minutes after gluteus maximus injection for each, 60 minutes after piriformis muscle injection for each.

次要结局

  • Change from Baseline Pain via Numeric Rating Scale at 60 Minutes after Second Injection(Baseline, 60 minutes after gluteus maximus injection, 60 minutes after piriformis muscle injection.)

研究者

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

Bilge Cakir

Principal Investigator

Istanbul University - Cerrahpasa (IUC)

研究点 (2)

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