The Importance of Gluteus Maximus Muscle in Patients With Preliminary Diagnosis of Piriformis Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Piriformis Muscle Syndrome, Myofacial Pain Syndromes, Piriformis Syndrome

Intervention / Treatment
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* Diagnostic Test: Ultrasound guided piriformis muscle and gluteus maximus muscle lidocaine injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 Tumors

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gluteus Maximus Group<br>30 patients in the gluteus maximus group will be evaluated with detailed physical examination and special clinical tests. Sensitivity with sonopalpation, piriformis and gluteus maximus thicknesses, echo intensities will be evaluated with ultrasonography. Primarily diagnostic injection test for gluteus maximus muscle is planned for the first group with lidocaine with USG guide. At the first hour after injection full examination will be repeated for all patient and will be evaluated again with Numeric Rating Scale(NRS) at rest, with movement and with deep palpation. If the NRS score persists after the first injection patients will receive a diagnostic lidocaine injection into the piriformis muscle. At the first hour after the second injection, the physical examination and clinical tests of the patients will be repeated, and their pain at rest, with movement and with deep palpation will be evaluated with NRS. | Diagnostic Test: Ultrasound guided piriformis muscle and gluteus maximus muscle lidocaine injection<br>* Ultrasound guided piriformis muscle (piriformis syndrome) and gluteus maximus muscle 5 ml %1 lidocaine injection<br>* Other names: Ultrasound guided piriformis muscle (piriformis syndrome) and gluteus maximus muscle (myofacial pain syndrome of gluteus Maximus muscle) diagnostic lidocaine injection;|
| Active Comparator: Piriformis Muscle group<br>30 patients in the piriformis muscle group will be evaluated with detailed physical examination and special clinical tests. Sensitivity with sonopalpation, piriformis and gluteus maximus thicknesses, echo intensities will be evaluated with ultrasonography. Primarily diagnostic injection test for piriformis muscle (piriformis syndrome) is planned for the first group with lidocaine with USG guide. At the first hour after injection full examination will be repeated for all patient and will be evaluated again with Numeric Rating Scale(NRS) at rest, with movement and with deep palpation. If the NRS score persists after the first injection patients will receive a diagnostic lidocaine injection into the gluteus Maximus muscle. At the first hour after the second injection, the physical examination and clinical tests of the patients will be repeated, and their pain at rest, with movement and with deep palpation will be evaluated with NRS. | Diagnostic Test: Ultrasound guided piriformis muscle and gluteus maximus muscle lidocaine injection<br>* Ultrasound guided piriformis muscle (piriformis syndrome) and gluteus maximus muscle 5 ml %1 lidocaine injection<br>* Other names: Ultrasound guided piriformis muscle (piriformis syndrome) and gluteus maximus muscle (myofacial pain syndrome of gluteus Maximus muscle) diagnostic lidocaine injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Pain via Numeric Rating Scale at 60 Minutes after piriformis muscle/gluteus maximus Injection (first 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. | Baseline, 60 minutes after gluteus maximus injection, 60 minutes after piriformis muscle injection. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Pain via Numeric Rating Scale at 60 Minutes after Second 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. | Baseline, 60 minutes after gluteus maximus injection, 60 minutes after piriformis muscle injection. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Piriformis Muscle Syndrome, Myofacial Pain Syndrome, Ultrasonography, Gluteus Maximus Muscle