Clinical trial NCT05271071: The Importance of Gluteus Maximus Muscle in Patients With Preliminary Diagnosis of Piriformis Syndrome
Official title: The Importance of Gluteus Maximus Muscle in Patients With Preliminary Diagnosis of Piriformis Syndrome: Prospective, Randomized, Single-Blind, Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Piriformis Muscle Syndrome
Myofacial Pain Syndromes
Piriformis Syndrome
Keywords: Piriformis Muscle Syndrome
Myofacial Pain Syndrome
Ultrasonography
Gluteus Maximus Muscle
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Pain via Numeric Rating Scale at 60 Minutes after piriformis muscle/gluteus maximus Injection (first injection)
timeFrame: Baseline, 60 minutes after gluteus maximus injection, 60 minutes after piriformis muscle injection.
Secondary outcomes:
measure: Change from Baseline Pain via Numeric Rating Scale at 60 Minutes after Second Injection
timeFrame: Baseline, 60 minutes after gluteus maximus injection, 60 minutes after piriformis muscle injection.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University- Cerrahpaşa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Bilge Cakir
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University - Cerrahpasa
name: Kenan Akgun
role: STUDY_DIRECTOR
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