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Completed

NCT Number: NCT05271071

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound guided piriformis muscle and gluteus maximus muscle lidocaine injection

Diagnostic Test

Ultrasound guided piriformis muscle (piriformis syndrome) and gluteus maximus muscle 5 ml %1 lidocaine injection

Other names: Ultrasound guided piriformis muscle (piriformis syndrome) and gluteus maximus muscle (myofacial pain syndrome of gluteus Maximus muscle) diagnostic lidocaine injection

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Change from Baseline Pain via Numeric Rating Scale at 60 Minutes after Second Injection

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 8, 2022
Registry last updated
Jun 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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