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

NCT05271071 | Completed

• 1 other identifier: IstanbulUC-BilgeCAKIR-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Piriformis Muscle Syndrome; Myofacial Pain Syndromes; Piriformis Syndrome

Keywords

Piriformis Muscle Syndrome; Myofacial Pain Syndrome; Ultrasonography; Gluteus Maximus Muscle

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (2)

Gluteus Maximus Group

ACTIVE COMPARATOR

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

Piriformis Muscle group

ACTIVE COMPARATOR

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

Interventions

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

Also known as: Ultrasound guided piriformis muscle (piriformis syndrome) and gluteus maximus muscle (myofacial pain syndrome of gluteus Maximus muscle) diagnostic lidocaine injection

Gluteus Maximus Group; Piriformis Muscle group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University- Cerrahpaşa

Istanbul, 34098, Turkey (Türkiye)

Location

Related Publications (13)

• Probst D, Stout A, Hunt D. Piriformis Syndrome: A Narrative Review of the Anatomy, Diagnosis, and Treatment. PM R. 2019 Aug;11 Suppl 1:S54-S63. doi: 10.1002/pmrj.12189. Epub 2019 Jul 22.

  PMID: 31102324 BACKGROUND

• Kirschner JS, Foye PM, Cole JL. Piriformis syndrome, diagnosis and treatment. Muscle Nerve. 2009 Jul;40(1):10-8. doi: 10.1002/mus.21318.

  PMID: 19466717 BACKGROUND

• Cass SP. Piriformis syndrome: a cause of nondiscogenic sciatica. Curr Sports Med Rep. 2015 Jan;14(1):41-4. doi: 10.1249/JSR.0000000000000110.

  PMID: 25574881 BACKGROUND

• Hopayian K, Danielyan A. Four symptoms define the piriformis syndrome: an updated systematic review of its clinical features. Eur J Orthop Surg Traumatol. 2018 Feb;28(2):155-164. doi: 10.1007/s00590-017-2031-8. Epub 2017 Aug 23.

  PMID: 28836092 BACKGROUND

• Hopayian K, Song F, Riera R, Sambandan S. The clinical features of the piriformis syndrome: a systematic review. Eur Spine J. 2010 Dec;19(12):2095-109. doi: 10.1007/s00586-010-1504-9. Epub 2010 Jul 3.

  PMID: 20596735 BACKGROUND

• Jankovic D, Peng P, van Zundert A. Brief review: piriformis syndrome: etiology, diagnosis, and management. Can J Anaesth. 2013 Oct;60(10):1003-12. doi: 10.1007/s12630-013-0009-5. Epub 2013 Jul 27.

  PMID: 23893704 BACKGROUND

• Hermann W. [The piriformis syndrome-a special indication for botulinum toxin]. Nervenarzt. 2020 Feb;91(2):99-106. doi: 10.1007/s00115-020-00866-4. German.

  PMID: 32020236 BACKGROUND

• Kuncewicz E, Gajewska E, Sobieska M, Samborski W. Piriformis muscle syndrome. Ann Acad Med Stetin. 2006;52(3):99-101; discussion 101.

  PMID: 17385355 BACKGROUND

• Siddiq MA, Hossain MS, Uddin MM, Jahan I, Khasru MR, Haider NM, Rasker JJ. Piriformis syndrome: a case series of 31 Bangladeshi people with literature review. Eur J Orthop Surg Traumatol. 2017 Feb;27(2):193-203. doi: 10.1007/s00590-016-1853-0. Epub 2016 Sep 19.

  PMID: 27644428 BACKGROUND

• Borg-Stein J, Iaccarino MA. Myofascial pain syndrome treatments. Phys Med Rehabil Clin N Am. 2014 May;25(2):357-74. doi: 10.1016/j.pmr.2014.01.012. Epub 2014 Mar 17.

  PMID: 24787338 BACKGROUND

• Money S. Pathophysiology of Trigger Points in Myofascial Pain Syndrome. J Pain Palliat Care Pharmacother. 2017 Jun;31(2):158-159. doi: 10.1080/15360288.2017.1298688. Epub 2017 Apr 5.

  PMID: 28379050 BACKGROUND

• Saxena A, Chansoria M, Tomar G, Kumar A. Myofascial pain syndrome: an overview. J Pain Palliat Care Pharmacother. 2015 Mar;29(1):16-21. doi: 10.3109/15360288.2014.997853. Epub 2015 Jan 5.

  PMID: 25558924 BACKGROUND

• Gerwin RD. Diagnosis of myofascial pain syndrome. Phys Med Rehabil Clin N Am. 2014 May;25(2):341-55. doi: 10.1016/j.pmr.2014.01.011. Epub 2014 Mar 18.

  PMID: 24787337 BACKGROUND

MeSH Terms

Conditions

Piriformis Muscle Syndrome; Facial Neuralgia

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases

Study Officials

• Bilge Cakir

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

• Kenan Akgun

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 8, 2022
• Study Start: March 14, 2022
• Primary Completion: April 15, 2022
• Study Completion: May 15, 2022
• Last Updated: June 28, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)