Investigation of the Presence of Piriformis Syndrome Accompanying Lumbar Radiculopathy

NCT05392933 | Completed

• 1 other identifier: IstanbulUC-YasarBurakTOPCU-001
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Piriformis syndrome is a neuromuscular disorder that is characterized by piriformis muscle tenderness, hip, and leg pain, and may be accompanied by compression or irritation of the sciatic nerve under the piriformis muscle. There are many studies in the literature to establish diagnostic criteria for piriformis syndrome, and there is still no clear consensus on these criteria. However, cases with lumbar radiculopathy were accepted as exclusion criteria in all these studies. The aim of our study is to investigate whether lumbar radiculopathy and piriformis syndrome can coexist. For this reason, a diagnostic piriformis muscle injection under ultrasonography guidance is planned for patients with lumbar radiculopathy who also have a prediagnosis of piriformis syndrome clinically.

Conditions

Piriformis Syndrome; Lumbar Radiculopathy

Keywords

Piriformis Syndrome; Lumbar Radiculopathy; Ultrasonography; Diagnostic Injection

Outcome Measures

Primary Outcomes (1)

• Change from baseline pain at 30 minutes after piriformis muscle injection

  After the piriformis muscle injection, the percentage of relief in patient's symptoms will be questioned. It has been reported that 50% or more reduction in the patient's complaints after injecting the local anesthetic agent into the piriformis muscle, with or without steroids, is diagnostic for piriformis syndrome. Therefore, patients with at least 50% reduction in post-injection complaints will be diagnosed with piriformis syndrome.

  Baseline, 30 minutes after piriformis muscle injection

Secondary Outcomes (1)

• Change in patient's pain level via Numeric Rating Scale at 1 week and 1 month after injection

  Baseline, one week after piriformis muscle injection, one month after piriformis muscle injection

Study Arms (1)

Piriformis syndrome with lumbar radiculopathy (PSWLR)

EXPERIMENTAL

All patients (n=39) will be evaluated with detailed physical examination and special clinical tests for both lumbar radiculopathy and piriformis syndrome. If patients have lumbar magnetic resonance imaging or electromyography results, they will be recorded to confirm the diagnosis of lumbar radiculopathy. The patients who have the final diagnosis of lumbar radiculopathy and prediagnosis of piriformis syndrome will be evaluated for the pain scores (pain at resting, sitting, standing, lying, at night and during activity) using numeric rating scale. Then, an ultrasound guided piriformis muscle injection will be performed. The patients will be kept under observation for 30 minutes afterwards and the percentage of their pain relief will be recorded. The patients whose pain resolves at least 50% from the baseline after the injection will be diagnosed as piriformis syndrome and will be reevaluated one week and one month after the injection and the changes in the pain scores will be recorded.

Diagnostic Test: Ultrasound guided piriformis muscle lidocaine injection

Interventions

Ultrasound guided piriformis muscle lidocaine injection DIAGNOSTIC_TEST

Ultrasound guided piriformis muscle (piriformis syndrome) 5 ml %2 lidocaine injection

Also known as: Ultrasound guided piriformis muscle (piriformis syndrome) diagnostic lidocaine injection

Piriformis syndrome with lumbar radiculopathy (PSWLR)

Eligibility Criteria

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

You may qualify if:

• Aged over 18 years
• Having clinical symptoms and signs of L4/L5/S1 radiculopathy which may be supported by imaging and/or electrodiagnostic evaluation
• Having tenderness at the piriformis muscle

You may not qualify if:

• Injection history at the lumbar, hip, gluteal region in the last 6 months
• Operation history at the lumbar and/ or hip region
• History of inflammatory rheumatic disease
• History of infectious disease
• History of bleeding disorder
• History of anticoagulation use
• Uncontrolled diabetes mellitus or hypertension
• History of neurological disease
• Being in gestational or lactational period
• Noncompensated chronic heart/liver/renal deficiency, or vascular/tumoral disease
• Active psychiatric disease
• History of allergic reaction to the substance to be applied as local anesthetic

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, 34098, Turkey (Türkiye)

Location

Related Publications (13)

• Tarulli AW, Raynor EM. Lumbosacral radiculopathy. Neurol Clin. 2007 May;25(2):387-405. doi: 10.1016/j.ncl.2007.01.008.

  PMID: 17445735 BACKGROUND

• Bogduk N. On the definitions and physiology of back pain, referred pain, and radicular pain. Pain. 2009 Dec 15;147(1-3):17-9. doi: 10.1016/j.pain.2009.08.020. Epub 2009 Sep 16. No abstract available.

  PMID: 19762151 BACKGROUND

• 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

• Michel F, Decavel P, Toussirot E, Tatu L, Aleton E, Monnier G, Garbuio P, Parratte B. Piriformis muscle syndrome: diagnostic criteria and treatment of a monocentric series of 250 patients. Ann Phys Rehabil Med. 2013 Jul;56(5):371-83. doi: 10.1016/j.rehab.2013.04.003. Epub 2013 Apr 25.

  PMID: 23684470 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

• 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

• Fishman LM, Dombi GW, Michaelsen C, Ringel S, Rozbruch J, Rosner B, Weber C. Piriformis syndrome: diagnosis, treatment, and outcome--a 10-year study. Arch Phys Med Rehabil. 2002 Mar;83(3):295-301. doi: 10.1053/apmr.2002.30622.

  PMID: 11887107 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

• Miller TA, White KP, Ross DC. The diagnosis and management of Piriformis Syndrome: myths and facts. Can J Neurol Sci. 2012 Sep;39(5):577-83. doi: 10.1017/s0317167100015298.

  PMID: 22931697 BACKGROUND

• Papadopoulos EC, Khan SN. Piriformis syndrome and low back pain: a new classification and review of the literature. Orthop Clin North Am. 2004 Jan;35(1):65-71. doi: 10.1016/S0030-5898(03)00105-6.

  PMID: 15062719 BACKGROUND

• Misirlioglu TO, Akgun K, Palamar D, Erden MG, Erbilir T. Piriformis syndrome: comparison of the effectiveness of local anesthetic and corticosteroid injections: a double-blinded, randomized controlled study. Pain Physician. 2015 Mar-Apr;18(2):163-71.

  PMID: 25794202 BACKGROUND

• Terlemez R, Ercalik T. Effect of piriformis injection on neuropathic pain. Agri. 2019 Nov;31(4):178-182. doi: 10.14744/agri.2019.34735.

  PMID: 31741344 BACKGROUND

• Lauder TD. Physical examination signs, clinical symptoms, and their relationship to electrodiagnostic findings and the presence of radiculopathy. Phys Med Rehabil Clin N Am. 2002 Aug;13(3):451-67. doi: 10.1016/s1047-9651(02)00006-2.

  PMID: 12380545 BACKGROUND

MeSH Terms

Conditions

Piriformis Muscle Syndrome; Radiculopathy

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

Study Officials

• Yasar Burak Topcu

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

• Tugce Ozekli Misirlioglu

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: May 26, 2022
• Study Start: January 15, 2023
• Primary Completion: January 15, 2024
• Study Completion: June 15, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)