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Investigation of the Presence of Piriformis Syndrome Accompanying Lumbar Radiculopathy

Primary Purpose

Piriformis Syndrome, Lumbar Radiculopathy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Ultrasound guided piriformis muscle lidocaine injection
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Piriformis Syndrome focused on measuring Piriformis Syndrome, Lumbar Radiculopathy, Ultrasonography, Diagnostic Injection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Istanbul University-Cerrahpasa

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Piriformis syndrome with lumbar radiculopathy (PSWLR)

Arm Description

All patients (n=40) 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in patient's pain level via Numeric Rating Scale at 1 week and 1 month after injection
Before the injection, the participants' pain at resting, sitting, standing, lying, at night, during activity 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 the 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". One week after the injection, the participant's pain while resting, walking, sitting, lying down and at night will be evaluated with a numerical rating scale and the change in pain scores will be evaluated. Similarly, the change in pain scores during the same activities one month after the injection will also be evaluated. In this way, the amount of relief that may be provided via the piriformis muscle injection in patients having lumbar radiculopathy and piriformis syndrome in short and medium terms will be evaluated.

Full Information

First Posted
March 21, 2022
Last Updated
December 1, 2022
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05392933
Brief Title
Investigation of the Presence of Piriformis Syndrome Accompanying Lumbar Radiculopathy
Official Title
Investigation of the Presence of Piriformis Syndrome Accompanying Lumbar Radiculopathy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 15, 2023 (Anticipated)
Primary Completion Date
March 15, 2023 (Anticipated)
Study Completion Date
April 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Lumbar radiculopathy is a condition in which lumbar spinal nerve roots are affected due to various pathologies. The diagnosis is made clinically by the symptoms and physical examination findings. Most of the time, the diagnosis is supported by imaging methods and electrodiagnostic tests. 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. Similarly, the diagnosis of piriformis syndrome is made clinically based on the patients' history and physical examination. In addition, piriformis muscle injections are an accepted method for the diagnosis of piriformis syndrome. However, the diagnosis of piriformis syndrome is still a controversial issue due to the absence of universally accepted diagnostic criteria, pathognomonic findings, or a gold standard diagnostic method. In this context, many authors have reported that piriformis syndrome is mostly a diagnosis of exclusion. For this reason, the diagnosis of piriformis syndrome is missed in patients with lumbar radiculopathy and these patients may apply to multiple physicians due to their ongoing pain. This can lead to loss of time, financial losses, sensitization and chronic pain in patients and even unnecessary lumbar surgery. Our aim is to investigate whether these two clinical conditions coexist by performing a diagnostic piriformis muscle injection test under ultrasonographic guidance to patients with a diagnosis of lumbar radiculopathy and also with symptoms and signs of piriformis syndrome. The diagnostic injection test into the piriformis muscle has also been reported to have therapeutic effects. Therefore, the second goal of our study is to investigate the therapeutic effect of piriformis muscle injection in patients diagnosed with lumbar radiculopathy and also piriformis syndrome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Piriformis Syndrome, Lumbar Radiculopathy
Keywords
Piriformis Syndrome, Lumbar Radiculopathy, Ultrasonography, Diagnostic Injection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Piriformis syndrome with lumbar radiculopathy (PSWLR)
Arm Type
Experimental
Arm Description
All patients (n=40) 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Ultrasound guided piriformis muscle lidocaine injection
Other Intervention Name(s)
Ultrasound guided piriformis muscle (piriformis syndrome) diagnostic lidocaine injection
Intervention Description
Ultrasound guided piriformis muscle (piriformis syndrome) 5 ml %2 lidocaine injection
Primary Outcome Measure Information:
Title
Change from baseline pain at 30 minutes after piriformis muscle injection
Description
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.
Time Frame
Baseline, 30 minutes after piriformis muscle injection
Secondary Outcome Measure Information:
Title
Change in patient's pain level via Numeric Rating Scale at 1 week and 1 month after injection
Description
Before the injection, the participants' pain at resting, sitting, standing, lying, at night, during activity 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 the 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". One week after the injection, the participant's pain while resting, walking, sitting, lying down and at night will be evaluated with a numerical rating scale and the change in pain scores will be evaluated. Similarly, the change in pain scores during the same activities one month after the injection will also be evaluated. In this way, the amount of relief that may be provided via the piriformis muscle injection in patients having lumbar radiculopathy and piriformis syndrome in short and medium terms will be evaluated.
Time Frame
Baseline, one week after piriformis muscle injection, one month after piriformis muscle injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yasar Burak Topcu
Phone
+905332056727
Email
buraktopcu1905@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tugce Ozekli Misirlioglu
Phone
+905326421357
Email
tozeklim@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasar Burak Topcu
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tugce Ozekli Misirlioglu
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul University-Cerrahpasa
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasar Burak Topcu
Phone
+905332056727
Email
buraktopcu1905@hotmail.com
First Name & Middle Initial & Last Name & Degree
Tugce Ozekli Misirlioglu
Phone
+905326421357
Email
tozeklim@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17445735
Citation
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Results Reference
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19762151
Citation
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.
Results Reference
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PubMed Identifier
31102324
Citation
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.
Results Reference
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PubMed Identifier
23684470
Citation
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.
Results Reference
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PubMed Identifier
27644428
Citation
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.
Results Reference
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PubMed Identifier
20596735
Citation
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.
Results Reference
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PubMed Identifier
11887107
Citation
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.
Results Reference
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PubMed Identifier
23893704
Citation
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.
Results Reference
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PubMed Identifier
22931697
Citation
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.
Results Reference
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PubMed Identifier
15062719
Citation
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.
Results Reference
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PubMed Identifier
25794202
Citation
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.
Results Reference
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PubMed Identifier
31741344
Citation
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Results Reference
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Citation
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Results Reference
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Investigation of the Presence of Piriformis Syndrome Accompanying Lumbar Radiculopathy

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