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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04600024
Other study ID # FSMEAH
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 20, 2018
Est. completion date June 18, 2020

Study information

Verified date September 2020
Source Fatih Sultan Mehmet Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this case-control study, 23 patients diagnosed as PS by diagnostic injection with ultrasound guidance were selected as the study group. 22 patients who were excluded from the diagnosis of PS and had anteroposterior (AP) direct radiographic imaging were evaluated as the control group. On the AP Pelvic graph, the femoral neck-shaft angle, the distances between predetermined bony landmarks were measured blindly without knowing the diagnosis, and the findings were compared statistically. This study aims to evaluate whether the anatomical structure of the pelvis predisposes to the etiopathogenesis of the piriformis syndrome.


Description:

Piriformis syndrome (PS) is a neuromuscular disorder consisting of pain and symptoms caused by compression of the sciatic nerve and other structures that pass under the piriformis muscle (PM). Due to difficulties in diagnosis, PS is confused with other pathologies such as lumbar disc pathology, lumbosacral radiculopathy, and sacroiliac dysfunction. As a result, patients are exposed to unnecessary and ineffective treatments, even surgery. The main problems in the PS diagnosis are the absence of objective physical examination findings, radiological findings, and a clear etiology. When the pathophysiology and etiology of PS are considered, there is no identifiable cause in most patients. Previous studies suggest that trauma, anatomical variations, and the trigger point in the muscle may cause PS. No study in the literature radiologically examined the pelvis or hip bone morphological features in PS to the best of our knowledge. This study aims to determine whether pelvic or hip bone morphology features pose a risk for PS in this study.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date June 18, 2020
Est. primary completion date March 18, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility For Piriformis syndrome group (study group); Inclusion Criteria: - A dramatic relief of pain following piriformis muscle local anesthetic injection Exclusion Criteria: - Having a neurological deficiency - Having lumbar, sacroiliac, hip, and thoracolumbar pathology (inflammatory or degenerative) - Operation history at the lumbar and hip region - Being in the gestational or lactational period - Body mass index of greater than 35 - History of inflammatory or infectious disease - Active psychiatric illness, severe systemic, vascular or malign disease For the control group Inclusion criteria: -Having Anteroposterior pelvic radiographs for other medical reasons Exclusion criteria: - Having a present piriformis syndrome or a history of piriformis syndrome - Having a neurological deficiency - Having lumbar, sacroiliac, hip, and thoracolumbar pathology (inflammatory or degenerative) - Operation history at the lumbar and hip region - Being in the gestational or lactational period - Body mass index of greater than 35 - History of inflammatory or infectious disease - Active psychiatric illness, severe systemic, vascular or malign disease

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Ultrasound guided diagnostic injection
4 cc lidocaine %2 injection into the piriformis muscle was performed for the diagnosis of piriformis syndrome. It was performed by the ultrasound-guidance to increase the accuracy of the injection.

Locations

Country Name City State
Turkey Fatih Sultan Mehmet Research and Traning Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Fatih Sultan Mehmet Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (26)

Benson ER, Schutzer SF. Posttraumatic piriformis syndrome: diagnosis and results of operative treatment. J Bone Joint Surg Am. 1999 Jul;81(7):941-9. — View Citation

Boese CK, Frink M, Jostmeier J, Haneder S, Dargel J, Eysel P, Lechler P. The Modified Femoral Neck-Shaft Angle: Age- and Sex-Dependent Reference Values and Reliability Analysis. Biomed Res Int. 2016;2016:8645027. doi: 10.1155/2016/8645027. Epub 2016 Dec 1 — View Citation

Bredella MA, Azevedo DC, Oliveira AL, Simeone FJ, Chang CY, Stubbs AJ, Torriani M. Pelvic morphology in ischiofemoral impingement. Skeletal Radiol. 2015 Feb;44(2):249-53. doi: 10.1007/s00256-014-2041-0. Epub 2014 Nov 6. — View Citation

Coskun Benlidayi I, Guzel R, Basaran S, Aksungur EH, Seydaoglu G. Is coxa valga a predictor for the severity of knee osteoarthritis? A cross-sectional study. Surg Radiol Anat. 2015 May;37(4):369-76. doi: 10.1007/s00276-014-1359-6. Epub 2014 Aug 12. — View Citation

Durrani Z, Winnie AP. Piriformis muscle syndrome: an underdiagnosed cause of sciatica. J Pain Symptom Manage. 1991 Aug;6(6):374-9. — View Citation

Elbuken F, Baykara M, Ozturk C. Standardisation of the neck-shaft angle and measurement of age-, gender- and BMI-related changes in the femoral neck using DXA. Singapore Med J. 2012 Sep;53(9):587-90. — View Citation

Fearon A, Stephens S, Cook J, Smith P, Neeman T, Cormick W, Scarvell J. The relationship of femoral neck shaft angle and adiposity to greater trochanteric pain syndrome in women. A case control morphology and anthropometric study. Br J Sports Med. 2012 Se — View Citation

Fischer CS, Kühn JP, Völzke H, Ittermann T, Gümbel D, Kasch R, Haralambiev L, Laqua R, Hinz P, Lange J. The neck-shaft angle: an update on reference values and associated factors. Acta Orthop. 2020 Feb;91(1):53-57. doi: 10.1080/17453674.2019.1690873. Epub — View Citation

Gilligan I, Chandraphak S, Mahakkanukrauh P. Femoral neck-shaft angle in humans: variation relating to climate, clothing, lifestyle, sex, age and side. J Anat. 2013 Aug;223(2):133-51. doi: 10.1111/joa.12073. Epub 2013 Jun 19. — View Citation

Gómez-Hoyos J, Schröder R, Reddy M, Palmer IJ, Martin HD. Femoral Neck Anteversion and Lesser Trochanteric Retroversion in Patients With Ischiofemoral Impingement: A Case-Control Magnetic Resonance Imaging Study. Arthroscopy. 2016 Jan;32(1):13-8. doi: 10. — View Citation

Güvençer M, Akyer P, Iyem C, Tetik S, Naderi S. Anatomic considerations and the relationship between the piriformis muscle and the sciatic nerve. Surg Radiol Anat. 2008 Aug;30(6):467-74. doi: 10.1007/s00276-008-0350-5. Epub 2008 May 6. — View Citation

Haladaj R, Pingot M, Polguj M, Wysiadecki G, Topol M. Anthropometric Study of the Piriformis Muscle and Sciatic Nerve: A Morphological Analysis in a Polish Population. Med Sci Monit. 2015 Dec 2;21:3760-8. — View Citation

Hallin RP. Sciatic pain and the piriformis muscle. Postgrad Med. 1983 Aug;74(2):69-72. — View Citation

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. Review. — View 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. Review. — View 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. Review. — View Citation

Kean Chen C, Nizar AJ. Prevalence of piriformis syndrome in chronic low back pain patients. A clinical diagnosis with modified FAIR test. Pain Pract. 2013 Apr;13(4):276-81. doi: 10.1111/j.1533-2500.2012.00585.x. Epub 2012 Aug 2. — View Citation

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

Krueger DR, Windler M, Geßlein M, Schuetz M, Perka C, Schroeder JH. Is the evaluation of the anterior inferior iliac spine (AIIS) in the AP pelvis possible? Analysis of conventional X-rays and 3D-CT reconstructions. Arch Orthop Trauma Surg. 2017 Jul;137(7 — View Citation

Menge TJ, Truex NW. Femoroacetabular impingement: a common cause of hip pain. Phys Sportsmed. 2018 May;46(2):139-144. doi: 10.1080/00913847.2018.1436844. Epub 2018 Feb 13. Review. — View 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. — View Citation

Niu CC, Lai PL, Fu TS, Chen LH, Chen WJ. Ruling out piriformis syndrome before diagnosing lumbar radiculopathy. Chang Gung Med J. 2009 Mar-Apr;32(2):182-7. — View Citation

Pace JB, Henning C. Episacroiliac lipoma. Am Fam Physician. 1972 Sep;6(3):70-3. — View 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. Review. — View 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. Review. — View Citation

Rodrigue T, Hardy RW. Diagnosis and treatment of piriformis syndrome. Neurosurg Clin N Am. 2001 Apr;12(2):311-9. — View Citation

* Note: There are 26 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Femoral Neck-Shaft Angle (NSA) The NSA, also called caput collum-diaphyseal angle or inclination angle, defined as the angle between the longitudinal femoral shaft axis and femoral head-neck axis. The measurement was evaluated by two different investigators immediately after the pelvis anteroposterior radiography was taken.
Primary Posterior Superior Iliac Spine (PSIS)- Trochanter Major (TM) The distance between the posterior superior iliac spine and the greater trochanter The measurement was evaluated by two different investigators immediately after the pelvis anteroposterior radiography was taken.
Primary PSIS-Ischial Tuberosity (IT) The distance between the posterior superior iliac spine and the apex of the ischial tuberosity The measurement was evaluated by two different investigators immediately after the pelvis anteroposterior radiography was taken.
Primary IT-TM The distance between the apex of the ischial tuberosity and the greater trochanter The measurement was evaluated by two different investigators immediately after the pelvis anteroposterior radiography was taken.
Primary Sacrum-TM The distance between the sacrum and the greater trochanter The measurement was evaluated by two different investigators immediately after the pelvis anteroposterior radiography was taken.
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