Pelvic and Hip Morphometry in Piriformis Syndrome

NCT ID: NCT04600024

Last Updated: 2020-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-20

Study Completion Date

2020-06-18

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Piriformis Muscle Syndrome Anthropometry

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Piriformis syndrome group

Patients who were diagnosed as PS by diagnostic injection with ultrasound guidance

Ultrasound guided diagnostic injection

Intervention Type DIAGNOSTIC_TEST

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.

Age and sex match control group

Patients who were excluded from the diagnosis of PS and had anteroposterior (AP) direct radiographic imaging

No interventions assigned to this group

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* A dramatic relief of pain following piriformis muscle local anesthetic injection


-Having Anteroposterior pelvic radiographs for other medical reasons

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


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fatih Sultan Mehmet Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gamze Güleç, MD

Role: STUDY_DIRECTOR

Fatih Sultan Mehmet Training and Research Hospital

Ilknur Aktas, MD

Role: STUDY_DIRECTOR

Fatih Sultan Mehmet Training and Research Hospital

Feyza Unlu Ozkan, MD

Role: STUDY_CHAIR

Fatih Sultan Mehmet Training and Research Hospital

Locations

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Fatih Sultan Mehmet Research and Traning Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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

Reference Type BACKGROUND
PMID: 19466717 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23893704 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20596735 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15062719 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31102324 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 10428125 (View on PubMed)

Pace JB, Henning C. Episacroiliac lipoma. Am Fam Physician. 1972 Sep;6(3):70-3. No abstract available.

Reference Type BACKGROUND
PMID: 4262540 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25113012 (View on PubMed)

Durrani Z, Winnie AP. Piriformis muscle syndrome: an underdiagnosed cause of sciatica. J Pain Symptom Manage. 1991 Aug;6(6):374-9. doi: 10.1016/0885-3924(91)90029-4.

Reference Type RESULT
PMID: 1880438 (View on PubMed)

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.

Reference Type RESULT
PMID: 28836092 (View on PubMed)

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.

Reference Type RESULT
PMID: 22863240 (View on PubMed)

Hallin RP. Sciatic pain and the piriformis muscle. Postgrad Med. 1983 Aug;74(2):69-72. doi: 10.1080/00325481.1983.11698378. No abstract available.

Reference Type RESULT
PMID: 6878094 (View on PubMed)

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.

Reference Type RESULT
PMID: 19403008 (View on PubMed)

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

Reference Type RESULT
PMID: 11525209 (View on PubMed)

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.

Reference Type RESULT
PMID: 25794202 (View on PubMed)

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. doi: 10.12659/msm.894353.

Reference Type RESULT
PMID: 26629744 (View on PubMed)

Guvencer 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.

Reference Type RESULT
PMID: 18458807 (View on PubMed)

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.

Reference Type RESULT
PMID: 29406812 (View on PubMed)

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):975-980. doi: 10.1007/s00402-017-2694-y. Epub 2017 Apr 21.

Reference Type RESULT
PMID: 28432458 (View on PubMed)

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.

Reference Type RESULT
PMID: 25371087 (View on PubMed)

Gomez-Hoyos J, Schroder 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: 10.1016/j.arthro.2015.06.034. Epub 2015 Sep 7.

Reference Type RESULT
PMID: 26358634 (View on PubMed)

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 14.

Reference Type RESULT
PMID: 28070521 (View on PubMed)

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.

Reference Type RESULT
PMID: 23023899 (View on PubMed)

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.

Reference Type RESULT
PMID: 23781912 (View on PubMed)

Fischer CS, Kuhn JP, Volzke H, Ittermann T, Gumbel 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 2019 Nov 18.

Reference Type RESULT
PMID: 31735107 (View on PubMed)

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 Sep;46(12):888-92. doi: 10.1136/bjsports-2011-090744. Epub 2012 Apr 30.

Reference Type RESULT
PMID: 22547561 (View on PubMed)

Other Identifiers

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FSMEAH

Identifier Type: -

Identifier Source: org_study_id